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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
November 15, 2012
November 20, 2012
March 26, 2014
April 2009
December 2013   (Final data collection date for primary outcome measure)
Plasmatic Neurohormonal measures: BNP - NT ProBNP - Troponine [ Time Frame: Day 1 at rest and during exercise ]
Same as current
Complete list of historical versions of study NCT01729702 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Neurohormonal Parameters in Hypertrophic Cardiomyopathies
Evaluation at Rest and Exercise of Clinical, Ultrasonic and 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)
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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • 1- Primary (Sarcomeric) Hypertrophic Cardiomyopathy
  • 2- Obstructive Hypertrophic Cardiomyopathy
  • 3- Non Obstructive Hypertrophic Cardiomyopathy
Other: blood sample collection
single group - consecutive patients
Intervention: Other: blood sample collection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
131
December 2013
December 2013   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01729702
2008-08
No
Not Provided
Not Provided
French Cardiology Society
French Cardiology Society
Not Provided
Study Chair: Albert Hagège, MD-PhD HEGP - Paris
French Cardiology Society
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP