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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01917149 |
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Date of registration:
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30/07/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Supramaximal Titrated Inhibition of RAAS in Dilated Cardiomyopathy
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Scientific title:
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Efficacy and Safety Study of Supramaximal Titrated Inhibition of RAAS in Idiopathic Dilated Cardiomyopathy |
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Date of first enrolment:
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March 2005 |
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Target sample size:
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480 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01917149 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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China
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Contacts
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Name:
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Zheng He, MD, phD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Cardiology, Xijing Hospital, Fourth Military Medical University |
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Name:
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Qiujun Yu, MD, phD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Cardiology, Xijing Hospital, Fourth Military Medical University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of dilated cardiomyopathy
- Left ventricular ejection fraction < 35%
- NYHA Functional classes of II-IV
- Symptomatic but not rapidly deteriorating 1 month before enrollment
- Signed informed consent
Exclusion Criteria:
- Contradictions and intolerance of the studied drugs:
- supine systolic arterial blood pressure < 90 mmHg,
- renal artery stenosis >50%,
- pregnancy or lactation,
- impaired renal function (estimated glomerular filtration rate < 60
ml/min/1.73m2,
- impaired liver function (total bilirubin >2 times upper limit of normal,
- serum aspartate AST or alanine ALT >3 times the upper limit of normal),
- hemoglobin less than 8 mg/dl, hyperkalaemia (serum potassium >5.5mmol/l),
- obstructive lung disease,
- advanced atrioventricular block,
- any co-morbidity with impact on survival, and
- known intolerance to benazepril, valsartan and metoprolol succinate;
- HF secondary to a known cause:
- coronary artery disease based on coronary angiography (=50% stenosis in =1 of
the major coronary arteries) and/or a history of myocardial infarction or angina
pectoris,
- acute or subacute stage of myocarditis,
- primary valve disease,
- diabetes mellitus,
- excessive use of alcohol or illicit drugs;
- Expected or performed cardiac resynchronization therapy and heart transplantation.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Dilated Cardiomyopathy
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Intervention(s)
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Drug: Valsartan
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Drug: Benazepril
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Drug: Metoprolol
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Primary Outcome(s)
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All cause death or admission for heart failure
[Time Frame: 48 months after enrollment]
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Secondary Outcome(s)
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Left-ventricular end-diastolic diameter
[Time Frame: 6, 12 , 24 and 36 months after enrollment]
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Changes in NYHA functional class
[Time Frame: 6,12, 24 and 36 months after enrollment]
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Left-ventricular ejection fraction
[Time Frame: 6,12, 24 and 36 months after enrollment]
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Secondary ID(s)
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SIRAAS-DC
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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