Cardiopulmonary Function in Adults Born With a Ventricular Septal Defect

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Brief Title

Cardiopulmonary Function in Adults Born With a Ventricular Septal Defect

Official Title

Cardiopulmonary Function in Adults Born With a Ventricular Septal Defect

Brief Summary

      The overall objective for this study is to evaluate the cardiopulmonary function of
      VSD-patients compared with healthy age- and gender-matched controls. VSD patients with a
      surgically corrected defect and VSD patients with a small persistent defect will be included.
    

Detailed Description

      1. Title Cardiopulmonary capacity past the age of 40 - adults with either a persistent or a
           surgically repaired ventricular septal defect

        2. Background:

           Over the last decades, the treatment possibilities in pediatric cardiology and cardiac
           surgery have improved markedly and accordingly, more than 90% of children born with a
           congenital heart disease now reach adulthood [1,2]. As a result, the population of
           adults is today greater than that of children with congenital cardiac defects [3] and
           consequently, the focus has started to shift more towards the long-term outcome of the
           growing adult population. Among the most common cardiac defects is the ventricular
           septal defect (VSD), seen as a hole of varying position, size and significance in the
           wall separating the two pumping chambers of the heart. The VSD occurs at a rate of 2-3
           per 1000 life-births [4,5] and is at large diagnosed during childhood. In the first
           decade of life, approximately 30% of the VSDs will close spontaneously[6], with a
           declining number closing naturally with increasing age[7]. VSDs that do not close
           spontaneously are considered to be of either hemodynamic importance or not. Patients
           born with a hemodynamically significant and operable VSD will undergo surgical or
           catheter-based closure, mostly at an early age, whereas the rest are considered too
           small and insignificant to be of any hemodynamic importance.

           Common for both the surgically closed and the small, unrepaired VSDs is that the
           long-term outcome of these patients is thought to be excellent. Patients who have
           undergone closure of their defect are considered to be "cured" and few years following
           successful surgery, they are discharged from further follow-up visits in the health care
           system. Similarly, patients with small, unrepaired VSDs are followed in their first
           decades of life with follow-up visits, with the majority being discharged when they
           reach adulthood. Therefore, very little is known on the possible consequences of a
           congenital VSD on the physical functioning in later adulthood. Recently, researchers
           from our institution assessed the physical capacity in both open and closed VSDs,
           focusing on the early adulthood, and found a number of physical parameters affected in
           patients when comparing them with their healthy peers. In patients in their early
           twenties with an operated VSD, a 20% lower exercise capacity and an abnormal
           contractility was found during physical activity compared with a group of healthy
           controls [8,9]. Young adults, in their mid-twenties, with small, open VSDs exhibited a
           similarly reduced exercise capacity as compared with healthy peers [10,11], and in both
           open and closed patients, health-related quality of life was found to be affected with a
           lower self-assessed physical functioning compared with healthy controls [9,10].

           Young adults with open and closed VSDs also demonstrated a reduced ventilatory response
           during exercise [10,12]. This led to further detailed examination of their pulmonary
           function in a newly completed study on similarly aged patients with either open or
           closed VSDs[13]. Both patient groups displayed a degree of limited pulmonary function,
           especially in the dynamic measurements and most pronounced in the surgically corrected
           patients. Other recent studies have also found degrees of limitations in these patients
           [14-16]. However, common for all studies is that the patients investigated are usually
           in their mid-twenties with no patient reaching the age of 40 years. Therefore, it is not
           yet known whether any of these documented limitations will progress, decrease or stay
           unchanged with increasing age. As the group of patients with congenital VSDs grows
           older, age-related factors such as acquired hypertension, coronary artery disease, and
           other cardiovascular problems will start emerging and perhaps accelerate any former
           trivial symptoms related to their underlying cardiac anomaly. How this will further
           affect the already found limitations in young adults is unknown. Therefore, we feel
           there is an unmet need for a prospective, clinical study investigating how these
           patients are doing past the age of 40 as compared with their peers.

