Identification of Parameters in rapId-proGression Subgroup Patients With Moderate Aortic Stenosis

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POLESTAR Trial – An International Multi-center Early Discharge TAVI Program REPRISE EDGE 29 mm EU Study The CONFIDENCE Registry Interest of Cardiac Computed Tomography to Optimize and Improve the Procedure of TAVI Transapical Implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System – The Engager European Pivotal Trial Post-Market Follow-up of the CENTERA Transcatheter Heart Valve System SecOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in TAVI Balloon Aortic Valvuloplasty During Surgical Aortic Valve Replacement The PROTEMBO SF Trial Adjuvant Radiation in Aortic Valvuloplasty – ARAVA Value of Oral Phytate (InsP6) in the Prevention of Progression of the Cardiovascular Calcifications Supra-Annular vs. Annular ValvEs for Small Annuli Heart Leaflet Technologies Valve Study A Study to Evaluate the Neuro-embolic Consequences of TAVR Femoral vs Radial Approach and MRI Evaluation of Strokes Mortality Post-TAVI and Correlation With Haemodynamic Parameters. 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Insertable Cardiac Monitoring Device Reactive Oxygen Species Following Aortic Valve Replacement Biological Factors Associated With Subclinical Valvular Thrombosis Hemodynamic Comparison of Tissue Aortic Valves Volume Challenge Added to DSE in the Diagnosis of Severe LFLGAS Impact of Perioperative Treatment With Intravenous Glutamine on Myocardial Protection in Cardiac Surgery Patients With Aortic Stenosis The Effects of High Spinal Anesthesia on Heart Function, Stress Response and Pain Control in Aortic Valve Surgery A Clinical Trial of Transcatheter Aortic Valves in Dialysis Patients (Japan) Erythropoietin + Iron Therapy for Anemic Patients Undergoing Aortic Valve Replacement A Study Evaluating the Effects of Ataciguat (HMR1766) on Aortic Valve Calcification Efficacy of Angiotensin Receptor Blocker Following aortIc Valve Intervention for Aortic STenOsis: a Randomized mulTi-cEntric Double-blind Phase II Study Prehabilitation to Improve Functional and Clinical Outcomes in Patients With 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Evaluated Via Modern Ballistocardiography and Seismocardiography Study of Platelet Activation by Severe Aortic Stenosis and Its Correction by Transcatheter Aortic Valve Implantation Sizing-sTrategy of Bicuspid AoRtic Valve Stenosis With Transcatheter Self-expandable Valve The Plasma Serotonin and Aortic Stenosis: a Pilot Study. 18F-NaF Uptake and Aortic Stenosis Progression Cardiovascular Rehabilitation in Patients With Severe Aortic Stenosis Submitted to Valvar Correction Aortic Stenosis and PhosphodiEsterase Type 5 iNhibition (ASPEN): A Pilot Study Clinical Outcome of Patients With Low-gradient Severe Aortic Stenosis Ultrasonic Markers for Myocardial Fibrosis and Prognosis in Aortic Stenosis Fetal Intervention for Aortic Stenosis and Evolving Hypoplastic Left Heart Syndrome The PARTNER 3 – Trial – The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis Ventricular Remodeling In Patients With Aortic Stenosis Assessed Echocardiography Podocan and Wnt Pathway in Left Ventricular Remodeling of Aortic Stenosis Preoperative Assessment of Aortic Valve Stenosis and Coronary Artery Disease Statin Therapy in Asymptomatic Aortic Stenosis Validation of the “TASQ” in Patients Undergoing SAVR or TF-TAVI Analysis and Comparative Evaluation of Aortic Calcium by Computed Tomography and Histopathology in Patients With Aortic Stenosis Improving Echo Measurements in the Diagnosis of Aortic Stenosis accuRate Evaluation of Benefit With Optimal Medical Treatment With or With-Out Transcatheter Valve Repair of PARADOXical Low Flow Low Gradient Aortic Stenosis – REBOOT-PARADOX Aortic Stenosis: Determinants and Prognostic Value of Preoperative Left Ventricular Remodeling After Valvular Replacement Randomized Study for the Optimal Treatment of Symptomatic Patients With Low Gradient Severe Aortic Valve Stenosis and Preserved Left Ventricular Ejection Fraction Microvascular Dysfunction in Aortic Stenosis Percutaneous Aortic Valve 18F System for the Treatment of Patients With Severe Aortic Stenosis Determination of the Acute Effects of Aortic Stenosis on Coronary Artery Haemodynamics Mechanism of Decompensation Evaluation – Aortic Stenosis Speckle Tracking Imaging in Patients With Low Ejection Fraction Aortic Stenosis (SPArKLE-AS) A Comparison of Advanced Imaging Techniques in Aortic Stenosis Aortic Valve Replacement Versus Conservative Treatment in Asymptomatic Severe Aortic Stenosis Microparticles in Severe Aortic Stenosis Aortic Stenosis and PhosphodiEsterase iNhibition With Aortic Valve Replacement (ASPEN-AVR): A Pilot Study An Investigational Drug on Clinical Outcomes in Patients With Aortic Stenosis (Narrowing of the Major Blood Vessel of the Heart)(MK-0653A-043 AM4)(COMPLETED) Clinical Evaluation of MDT-2111 in Subjects With Symptomatic Severe Aortic Stenosis Acute Hemodynamic Effects of Sildenafil in Patients With Severe Aortic Stenosis Transapical Transcatheter Treatment Versus Conventional 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PCSK9 Inhibitors in the Progression of Aortic Stenosis Early Surgery Versus Conventional Treatment in Very Severe Aortic Stenosis Randomized Study to Evaluate the Efficacy of Fluvastatin on Inflammatory Markers in Patients With Aortic Stenosis. 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Brief Title

