Status:
COMPLETED
Supramaximal Titrated Inhibition of RAAS in Dilated Cardiomyopathy
Lead Sponsor:
Xijing Hospital
Conditions:
Dilated Cardiomyopathy
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
Dilated cardiomyopathy (DCM) is a poorly understood cause of systolic heart failure and is the most common indication for heart transplantation worldwide. Despite advances in medical and device therap...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT01917149
Start Date
March 1 2005
End Date
December 1 2013
Last Update
May 19 2014
Active Locations (1)
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1
Xijing Hospital, Department of Cardiology
Xi'an, China, 710032