        3. Study objectives and purpose:

           3.1 Objectives: The overall objective of this study is to investigate a group of adults,
           age 40 or above, who are living with a small, unrepaired or a surgically corrected
           ventricular septal defect. Outcomes will be illustrated through an extensive pulmonary
           function study performed at rest, questionnaires, two different exercise studies and a
           study on heart rate variability through Holter monitor. Results of the two patient
           groups will be compared with those of healthy, age-matched controls.

           3.2 Hypotheses: I. Adult patients, age 40 or above, with small, unrepaired VSDs or
           surgically corrected VSDs will demonstrate a reduced pulmonary function at rest compared
           with healthy, age-matched controls.

           II. Adult patients, age 40 or above, with small, unrepaired VSDs or surgically corrected
           VSDs will experience a 20% reduced exercise capacity during bicycle exercise tests
           compared with healthy, age-matched controls.

           III. Adult patients, age 40 or above, with small, unrepaired VSDs or surgically
           corrected VSDs will experience reduced minute ventilation during bicycle exercise tests
           compared with healthy, age-matched controls.

           IV. Adult patients, age 40 or above, with small, unrepaired VSDs or surgically corrected
           VSDs will reach lower scores on health-related quality of life as compared with healthy,
           age-matched controls.

           V. Adult patients, age 40 or above, with small, unrepaired VSDs or surgically corrected
           VSDs will reach a maximum of force frequency quicker than healthy, age-matched controls
           when examined by echocardiography during exercise.

           VI. Adult patients, age 40 or above, with small, unrepaired VSDs or surgically corrected
           VSDs will have an increased rate of arrhythmias and a reduced heart rate variability
           compared with healthy controls

           3.2 Endpoints: The primary endpoint of the study is peak oxygen uptake (ml O2/kg/min)
           during exercise. Secondary endpoints include forced expiratory volume in one second at
           rest, peak isovolumetric acceleration (cm/s2) during exercise, airway resistance
           (R5-20), diffusion capacity (DLCO), alveolar volume, health-related quality of life and
           heart rate.

        4. Materials and Methods:

           4.1 Study population: The study population will consist of three groups; a group of
           small unrepaired VSDs, a group of surgically corrected VSDs and a group of healthy,
           age-matched controls. Each group is aimed at including 20 participants.

           4.1.1 Inclusion criteria: By searching the Electronic Patient Journal (EPJ), patients
           born between 1938 and 1978 will be included if they are registered with DX Q21.0; the
           International Classification of Diseases (ICD) code for a ventricular septal defect, and
           if the defect is unrepaired in accordance with criteria from the European Society of
           Cardiology Guidelines [5] or is repaired as documented by the procedural code KFHB.
           Recruitment of healthy control subjects will take place by means of adverts at the
           website www.forsoegspersoner.dk. Control subjects will be matched by likewise
           age-groups.

           4.1.2 Exclusion criteria: Patients and control subjects will be excluded from the
           project if they meet any one of the following: lack of medical record, serious
           congenital cardiac abnormalities, lack of Danish language skills, severe lung or heart
           disease, syndromes, such as Down's, mentally or physically incompetent to perform the
           bicycle test. Participants will be informed of the exclusion criteria at the initial
           information interview before inclusion in the study. Oral verification is considered
           sufficient to verify the exclusion criteria.

           4.1.3 Enrolment: Patients who meet the abovementioned criteria, and control subjects,
           who show interest will receive a letter. This will include written participation
           information as well as the appendix "Forsøgspersoners rettigheder i et
           sundhedsvidenskabeligt forskningsprojekt" and "Før du beslutter dig" composed by the
           Danish Research Ethics Committee. Through our written information, we urge participants
           to carefully read this appendix. In the written information the right to bring another
           person to the meeting is also stated. A reply card and a prepaid envelop will also be
           included in the letter, with which participants can accept or reject further information
           of the project. Participants, who accept partaking in the project, will receive a date
           by their preferred means of contact; telephone, e-mail or a letter. At this date they
           will meet at the hospital in order to receive oral information on the project. One of
           the project organisers will furthermore certify that the participant fulfil in- and
           exclusion criteria. After this, they will be provided with the consent form. The oral
           session will be allocated as much time as needed for a complete briefing and answering
           questions and no interference will occur.