Identification of Parameters in rapId-proGression Subgroup Patients With Moderate Aortic Stenosis

Official Title

Prospective Study Focused on idEntification of cliNical, Biological and Imagistic Parameters in rapId-proGression Subgroup Patients With Moderate Aortic Stenosis

Brief Summary

      The investigators aim to identify all clinical, biological, echo and imagistic parameters
      that predispose to increased progression rates in a prospective observational trial which
      will include ONLY patients with moderate AS, with the complete cardiological investigational
      tools provided in 2012. Once those parameters are found, medical and interventional treatment
      could be implemented to decrease the mortality rates.
    

Detailed Description

      1. Why this study? 1.1. Significance and difficulty of the problem being addressed. Aortic
           stenosis is the most encountered valvular disease According to the 2007 ESC guidelines
           (1), moderate aortic stenosis (AS) is defined as valve area 1.0-1.5 cm² (0.6 cm²/m² to
           0.9 cm²/m² body surface area (BSA)) or mean aortic gradient of 30-50 mmHg in the
           presence of normal flow conditions. We already know how to treat patients with severe
           AS, symptomatic or not. On the contrary, in patients with moderate AS there is not a
           clear agreement on what to do to reduce the excess mortality (detailed below). Why do
           these patients die and what can we do to reduce mortality rates? 1.2. Originality of the
           proposed solution and the appropriateness of the objectives. There are already some
           progression factors in all spectrum of AS that have been highlighted (discussed below)
           and which could influence mortality in this patient subgroup, but none of the studies
           address exclusively to moderate AS. The majority of these studies have major
           limitations, are not prospective, and even if some are, the parameters followed do not
           cover the complete cardiological investigational tools (no 3D left ventricular (LV)
           ejection fraction (EF), no strain, no magnetic resonance imaging (MRI), etc.). As in any
           major disease, lots of studies that include moderate AS are contradictory on the same
           matter (see progression of AS). We aim to identify all clinical, biological, echo and
           imagistic parameters that predispose to increased progression rates in a prospective
           randomized trial which will include ONLY patients with moderate AS, with the
           investigational tools provided in 2012. Once those parameters are found, medical and
           interventional treatment could be implemented to decrease the mortality rates.

           But first, some data about survival and death in moderate AS. I would like to start by
           paraphrasing one of the most passionate researchers in the field of aortic stenosis, C.
           Otto (2): "even mild disease is important" (referring of course at the outcomes of
           patients with mild AS). Similarly, people with moderate AS/ aortic sclerosis, not even
           mentioning moderate to severe AS (3) have an increased death rate in comparison to
           age-matched healthy population. The same author reported in 1999 the results of a
           prospective study (4) with a follow-up (FU) at 5 years and she observed a cardiac death
           rate of 6.1% in general population (normal aortic valves), 10.1% in patients with aortic
           sclerosis and 19.6% in patients with AS. In 2004 Rosenhek et al. (5) found a cardiac
           death rate of 8.7% in a population with mean age of 67 years, with moderate AS at the
           initial examination. Even though the largest study (6) evaluating medical treatment in
           moderate AS reported a cardiac death rate of 6.0% (similar to general population), we
           consider this study not eloquent because there was a super-selected population enrolled
           (investigators ruled out the most important progression factors of AS: exclusion
           criteria included history of coronary artery disease (CAD), stroke and diabetes mellitus
           (DM)).

