Depression and Major Adverse Events in Older Patients Who Undergo a Transcatheter Aortic Valve Implantation

Brief Title

Depression and Major Adverse Events in Older Patients Who Undergo a Transcatheter Aortic Valve Implantation

Official Title

Impact of Depression on 1-year Major Adverse Events in Patients Aged 75 or Older Who Undergo Transcatheter Aortic Valve Implantation (TAVIDEP)

Brief Summary

      Depression, screened using the Geriatric Depression Scale (GDS) Short Form, has recently been
      found to be associated with a 3-fold increase in 1-year mortality after aortic valve
      replacement (AVR) in patients aged 70 or older. The main objective of the study is to
      evaluate whether the 1-year incidence of major adverse cardiac and cerebrovascular events
      (MACCEs), evaluated according to the valve academic research consortium 2 (VARC-2 criteria),
      in patients aged 75 or older who undergo a transcatheter aortic valve implantation (TAVI),
      should be similar in patients with depression systematically screened (using the 15-item GDS
      score), confirmed, and handled by a psychiatrist, and in patients without depression
      detected, after adjusting for frailty criteria and comorbidities.

Detailed Description

- Setting: the University hospital of Montpellier and the Perpignan hospital (France)

- Study population: 300 patients undergoing a TAVI, recruited over a 2-year period and
followed for 12 months.

- Measurements at baseline: depression systematically screened by the 15-item Geriatric
Depression Scale before TAVI. If the score is 4 or higher, patients will be evaluated by
a psychiatrist and the patient will be treated according to current guidelines. Other
possible confounders of the relationship between depression and poor outcomes: age;
Fried's frailty phenotype; short physical performance battery; comorbidities; disability
in the activities of daily living (ADL) and instrumental activities of daily living
(IADL); cognitive function (Mini Mental State Examination; Clock Test score; Montreal
cognitive assessment).

- Measurements (by telephone): 30 days after TAVI: MACCEs and hospitalization stay
duration; 6 and 12 months after TAVI: MACCEs, 15-item GDS, ADL and IADL, new medical
problem since the last visit, hospital admission, death, compliance and adverse effects
of antidepressant drugs if applicable.

In case of withdrawal, the investigator will perform all examinations scheduled for the final
study visit, which includes recording of AEs. In any case, the patient will be treated in
accordance with standard care in the Montpellier and Perpignan centers.

Our hypothesis is that 40% of patients aged 75 or older will meet the criteria for depression
(1-2), and that the 12-month incidence of MACCEs will be of 25% in patients without
depression and of 50% in patients with depression. Our assumption is that the treatment of
depression will reduce by 50% the incidence of MACCEs, to reach comparable incidence
(relative difference of 10% or less) as the incidence observed in patients without
depression.

To test this hypothesis, the number of patients with depression is 110 and the number of
patients without depression is 165 (Total: 275 patients) to have a power of 90%. Considering
a loss to follow-up rate of 10%, 300 patients will be included in the present study.

-Population analysis : The data will be entered into an eCRF (Ennov clinical) allowing
consistencies control and remote monitoring. The data will also be validated on site from the
source data by the TEC of the study. All included subjects will be taken into account in the
description of the population. Data will be analyzed under the responsibility of
Marie-Christine PICOT (Epidemiology and clinical research unit of the Montpellier University
Hospital) with SAS software version 9 (SAS Institute, Cary, N.C.).

The statistical analysis plan (SAP), covering all the analyses to be performed on all data,
will be written before database lock. For all collected variables, descriptive statistics
will be calculated according to the level of measurement. For metric variables, a check
whether the data can be assumed normally distributed will be first conducted. For normally
distributed variables, mean and standard deviation will be calculated. For skewed variables,
median and range will be used. In case of categorical variables group proportions and
contingency tables will be prepared.

A comparison of baseline parameters between patients with and without depression (age,
gender, number of drugs taken, Fried's and Rockwood's frailty criteria, SPPB, TUG, HRQOL,
ADL, IADL, MMSE, Clock-Drawing test, MOCA; lives alone or not) will be conducted.

The incidence of MACCEs and other endpoints (mortality, hospitalization and nursing home
admission rate, ADL, IADL score) at 6 and 12 months after TAVI will be compared between
patients screened and treated for depression and in patients without depression. All analyses
will be performed before and after adjustment for parameters distinguishing patients with
confirmed depression and without depression at baseline.

The efficacy of the treatment of depression started by the psychiatrist will be assessed by
comparing the 15item GDS, CES-D, Lille Apathy rating scale, HRQOL at baseline and at 6 and 12
months. The AE of antidepressant drugs will be described, such as the rate of withdrawal.

If the incidence of MACCEs and other outcomes is comparable in both groups of patients, the
present study will provide preliminary results in order to conduct a randomized control trial
to demonstrate that the systematic screening of depression and its treatment can reduce the
incidence of MACCEs in patients aged 75 or older who undergo a TAVI.

Study Type

Observational

Primary Outcome

Number of Incidence of MACCEs

Secondary Outcome

 Number of Incidence of MACCEs

Condition

Depression

Publications

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

Recruitment Information

Estimated Enrollment

Start Date

June 1, 2019

Completion Date

June 30, 2019

Primary Completion Date

June 1, 2019

Eligibility Criteria

        Inclusion Criteria:

          -  Patients aged 75 years or older

          -  Patients eligible for TAVI and for study inclusion after a consensus decision of a
             multidisciplinary team including at least an interventional cardiologist, a
             cardiothoracic surgeon, a geriatrician, and an anesthetist.

          -  Subjects able to attend all scheduled visits and to comply with all trial procedures

          -  Subjects covered by public health insurance

          -  Signed informed

        Exclusion Criteria:

          -  Subject unable to read or/and write

          -  Patients with emergency procedure, clinical instability (defined as unstable vital
             signs or refractory ongoing symptoms, acute decompensated heart failure)

          -  Patients with severe neuropsychiatric impairment

          -  Planned longer stay outside the region that prevents compliance with the visit plan

          -  Subject who are in a dependency or employment with the sponsor or the investigator

          -  Participation in another clinical trial within the last 4 weeks before the screening
             date

Gender

All

Ages

75 Years - N/A

Accepts Healthy Volunteers

No

Contacts

hubert Blain, MD, PhD, ,

Administrative Informations

NCT ID

NCT03995914

Organization ID

RECHMPL19_0295

Responsible Party

Sponsor

Study Sponsor

University Hospital, Montpellier

Study Sponsor

hubert Blain, MD, PhD, Principal Investigator, University Hospital, Montpellier

Verification Date

June 2019