Neurohormonal Parameters in Hypertrophic Cardiomyopathies

1- Primary (Sarcomeric) Hypertrophic Cardiomyopathy Clinical Trial

— REEF-CMH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01729702
• Other study ID #: 2008-08
• Status: Completed
• Phase: N/A
• First received: November 15, 2012
• Last updated: March 25, 2014
• Start date: April 2009
• Est. completion date: December 2013

Study information

• Verified date: March 2014
• Source: French Cardiology Society
• Contact: n/a
• Is FDA regulated: No
• Health authority: France:Agence Nationale de Sécurité des Médicaments
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• 1- Primary (Sarcomeric) Hypertrophic Cardiomyopathy
• 2- Obstructive Hypertrophic Cardiomyopathy
• 3- Non Obstructive Hypertrophic Cardiomyopathy
• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophy

Intervention

Other:
• blood sample collection

Locations

Country	Name	City	State
France	Hôpital Européen Georges Pompidou	Paris

Sponsors (1)

Lead Sponsor	Collaborator
French Cardiology Society

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasmatic Neurohormonal measures: BNP - NT ProBNP - Troponine		Day 1 at rest and during exercise	No