Neurohormonal Parameters in Hypertrophic Cardiomyopathies (REEF-CMH)
Primary Purpose
1- Primary (Sarcomeric) Hypertrophic Cardiomyopathy, 2- Obstructive Hypertrophic Cardiomyopathy, 3- Non Obstructive Hypertrophic Cardiomyopathy
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood sample collection
Sponsored by
About this trial
This is an interventional diagnostic trial for 1- Primary (Sarcomeric) Hypertrophic Cardiomyopathy focused on measuring 1- Hypertrophic cardiomyopathy, 2- BNP, 3- NT-proBNP, 4- Neurohormons
Eligibility 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)
Sites / Locations
- Hôpital Européen Georges Pompidou
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
single group - consecutive patients
Arm Description
Outcomes
Primary Outcome Measures
Plasmatic Neurohormonal measures: BNP - NT ProBNP - Troponine
Secondary Outcome Measures
Full Information
NCT ID
NCT01729702
First Posted
November 15, 2012
Last Updated
March 25, 2014
Sponsor
French Cardiology Society
1. Study Identification
Unique Protocol Identification Number
NCT01729702
Brief Title
Neurohormonal Parameters in Hypertrophic Cardiomyopathies
Acronym
REEF-CMH
Official Title
Evaluation at Rest and Exercise of Clinical, Ultrasonic and Neurohormonal Parameters in Hypertrophic Cardiomyopathies
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
French Cardiology Society
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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)
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
1- Primary (Sarcomeric) Hypertrophic Cardiomyopathy, 2- Obstructive Hypertrophic Cardiomyopathy, 3- Non Obstructive Hypertrophic Cardiomyopathy
Keywords
1- Hypertrophic cardiomyopathy, 2- BNP, 3- NT-proBNP, 4- Neurohormons
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
131 (Actual)
8. Arms, Groups, and Interventions
Arm Title
single group - consecutive patients
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
blood sample collection
Primary Outcome Measure Information:
Title
Plasmatic Neurohormonal measures: BNP - NT ProBNP - Troponine
Time Frame
Day 1 at rest and during exercise
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Hagège, MD-PhD
Organizational Affiliation
HEGP - Paris
Official's Role
Study Chair
Facility Information:
Facility Name
Hôpital Européen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
12. IPD Sharing Statement
Learn more about this trial
Neurohormonal Parameters in Hypertrophic Cardiomyopathies
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