Trial record 2 of 45 for:
Open Studies | "Muscular Dystrophy, Duchenne"
Ramipril Versus Carvedilol in Duchenne and Becker Patients
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Catholic University, Italy.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Catholic University, Italy
Information provided by:
Catholic University, Italy
ClinicalTrials.gov Identifier:
NCT00819845
First received: January 8, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
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Purpose
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 Endpoint Classification: Efficacy Study 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:
Genetics Home Reference related topics:
Duchenne and Becker muscular dystrophy
MedlinePlus related topics:
Muscular Dystrophy
U.S. FDA Resources
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 194 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | December 2011 |
| Estimated 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.
Eligibility| Ages Eligible for Study: | 2 Years to 45 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00819845
Contacts
| Contact: Vincenzo Giglio, MD, PhD | 39-6-6604881 | giglio.echo@libero.it |
| Contact: Fortunato Mangiola, MD | 39-6-6604881 | fortunato.mangiola@uildmlazio.org |
Locations
| 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
| Principal Investigator: | Vincenzo Giglio, MD, PhD | Uildm, Rome |
More Information
No publications provided
| Responsible Party: | Vincenzo Giglio MD, PhD, Uildm of Rome |
| ClinicalTrials.gov Identifier: | NCT00819845 History of Changes |
| Other Study ID Numbers: | Uildm Rome |
| Study First Received: | January 8, 2009 |
| Last Updated: | January 8, 2009 |
| Health Authority: | Italy: The Italian Medicines Agency |
Keywords provided by Catholic University, Italy:
|
Duchenne Becker muscular dystrophy cardioprotective therapy cardiac magnetic resonance ultrasound tissue characterization |
Additional relevant MeSH terms:
|
Muscular Dystrophy, Duchenne Muscular Dystrophies Muscular Disorders, Atrophic Muscular Diseases Musculoskeletal Diseases Neuromuscular Diseases Nervous System Diseases Genetic Diseases, X-Linked Genetic Diseases, Inborn Angiotensin-Converting Enzyme Inhibitors Ramipril Carvedilol Protease Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Physiological Effects of Drugs Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Vasodilator Agents Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists |
ClinicalTrials.gov processed this record on June 17, 2013