           At all times, it will be possible to obtain further information by contacting the
           project organiser, Marie Maagaard Sørensen or Filip C.A. Eckerström. Contact information
           will be evident on all material received. Documented travel expenses in connection with
           participation in the project will be economically reimbursed. Potential project
           participants will be informed of this through the information material.

           4.2 Study-design: The study is designed as a prospective, long-term follow-up study and
           will be conducted between September 2018 and June 2021. It consists of five elements;
           pulmonary function tests performed at rest, a maximal exercise test measuring the peak
           oxygen uptake of the participant, two questionnaires (one on health-related quality of
           life, one on habitual physical activity), a supine bicycle test combined with
           echocardiography for the assessment of cardiac contractility and wearing a Holter
           monitor. All tests are performed once at the same location.

           The timeframe for the tests are estimated at lasting three hours in total. The order of
           tests will commence with the assessment of pulmonary function at rest which is estimated
           at lasting half an hour. After this, the maximal bicycle test measuring oxygen uptake
           will take place, lasting another half hour. This will be followed by an hour of resting
           in order to ensure some physical restitution before the supine bicycle test, which is
           likewise estimated at half an hour. In the hour between the two bicycle tests, the two
           questionnaires are intended to be completed. Following the second bicycle test, the
           participant will be equipped with a Holter monitor and will then have completed the full
           list of examinations. Further details on each test will be mentioned under section 4.5
           Data collection.

           4.3 Power calculation: The number of participants needed to be included in order to
           increase the probability of statistical significance is estimated based on the primary
           endpoint from Hypothesis I; peak Oxygen uptake during exercise. This has been chosen as
           a variable as it has previously been found to be statistically and clinically different
           in young adults with either unrepaired VSDs [10] or surgically corrected VSDs [9]
           compared with healthy peers. The results from Heiberg et al are chosen for the power
           calculation, where a reduced peak Oxygen uptake in surgically corrected VSDs of
           38.0±8.2) ml O2/kg/min was measured along with a mean value of 47.9‡6.5ml O2/kg/min in
           healthy, age- and gender-matched controls. It is equally expected in this project that
           the older patients, both small unrepaired and surgically corrected VSDs, will reach a
           lower peak Oxygen uptake compared with a healthy group of controls during bicycle
           exercise. A difference of 80% is likewise expected like that of the previously found
           difference with the same standard deviations. A statistical power of 90% and a
           significance level of 5% are set, indicating that at least 19 participants are needed to
           be included in each group. This is considered possible from an assessment of
           participants fulfilling the inclusion criteria from a diagnosis-code-search in the
           EPJ-system, where several hundred participants were readily identified. We aim at
           including 20 participants in each group.

           4.4 Data analyses and statistics All calculations will be carried out using the
           statistical software Stata 11.2 (StataCorp LP, College Station, TX, USA). For all
           graphical description, Graph Pad Prism 6 (GraphPad Software, La Jolla, CA, USA) will be
           used. Continuous, normally distributed data will be reported as means with ±standard
           deviations (SD) or as medians with 95% confidence intervals or total range. For normally
           distributed data, the unpaired Student's t-test will be used, and for normally
           distributed data with unequal SD the unequal Student's t-test will be used. For
           non-normally distributed data the Mann-Whitney-Wilcoxon rank-sum test will be chosen.
           Regarding the assessment of reproducibility, which will be relevant when analysis data
           from Hypothesis V - Contractility during exercise, the Intraclass Correlation Coefficient
           (ICC)17 will be chosen using a two-way mixed model for the differences between
           measurements to estimate agreements of inter- and intraobservers. Correlation will be
           checked using simple regression analyses. A p-value <0.05 will be considered
           statistically significant for all results.

           4.5 Data collection - test description 4.5.1 Hypothesis I - Pulmonary function at rest
           In order to thoroughly evaluate the pulmonary function at rest, a number of tests will
           be applied so the entire ventilatory system will be assessed. Below, each specific lung
           function test will be considered.

           4.5.1.1 Dynamic lung function The dynamic lung function will be evaluated using a
           spirometry performed with the Jaeger MasterScreen Pneumo spirometer by Carefusion or the
           Jager MasterScreen PFTpro diffusion system with bodybox by Intramedic. The tests will be
           performed in accordance to American Thoracic Society/European Respiratory Society
           Guidelines [18]. The participants will exhale trough a mouthpiece and the equipment will
           then be able to measure airway flow dynamics. The test will include forced expiratory
           volume in one second, forced vital capacity, the ratio between the two volumes, and peak
           expiratory flow. The values are automatically given by the trial equipment after testing
           and they will be described as volumes and as percentage of expected.

