Neurohormonal Parameters in Hypertrophic Cardiomyopathies

Not Applicable

Completed

• Conditions: 1- Primary (Sarcomeric) Hypertrophic Cardiomyopathy; 2- Obstructive Hypertrophic Cardiomyopathy; 3- Non Obstructive Hypertrophic Cardiomyopathy
• Interventions: Other: blood sample collection

• Registration Number: NCT01729702
• Lead Sponsor: French Cardiology Society

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 Timeline

• Study Start: 2009-04
• Study First Submitted: 2012-11-15
• Study First Submitted QC: 2012-11-15
• Study First Posted: 2012-11-20
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-25
• Last Update Posted: 2014-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single group - consecutive patients	blood sample collection	-

Primary Outcome Measures

Name	Time	Method
Plasmatic Neurohormonal measures: BNP - NT ProBNP - Troponine	Day 1 at rest and during exercise

Trial Locations

Locations (1)

Hôpital Européen Georges Pompidou; 🇫🇷 Paris, France