Heart Failure Clinical Trial
— NEBIDYSOfficial title:
A Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Examine the Effect of Nebivolol, a Beta-Blockade Drug, for the Prevention of Ventricular Systolic Dysfunction in Patients With Duchenne Muscular Dystrophy
Verified date | September 2021 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective is to determine whether nebivolol, a beta-blockade drug, can prevent the development of heart disease in patients with Duchenne muscular dystrophy aged 10 to 15 year-old.
Status | Completed |
Enrollment | 51 |
Est. completion date | July 20, 2021 |
Est. primary completion date | July 20, 2021 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 10 Years to 15 Years |
Eligibility | Inclusion Criteria: - Duchenne muscular dystrophy genetically proven - Age between 10 and 15 years - Left ventricular ejection fraction assessed by radionuclide angiography or echocardiography =50% and measured within 3 months - Systolic blood pressure =80 mmHg - Diastolic blood pressure =70 mmHg Exclusion Criteria: - Heart rate <50 bpm - 2nd or 3rd degree atrioventricular blocks, sinus node dysfunction - Asthma or bronchospasm - Severe peripheral circulatory disease - Hypersensitivity to nebivolol or excipients - Metabolic acidosis - Blood urea >7 mmol/l - Liver transaminases enzymes >6 fold the upper limit of normal - Formal indication for beta-blockade treatment - Cardiac treatments except angiotensin-converting enzyme inhibitors - Participation to another clinical trial within 3 months |
Country | Name | City | State |
---|---|---|---|
France | Armand Trousseau Hospital | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | Association Française contre les Myopathies (AFM), Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Left ventricular systolic dysfunction | Development of left ventricular systolic dysfunction with an ejection fraction < 45% | at 5 years | |
Secondary | Right ventricular ejection fraction | Right ventricular ejection fraction assessed by radionuclide angiography or echocardiography | at 5 years | |
Secondary | NT-ProBNP | NT-ProBNP | at 1, 2, 3, 4, and 5 years | |
Secondary | Left ventricular dysfunction | Development of left ventricular dysfunction | at 10 years | |
Secondary | Hospitalizations | hospitalizations for heart failure | at 10 years | |
Secondary | Mortality | Cardiovascular mortality | at 10 years ((5-years open label extension) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
Recruiting |
NCT05196659 -
Collaborative Quality Improvement (C-QIP) Study
|
N/A | |
Recruiting |
NCT05650307 -
CV Imaging of Metabolic Interventions
|
||
Active, not recruiting |
NCT05896904 -
Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction
|
N/A | |
Completed |
NCT05077293 -
Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
|
||
Recruiting |
NCT05631275 -
The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
|
||
Enrolling by invitation |
NCT05564572 -
Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology
|
N/A | |
Enrolling by invitation |
NCT05009706 -
Self-care in Older Frail Persons With Heart Failure Intervention
|
N/A | |
Recruiting |
NCT04177199 -
What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
|
||
Terminated |
NCT03615469 -
Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY)
|
N/A | |
Recruiting |
NCT06340048 -
Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure
|
Phase 1/Phase 2 | |
Recruiting |
NCT05679713 -
Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
|
||
Completed |
NCT04254328 -
The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure
|
N/A | |
Completed |
NCT03549169 -
Decision Making for the Management the Symptoms in Adults of Heart Failure
|
N/A | |
Recruiting |
NCT05572814 -
Transform: Teaching, Technology, and Teams
|
N/A | |
Enrolling by invitation |
NCT05538611 -
Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
|
||
Recruiting |
NCT04262830 -
Cancer Therapy Effects on the Heart
|
||
Completed |
NCT06026683 -
Conduction System Stimulation to Avoid Left Ventricle Dysfunction
|
N/A | |
Withdrawn |
NCT03091998 -
Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support
|
Phase 1 | |
Recruiting |
NCT05564689 -
Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy
|