search
Back to results

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
French Cardiology Society
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 15, 2012
Last Updated
March 25, 2014
Sponsor
French Cardiology Society
search

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

We'll reach out to this number within 24 hrs