           4.5.1.2. Plethysmography (Static lung function) The plethysmography will be performed
           with Intramedics Jaeger MasterScreen PFTpro difussionssystem and Bodybox from
           CareFusion. The participant sits inside an airtight cabinet where they will ventilate
           through a single mouthpiece. At the end of normal expiration, the mouthpiece will close
           and the participant is then asked to make an inspiratory effort. The lungs expand,
           decreasing pressure within the lungs, increasing lung volume. This in turn increases
           pressure in the cabinet, and increases bodybox volume. The equipment can then determine
           different lung parametres of which we will measure total lung capacity, residual volume,
           functional residual capcity and specific airway resistance (sRAW, kPa/sec) [19].

           4.5.1.3 Lung Clearance Index (LCI) The LCI will be performed using the Ecomedics
           Exhalyzer D with N2 option for washout, Multiple Breath Washout (MBW) and Single Breath
           Washout (SBW), by Intramedic. A flowmeter and gas sampling port is fitted to a
           mouthpiece and connected to a flow-past tube which supply tracer gas during wash-in and
           remove at the start of washout. With MBW the participant breath trough a mouthpiece and
           the equipment will trace the wash-out of the tracer gas. The tracer gas will be NO2
           which is normally resident in the lungs and neither absorbed nor excreted by the body in
           any significant degree. NO2 wash-out will be traced during normal tidal ventilation with
           100% oxygen and with every breath there should be a gradual fall in peak concentration
           of the tracer. Wash-out is deemed complete when the end-tidal tracer gas concentration
           is 1/40th of starting concentration [20-22]. Hereby the equipment can analyse LCI 2,5
           (LCI is defined as the cumulative expired volume (CEV) divided by the functional
           residual capacity (FRC), Scond (ventilation heterogeneity generated in the conductive
           lung zone) and Sacin (ventilation heterogeneity generated peripheral to the acinar
           entrance). The values are automatically given by the trial equipment after testing. All
           values are described as percentage of expected.

           4.5.1.4 Diffusion Capacity: The diffusion capacity test will be performed on the same
           equipment as the plethysmography. The test determines lung Carbon Monoxide diffusion
           capacity (DLCO) and alveolar volume (VA) expressed as percentage of expected value. For
           the DLCO, the participants will ventilate through the mouthpiece. First they will take a
           deep breath in and exhale to residual volume. Afterwards they will inhale rapidly with a
           gas mixture containing approximately 0.3% CO, 10% He, 21% O2 and balanced N2. They will
           hold their breaths for 9 seconds and then exhale rapidly. VA is the volume of
           distributed helium, expressed in body temperature and pressure saturated (BTPS) units,
           from a single-breath DLCO test [23]. The values are automatically given by the study
           equipment after testing.

           4.5.1.5 Impulse Oscillometry (IOS) IOS will be performed using the Carefusion m Vyntus
           Impulse oscillometer with SentrySuite software and Vyntus Spirometer. Participants will
           perform normal tidal ventilation through the equipment mouthpiece while the loudspeaker
           generates an impulse-shaped pressure signal into their respiratory system. They will
           breath tidally for 30 seconds, as instructed by our trained personal. The equipment will
           then be able to analyse resistance in of the respiratory system at 5 Hz (R5), and at 20
           Hz (R20) and the difference between the two measured resistances (Diff 5-20) [24,25]. It
           will be ascertained that each test results in at least three reproducible manoeuvres
           without artifacts caused by coughing, swallowing, vocalization or breath holding. The
           participants mean values will then be used for further trial analysis. The values are
           automatically given by the trial equipment after testing.