        2. Trials involving patients with moderate AS. In this presentation we will not review or
           discuss outcomes of severe AS, but ONLY outcomes of patients with MODERATE AS.

           The first step in our research was the identification of all studies involving moderate
           AS. We observed that there are few studies that included ONLY patients with moderate AS.
           At the opposite, the large majority of studies included moderate AS among all spectrum
           of AS patients (sclerosis, mild, moderate, severe- alone or combined). That is why we
           categorized all previous studies regarding moderate AS by the baseline inclusion
           criteria. We found 4 major groups of enrolled patients that we reviewed and discussed
           below: patients with mild to moderate AS (Table 1) (5-10), patients with moderate AS
           (Table 2)(11-12), patients with mild, moderate and severe AS (Table 3)(13-20) and
           patients with moderate to severe AS (Table 4)(21-27).

           Even though all essential data regarding moderate AS can be easily read in the tables
           (patient characteristics, progression of moderate AS, outcomes, survival, limitations
           and conclusions) and even though progression factors are summed-up below, of great
           importance are the results of some echo studies recently published on which I would like
           to briefly discuss. Monin et al. enrolled 107 patients with baseline peak velocity (PV)
           of 3.5 to 4.4 m/s (26), he concluded that female sex, PV and brain natriuretic peptide
           (BNP) at baseline were correlated with AS progression and developed a score to best
           stratify outcomes in these patients (see Table 4 for limitations). Marechaux et al. (27)
           included 135 patients with at least moderate AS (53% had severe AS), with normal stress
           test at baseline. Increased progression was present in those with resting mean gradient
           (MG) >35 mmHg and exercise-induced increase in MG >20 mmHg (see Table 4 for
           limitations). Two studies tried to clarify the role of strain in AS. One of the studies
           showed that strain gradually decreased as severity of AS increases and that global
           longitudinal strain (GLS) might be useful to assess subtle changes in LV function in
           patients with mild, moderate and severe AS (17). In the second study, Ng et al. (19)
           found that longitudinal, radial and circumferential strain and strain rate (SR)
           deteriorate with aortic valve disease progression. Important limitations of both studies
           are found in Table 3.

        3. Progression of AS. There is a wide variability in AS progression. Progression rates (for
           the PV) begin from 0.15±0.01 m/s/y in population without cardiovascular risk factors (6)
           and increase to 0.34±0.42 m/s/y in patients with CAD, reaching 0.45±0.38 m/s/y in
           patients with cardiovascular events (5).

           High progressors are those that have at least one abnormal parameter of the followings:
           echocardiography parameters: baseline PV (3, 12, 5, 10, 16, 20, 26), baseline peak
           gradient (24), mean gradient (3), rate of increase in PV (3, 20), moderate to severe
           aortic valve calcification on echo (5, 12), LV hypertrophy (27), resting MG >35 mmHg
           (27), exercise-induced increase in MG >20 mmHg (27), E velocity (16), bicuspid aortic
           valve (16); clinical predictors: CAD (5, 21), age (>80 years-8, 12, 18, 20, >64
           years-21, >65years-27), diabetes (14, 27), metabolic syndrome (MS) (24), dialysis (28,
           29), increased BMI (7), functional status (3), history of smoking (7, 30), systolic
           blood pressure (SBP) (18, 30), male gender (24, 30), female gender (26); and biological
           parameters: parathyroid hormone (PTH) level (18), BNP at baseline (26), high lipoprotein
           (a) (Lp(a)) and low density lipoprotein (LDL) cholesterol levels (30).

           No influence on AS progression were treatment with simvastatin and ezetimibe (6),
           elprenone (25) or rosuvastatin (9) and statins (14).

           Slower progression was observed after osteoporosis (11) and bisphosphonate treatment
           (15), but studies were either too small, retrospective (11, 15) or biased (11).
           Geographical differences are evident in two papers which show that Korean patients
           progress slower than western population (12, 16).

           Data regarding the role of C-reactive protein in AS progression are controversial (10,
           13).

