NCT01729702CompletedNot Applicable
Evaluation at Rest and Exercise of Clinical, Ultrasonic and Neurohormonal Parameters in Hypertrophic Cardiomyopathies
French Cardiology Society1 site in 1 country131 target enrollmentStarted: April 1, 2009Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 131
- Locations
- 1
- Primary Endpoint
- Plasmatic Neurohormonal measures: BNP - NT ProBNP - Troponine
Study Overview
Brief Summary
The primary purpose of this study is to demonstrate that changes in plasma levels of circulating neurohormones (mainly BNP and NT-proBNP), measured at rest and post-exercise correlate with exercise functional limitation (assessed by exercise peak VO2) and exercise ultrasonic parameters (as left ventricular filling, obstruction, and mitral regurgitation)
Detailed Description
The secondary purposes are to study the kinetics of secretions of natriuretic peptides, and their relationships with extent of MRI myocardial fibrosis with the degree of exercise functional limitation.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •- Age 18 to 75 years
- •Primary (sarcomeric) hypertrophic cardiomyopathy, obstructive or non obstructive, with studies of exercise peak oxygen consumption and cardiac MRI with gadolinium late-enhancement
- •Informed consent
- •Patient with a social insurance Patient at rest
- •- Age 18 to 75 years
- •Primary (sarcomeric) hypertrophic cardiomyopathy, obstructive or non obstructive
- •Informed consent
- •Patient with a social insurance
Exclusion Criteria
- •- Insufficient echogenicity
- •Permanent atrial fibrillation
- •Complete BBB on the ECG
- •LVEF < 35 %
- •Previous septal ablation (surgical or percutaneous)
- •Simultaneous participation to another biomedical research
- •If exercise needed:
- •contraindication to exercise : hemodynamic instability, uncontrolled high blood pressure (>220/120 mmHg), severe aortic stenosis
- •Inability to exercise (muscular, pulmonary, elderly patient)
Arms & Interventions
single group - consecutive patients
Other
Intervention: blood sample collection (Other)
Outcomes
Primary Outcomes
Plasmatic Neurohormonal measures: BNP - NT ProBNP - Troponine
Time Frame: Day 1 at rest and during exercise
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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