           4.5.3 Hypothesis II and III - Exercise capacity Exercise capacity will be tested on a
           Lode Corival ® ergometer cycle. With the Jaeger MaesterScreen CPX software system, we
           will monitor pulmonary ventilation and gas exchange in a breath-by-breath measurement.
           During test sessions, heart rate, blood pressure and electrocardiogram, will be measured
           continuously. An individual workload protocol based on the subject's body-mass, gender
           and exercise habits will be determined before the first test. Participants are initially
           examined at rest while strapped on to the ergometer cycle pedals for 2 minutes.
           Afterwards, they will perform continuous leg exercise with gradually incremented
           workloads until complete exhaustion. The participants will be instructed to maintain a
           cycling speed of 60 to 70 rounds/min, not to talk or stand up in the pedals during
           testing, and to keep pedalling until complete exhaustion. Maximal exhaustion is defined
           as a respiratory exchange ratio of 1.10 and a heart rate plateau or a plateau of oxygen
           uptake [26]. Blood pressure will be measured with an arm cuff at every third minute.The
           assumed test time is 8 to 12 minutes per test.

           4.5.4 Hypothesis IV - Questionnaires Participants will be asked to fill out a
           questionnaire in order to gather information of the weekly amount of physical activity.
           This is reviewed with the purpose of illustrating if the patients are restricted in any
           ways compared to the healthy controls in regards to their exercising habits, and for
           this assessment, the standardized International Physical Activity Questionnaire (IPAQ)
           [27] will be chosen. Also, participants will be asked to fill out the health survey
           Short-Form-36 (SF-36) with the aim of documenting Health-Related-Quality-of-Life
           (HRQoL). The latter is chosen based on the need for a generalized quality of health
           questionnaire, which is widely used and thus, provides data which is easily comparable
           to other studies.

           4.5.5 Hypothesis V - Contractility during exercise Each individual will undergo
           echocardiographic scans in accordance with recommendations from Dansk Cardiologisk
           Selskab [28]. Echocardiography will be performed with the participants in supine
           position, while connected to a bicycle ergometer, in order to carry out an exercise
           stress echocardiography. Participants will initially be scanned at rest and then start
           pedalling at a steady pace of app. 60-70 rpm with scans being performed at predefined
           times with a duration of app. 30 seconds. The test will end with either exhaustion
           despite encouragement to continue or when a target heart rate of app 160-min is reached
           (which is measured continuously throughout the test). This target heart rate is chosen
           as echocardiographic recordings lose quality beyond this level due to heart movements
           and lung interference [29]. The exercise stress echocardiography is performed in order
           to gather information on the force-frequency relationship (FFR), which describes the
           property of the cardiac muscle to change contractile force in accordance with heart
           rate. Changes in the configuration of the myocardium may alter this ability and result
           in a sloping of the FFR in patients with cardiac abnormalities compared to healthy
           subjects [30]. An important measure of FFR is the isolvolumetric acceleration, measured
           in cm/sec2, as this is not dependent on loading conditions of the pumping chambers, and
           holds a high rate of reproducibility. It is especially stable in the face of a changing
           afterload, as it is measured in the isovolumetric contraction period prior to semilunar
           valve opening.

           4.5.6 Hypothesis VI - Heart rate variability Following the second bicycle test,
           participants will be equipped with a Holter monitor in order to assess their
           heart-rate-variability and possible arrhythmias. ECG will be monitored with a 2-channel
           Holter monitor (SPACELABS HEALTHCARE Lifecard CF Digital Holter Recorder). It will be
           attached to the subject by the investigators, as instructed by a Holter-Nurse from the
           Dept. of Cardiology, Aarhus University Hospital. Participants will be instructed in how
           to handle the Holter monitors at home and provided with an information document on how
           to handle the Holter monitor and how to return it. They will also be given an incident
           journal, where they can register if they experience any symptoms they might relate to
           their cardiopulmonary function, with time of incident. This will be used for the Holter
           data analysis. Participants will be wearing the Holter monitor for a full 24 hours after
           activation following the second bicycle test. They will receive a pre-paid addressed
           return-box and instruction to mail the Holter monitor, memory card, wires, and leftover
           electrodes back to our institution as soon as the Holter-recording is over. If the
           Holter monitor is not returned within the first week, we hold the right to contact the
           participant and remind them to return the Holter monitor until it is in our custody.

