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Completed

NCT Number: NCT01729702

Neurohormonal Parameters in Hypertrophic Cardiomyopathies

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)

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Key information

Conditions

1- Primary (Sarcomeric) Hypertrophic Cardiomyopathy 2- Obstructive Hypertrophic Cardiomyopathy 3- Non Obstructive Hypertrophic Cardiomyopathy Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Européen Georges Pompidou

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Blood Sample Collection

Other

Primary outcomes

  1. Plasmatic Neurohormonal measures: BNP - NT ProBNP - Troponine

    Time frame: Day 1 at rest and during exercise

Sponsors and collaborators

Lead sponsor

French Cardiology Society

Other

Registry information

Official study title

Evaluation at Rest and Exercise of Clinical, Ultrasonic and Neurohormonal Parameters in Hypertrophic Cardiomyopathies

Acronym: REEF-CMH

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Nov 20, 2012
Registry last updated
Mar 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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