           We did not discuss the old studies or small series of patients with AS, some in the era
           of cardiac catheterizations (31-36), some in the early echo decades (37-41). Their
           capability to address this subject was limited by a retrospective design in most cases,
           potential selection bias, limited clinical, functional, or exercise data, the
           availability of only two data points per patient, lack of factors that predict the rate
           of hemodynamic progression and clinical outcome.

        4. Incidence of AS. Degenerative aortic valve disease evolves slowly from aortic sclerosis
           to aortic stenosis. Aortic sclerosis and stenosis are found in about 29% and 2-9%
           respectively in adults older than 65 years (4). In 5,201 subjects > 65 years, aortic
           valve sclerosis was present in 26% and AS in 2% of the entire study cohort; in subjects
           >75 years of age, sclerosis was present in 37% and stenosis in 2.6% (30). The prevalence
           of critical AS was 2.9% in the group 75 to 86 years of age in another study (42). In an
           observational study (43) which enrolled 953 subjects (aged 25-74 years), the overall
           prevalence of degenerative aortic valve disease (defined as the presence of valvular
           sclerosis, calcification, or thickening on echocardiographical examination) was 28%. The
           prevalence of degenerative aortic valve disease by age groups was the following: 7%
           (35-44 years), 19% (45-54), 30% (55-64), 38% (65-74) and 64% (75-84). There were no
           significant differences between men and women.

      Clinical factors associated with AS are similar to those associated with CAD (3, 44). Even
      though several small non-randomized studies (45, 46-49) suggested a beneficial effect of
      statins, three prospective randomized studies did not find any effect of lipid-lowering
      therapy on the progression of aortic-valve stenosis.(6, 10, 50).
    


Study Type

Observational


Primary Outcome

occurrence of major adverse cardiac events (MACE) defined by the followings: death, aortic valve replacement (AVR) and myocardial infarction (MI).

Secondary Outcome

 TIME TO SYMPTOMS (angina, dyspnea, syncope) at stress echocardiography

Condition

Aortic Stenosis


Study Arms / Comparison Groups

 Asymptomatic group
Description:  one hundred patients with a negative exercise stress echo for symptoms/ECG/wall motion abnormalities (WMA), negative spirometry test for pulmonary disease, without known CAD or other valvular diseases, in sinus rhythm and with a LVEF>55%

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

200

Start Date

July 2012

Completion Date

June 2016

Primary Completion Date

January 2016

Eligibility Criteria

        Inclusion Criteria:

          -  age 21 years;

          -  native aortic valve leaflet thickening with reduced systolic opening on
             two-dimensional echocardiography and an aortic jet velocity at rest between 2.8 and
             3.1 m/s or a valve area calculated by the continuity equation of 1.7 to 1.5 cm2,
             evaluated at a heart rate between 60 and 90/ minute and at a systolic arterial
             pressure of 120-140mmHg at baseline;

          -  LVEF > 55% (calculated by modified Simpson formula).

        Exclusion Criteria:

          -  positive stress test (symptoms including dyspnoea, angina, syncope, ECG pathological
             changes, WMA);

          -  positive pulmonary disease (spirometry);

          -  heart failure;

          -  LVEF < 55%;

          -  moderate/severe aortic or mitral regurgitation or mitral stenosis, subvalvular or
             supravalvular AS, dynamic subaortic obstruction;

          -  CAD (history of MI or coronary artery stenosis on coronary angiography);

          -  active endocarditis;

          -  rhythm other than sinus rhythm;

          -  severe uncontrolled risk factors for CAD:

               -  uncontrolled DM,

               -  uncontrolled hypertension (SBP > 180mmHg),

               -  refuse to discontinue smoking,

               -  persistent hypercholesterolemia under treatment (total cholesterol > 240mg/dl);

          -  glomerular filtration rate < 30% or patient requiring dialysis;

          -  patient refusal; survival expectancy < 2 years;

          -  inability to perform physical exercise;

          -  suboptimal echo window;

          -  different types of echo machines.
      

Gender

All

Ages

50 Years - 90 Years

Accepts Healthy Volunteers

No

Contacts

ALEXANDRU N MISCHIE, MD, , 

Location Countries

Romania

Location Countries

Romania

Administrative Informations


NCT ID

NCT01575249

Organization ID

The ENIGMAS trial


Responsible Party

Principal Investigator

Study Sponsor

Carol Davila University of Medicine and Pharmacy


Study Sponsor

ALEXANDRU N MISCHIE, MD, Principal Investigator, BAGDASAR ARSENI EMERGENCY HOSPITAL


Verification Date

April 2012