NCT01729702

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 20, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

March 26, 2014

Status Verified

March 1, 2014

Enrollment Period

4.7 years

First QC Date

November 15, 2012

Last Update Submit

March 25, 2014

Conditions

1- Primary (Sarcomeric) Hypertrophic Cardiomyopathy2- Obstructive Hypertrophic Cardiomyopathy3- Non Obstructive Hypertrophic Cardiomyopathy

Keywords

1- Hypertrophic cardiomyopathy2- BNP3- NT-proBNP4- Neurohormons

Outcome Measures

Primary Outcomes (1)

  • Plasmatic Neurohormonal measures: BNP - NT ProBNP - Troponine

    Day 1 at rest and during exercise

Study Arms (1)

single group - consecutive patients

OTHER
Other: blood sample collection

Interventions

blood sample collectionOTHER
single group - consecutive patients

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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

You may not qualify if:

  • \- 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve Diseases

Study Officials

  • Albert Hagège, MD-PhD

    HEGP - Paris

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2012

First Posted

November 20, 2012

Study Start

April 1, 2009

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

March 26, 2014

Record last verified: 2014-03

Locations

FR(1)