        5. Ethical Consideration:

           All data will be made anonymous and all included participant will receive a 4-digit
           identification code which will be evident on all subject study data. The identification
           list with participant personal data will be stored in REDCap, the legal base of the
           university. Data for each participant will be stored in their REDcap file (marked with
           study number). All digitalised data will be stored on two external harddrives that is
           kept safe behind two locked doors. The study is conducted in accordance with the
           Helsinki declaration and Danish law. The project will obtain permission from the Danish
           Protection Agency and the National Committee on Health Research Ethics. Data will be
           handled in agreement with the personal data handling law and the participants' safety is
           always the number one priority during this study.

           All examinations throughout this project are free of any risks to the participants. The
           momentary strain from participating in the tests is judged as being acceptable in the
           light of the importance this project could have for patients with small, unrepaired or
           surgically corrected VSDs. The participant safety is always the leading priority of the
           investigations. Compensations to cover transport expenses will be provided, but not
           reimbursement to cover lost earnings or any type of payment for participating. This
           project holds no dependence - neither economically nor in ways of interest - to any
           potential sponsors. Granted money from foundations will be transferred to a
           foundation-account which is managed by the Foundation-administration at Aarhus
           University-hospital, Skejby. Names on potential sponsors will be depicted in later
           published material.

        6. Resources:

           The study is based from the department of Cardiothoracic Surgery on Aarhus University
           Hospital, which has a longstanding tradition for clinical trials. All tests will be
           performed by medical personnel who are trained in conduction of clinical studies.The
           Project Coordinators Marie Maagaard Sørensen and Filip C. A. Eckerstöm have both
           previously conducted and completed clinical studies at the department. Both are
           instructed and educated in the trial investigations and will assist the participants
           during the trial days. They will furthermore function as contacts for the trial.
           Professor of cardiothoracic surgery Vibeke Elisabeth Hjortdal has vast experience of
           both clinical and experimental cardiovascular research and will be the main supervisor
           of the project. All necessary equipment and facilities required to carry out this study
           are available or provided by the Department of Cardiothoracic and Vascular Surgery, the
           Department of Paediatrics and the Department of Cardiology at Aarhus University
           Hospital.

        7. Prospective publication:

      The project is planned to result in at least one scientific article on the exercise capacity,
      cardiac contractility, heart rate variability and extended pulmonary function in adults, age
      40 or above with a congenital VSD, published in an international journal. Positive as well as
      negative and inconclusive results will be published.
    


Study Type

Observational


Primary Outcome

Peak oxygen uptake

Secondary Outcome

 Forced expiratory volume in one second (FEV1)

Condition

Ventricular Septal Defect

Intervention

Cardiopulmonary function

Study Arms / Comparison Groups

 Surgically closed VSDs
Description:  Patients born with a ventricular septal defect, which have been closed in early childhood.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

95

Start Date

September 24, 2018

Completion Date

September 1, 2019

Primary Completion Date

August 12, 2019

Eligibility Criteria

        Inclusion:

          -  Patients born between 1938 and 1978.

          -  Patients registered with DX Q21.0, and if the defect is unrepaired in accordance with
             criteria from the ESC guidelines 5 or is repaired as documented by the procedural code
             KFHB.

        Recruitment of healthy control subjects will take place by means of adverts at the website
        www.forsoegspersoner.dk. Control subjects will be matched by likewise age-groups.

        Exclusion:

          -  Lack of medical record

          -  Serious congenital cardiac abnormalities

          -  Lack of Danish language skills

          -  Severe lung or heart disease

          -  Syndromes, such as Down's

          -  Mentally or physically incompetent to perform the tests.

        Participants will be informed of the exclusion criteria at the initial information
        interview before inclusion in the study. Oral verification is considered sufficient to
        verify the exclusion criteria.
      

Gender

All

Ages

40 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Vibeke E Hjortdal, MD, PhD, DMSc, , 

Location Countries

Denmark

Location Countries

Denmark

Administrative Informations


NCT ID

NCT03684161

Organization ID

FEMM4


Responsible Party

Sponsor

Study Sponsor

University of Aarhus


Study Sponsor

Vibeke E Hjortdal, MD, PhD, DMSc, Principal Investigator, Dept. of Cardiothoracic and Vascular Surgery


Verification Date

September 2018