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Neurohormonal Parameters in Hypertrophic Cardiomyopathies (REEF-CMH)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01729702
First Posted: November 20, 2012
Last Update Posted: March 26, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
French Cardiology Society
  Purpose
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)

Condition Intervention
1- Primary (Sarcomeric) Hypertrophic Cardiomyopathy 2- Obstructive Hypertrophic Cardiomyopathy 3- Non Obstructive Hypertrophic Cardiomyopathy Other: blood sample collection

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation at Rest and Exercise of Clinical, Ultrasonic and Neurohormonal Parameters in Hypertrophic Cardiomyopathies

Resource links provided by NLM:


Further study details as provided by French Cardiology Society:

Primary Outcome Measures:
  • Plasmatic Neurohormonal measures: BNP - NT ProBNP - Troponine [ Time Frame: Day 1 at rest and during exercise ]

Enrollment: 131
Study Start Date: April 2009
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
single group - consecutive patients Other: blood sample collection

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01729702


Locations
France
Hôpital Européen Georges Pompidou
Paris, France, 75015
Sponsors and Collaborators
French Cardiology Society
Investigators
Study Chair: Albert Hagège, MD-PhD HEGP - Paris
  More Information

Responsible Party: French Cardiology Society
ClinicalTrials.gov Identifier: NCT01729702     History of Changes
Other Study ID Numbers: 2008-08
First Submitted: November 15, 2012
First Posted: November 20, 2012
Last Update Posted: March 26, 2014
Last Verified: March 2014

Keywords provided by French Cardiology Society:
1- Hypertrophic cardiomyopathy
2- BNP
3- NT-proBNP
4- Neurohormons

Additional relevant MeSH terms:
Cardiomyopathies
Hypertrophy
Cardiomyopathy, Hypertrophic
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases


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