Neurohormonal Parameters in Hypertrophic Cardiomyopathies

NCT ID: NCT01729702

Last Updated: 2014-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2013-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

1- Primary (Sarcomeric) Hypertrophic Cardiomyopathy 2- Obstructive Hypertrophic Cardiomyopathy 3- Non Obstructive Hypertrophic Cardiomyopathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

single group - consecutive patients

Group Type OTHER

blood sample collection

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

blood sample collection

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

French Cardiology Society

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Albert Hagège, MD-PhD

Role: STUDY_CHAIR

HEGP - Paris

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hôpital Européen Georges Pompidou

Paris, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2008-08

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Diagnosis of HCM With AI-ECG
NCT06287892 RECRUITING
The Echodynamic Approach
NCT06859047 RECRUITING