Neurohormonal Parameters in Hypertrophic Cardiomyopathies (REEF-CMH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
French Cardiology Society
ClinicalTrials.gov Identifier:
NCT01729702
First received: November 15, 2012
Last updated: March 25, 2014
Last verified: March 2014
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: French Cardiology Society
ClinicalTrials.gov Identifier: NCT01729702     History of Changes
Other Study ID Numbers: 2008-08
Study First Received: November 15, 2012
Last Updated: March 25, 2014
Health Authority: France:Agence Nationale de Sécurité des Médicaments

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

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

ClinicalTrials.gov processed this record on October 23, 2014