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Ramipril Versus Carvedilol in Duchenne and Becker Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2009 by Catholic University, Italy.
Recruitment status was:  Recruiting
Information provided by:
Catholic University, Italy Identifier:
First received: January 8, 2009
Last updated: January 27, 2016
Last verified: January 2009
Data on preventive therapy in Duchenne muscular dystrophy (DMD) and Becker muscular dystrophy (BMD) affected individuals without cardiac involvement are very limited and currently lacking regard both ACE-inhibitors and Beta-Blockers in Becker Muscular Dystrophy and for the latter even in Duchenne Muscular Dystrophy patients. Thus, the study aim is to compare the efficacy of carvedilol vs ramipril on myocardial tissue properties and heart function, performing CMR and myocardial Ultrasound Tissue Characterisation analysis.

Condition Intervention Phase
Duchenne Muscular Dystrophy
Becker Muscular Dystrophy
Drug: carvedilol
Drug: ramipril
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effects of Cardioprotective Therapy, Carvedilol vs Ramipril, in Patients Affected by Duchenne and Becker Muscular Dystrophy. Clinical Significance and Prognostic Value of Cardiac Magnetic Resonance Study.

Resource links provided by NLM:

Further study details as provided by Catholic University, Italy:

Primary Outcome Measures:
  • Left ventricular Ejection Fraction, systolic and diastolic left ventricular volumes and LGE (as a quantitative measure) detected by MRI and myocardial Ultrasound Tissue Characterisation data by Echocardiography. [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Prevalence of LGE in DMD and BMD patients,the effects of pharmacological therapy both on LGE evolution and myocardial UTC analysis. [ Time Frame: 1 year ]

Estimated Enrollment: 194
Study Start Date: December 2008
Estimated Study Completion Date: December 2016
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ramipril Drug: ramipril
carvedilol vs ramipril
Other Name: ACE-inhibitor
Experimental: Carvedilol Drug: carvedilol
carvedilol vs ramipril
Other Name: Beta-Blocker

Detailed Description:
This protocol represent an open randomized and prospective trial, designed to answer the specific question regarding the role of the cardioprotective therapy in Duchenne Muscular Dystrophy and Becker Muscular Dystrophy patients. In this light, CMR could provide relevant data, reinforcing the scientific background, to start early (particularly in BMD patients in whom this is still a debated question) a cardioprotective treatment with carvedilol or ramipril.Finally,this clinical trial will clarify whether a preventive therapy may be helpful on the clinical outcome, both in reducing myocardial fibrosis and preventing the progression towards the cardiomyopathy.

Ages Eligible for Study:   2 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Immunohystochemical and molecular diagnosis of Duchenne and Becker muscular dystrophy.
  2. Not evidence of clinical cardiomyopathy,normal 2D-echocardiography with normal systolic,WMSI = 1) and diastolic function.
  3. DMD patients treated with steroid therapy.
  4. All DMD and BMD patients are not treated with cardiological therapy (ACE-inhibitors, ARBs or Beta-Blockers).
  5. Written informed consent to study participation (with serial visit, CMR and echocardiographic study) is required from all patients themselves, as well as their parent or guardian and healthy-control subjects.

Exclusion Criteria:

  1. Failure to obtain informed consent from patients, parents or guardians.
  2. Any controindications to carvedilol or ramipril treatment (bronchial asthma, diabetes, any degree of renal failure (all patients are required to have a normal creatinine level and clearance).
  3. in BMD patients ECG changes suggestive of ischemic heart disease, left bundle-branch block, atrial flutter/fibrillation, ventricular arrhythmias, any degree of atrioventricular block and left ventricular (LV) hypertrophy. Aspecific ST changes will be not considered as electrocardiographic exclusion criteria both in DMD and BMD patients.
  4. In BMD patients exclusion criteria will be also hypertension and valvular heart disease other than trivial.
  5. DMD and BMD patients requiring ventilatory (non-invasive or invasive) assistance.
  6. Presence of systolic and/or diastolic dysfunction detected by 2D-Echocardiography.
  7. Presence of any contraindications to CMR (including any history of claustrophobia).
  8. Patients under the age of 2 years.
  9. Renal failure, even mild.
  10. Patient unable or unwilling to attend the follow-up and tests, in the opinion of local study principal investigator, (children not willing to perform CMR will not be enrolled).
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Please refer to this study by its identifier: NCT00819845

Contact: Vincenzo Giglio, MD, PhD 39-6-6604881
Contact: Fortunato Mangiola, MD 39-6-6604881

Unione Italiana lotta Distrofia Muscolare Recruiting
Rome, Italy, 00167
Contact: Vincenzo Giglio, MD, PhD    39-6-6604881   
Contact: Fortunato Mangiola, MD    39-6-6604881   
Principal Investigator: Vincenzo Giglio, MD, PhD         
Sponsors and Collaborators
Catholic University, Italy
Principal Investigator: Vincenzo Giglio, MD, PhD Uildm, Rome
  More Information

Responsible Party: Vincenzo Giglio MD, PhD, Uildm of Rome Identifier: NCT00819845     History of Changes
Other Study ID Numbers: Uildm Rome
Study First Received: January 8, 2009
Last Updated: January 27, 2016

Keywords provided by Catholic University, Italy:
Becker muscular dystrophy
cardioprotective therapy
cardiac magnetic resonance
ultrasound tissue characterization

Additional relevant MeSH terms:
Muscular Dystrophies
Muscular Dystrophy, Duchenne
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors processed this record on April 28, 2017