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Ramipril Versus Carvedilol in Duchenne and Becker Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00819845
Recruitment Status : Unknown
Verified January 2009 by Catholic University, Italy.
Recruitment status was:  Recruiting
First Posted : January 9, 2009
Last Update Posted : January 28, 2016
Sponsor:
Information provided by:
Catholic University, Italy

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Duchenne Muscular Dystrophy Becker Muscular Dystrophy Drug: carvedilol Drug: ramipril Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 194 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : December 2008
Actual Primary Completion Date : June 2009
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Ramipril Drug: ramipril
carvedilol vs ramipril
Other Name: ACE-inhibitor
Experimental: Carvedilol Drug: carvedilol
carvedilol vs ramipril
Other Name: Beta-Blocker


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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 ]

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

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).
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00819845


Contacts
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Contact: Vincenzo Giglio, MD, PhD 39-6-6604881 giglio.echo@libero.it
Contact: Fortunato Mangiola, MD 39-6-6604881 fortunato.mangiola@uildmlazio.org

Locations
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Italy
Unione Italiana lotta Distrofia Muscolare Recruiting
Rome, Italy, 00167
Contact: Vincenzo Giglio, MD, PhD    39-6-6604881    giglio.echo@libero.it   
Contact: Fortunato Mangiola, MD    39-6-6604881    fortunato.mangiola@uildmlazio.org   
Principal Investigator: Vincenzo Giglio, MD, PhD         
Sponsors and Collaborators
Catholic University, Italy
Investigators
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Principal Investigator: Vincenzo Giglio, MD, PhD Uildm, Rome
More Information
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Responsible Party: Vincenzo Giglio MD, PhD, Uildm of Rome
ClinicalTrials.gov Identifier: NCT00819845    
Other Study ID Numbers: Uildm Rome
First Posted: January 9, 2009    Key Record Dates
Last Update Posted: January 28, 2016
Last Verified: January 2009
Keywords provided by Catholic University, Italy:
Duchenne
Becker muscular dystrophy
cardioprotective therapy
cardiac magnetic resonance
ultrasound tissue characterization
Additional relevant MeSH terms:
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Muscular Dystrophies
Muscular Dystrophy, Duchenne
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Carvedilol
Ramipril
Angiotensin-Converting Enzyme Inhibitors
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Antioxidants
Protective Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Protease Inhibitors
Enzyme Inhibitors