Ramipril Versus Carvedilol in Duchenne and Becker Patients
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|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
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|Condition or disease||Intervention/treatment||Phase|
|Duchenne Muscular Dystrophy Becker Muscular Dystrophy||Drug: carvedilol Drug: ramipril||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||194 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
carvedilol vs ramipril
Other Name: ACE-inhibitor
carvedilol vs ramipril
Other Name: Beta-Blocker
- 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 ]
- 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 ]
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|Ages Eligible for Study:||2 Years to 45 Years (Child, Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||Yes|
- Immunohystochemical and molecular diagnosis of Duchenne and Becker muscular dystrophy.
- Not evidence of clinical cardiomyopathy,normal 2D-echocardiography with normal systolic,WMSI = 1) and diastolic function.
- DMD patients treated with steroid therapy.
- All DMD and BMD patients are not treated with cardiological therapy (ACE-inhibitors, ARBs or Beta-Blockers).
- 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.
- Failure to obtain informed consent from patients, parents or guardians.
- 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).
- 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.
- In BMD patients exclusion criteria will be also hypertension and valvular heart disease other than trivial.
- DMD and BMD patients requiring ventilatory (non-invasive or invasive) assistance.
- Presence of systolic and/or diastolic dysfunction detected by 2D-Echocardiography.
- Presence of any contraindications to CMR (including any history of claustrophobia).
- Patients under the age of 2 years.
- Renal failure, even mild.
- 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).
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
|Contact: Vincenzo Giglio, MD, PhDemail@example.com|
|Contact: Fortunato Mangiola, MDfirstname.lastname@example.org|
|Unione Italiana lotta Distrofia Muscolare||Recruiting|
|Rome, Italy, 00167|
|Contact: Vincenzo Giglio, MD, PhD 39-6-6604881 email@example.com|
|Contact: Fortunato Mangiola, MD 39-6-6604881 firstname.lastname@example.org|
|Principal Investigator: Vincenzo Giglio, MD, PhD|
|Principal Investigator:||Vincenzo Giglio, MD, PhD||Uildm, Rome|
|Responsible Party:||Vincenzo Giglio MD, PhD, Uildm of Rome|
|Other Study ID Numbers:||
|First Posted:||January 9, 2009 Key Record Dates|
|Last Update Posted:||January 28, 2016|
|Last Verified:||January 2009|
Becker muscular dystrophy
cardiac magnetic resonance
ultrasound tissue characterization
Muscular Dystrophy, Duchenne
Muscular Disorders, Atrophic
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Angiotensin-Converting Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Adrenergic alpha-1 Receptor Antagonists