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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.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01917149
Date of registration: 30/07/2013
Prospective Registration: No
Primary sponsor: Xijing Hospital
Public title: Supramaximal Titrated Inhibition of RAAS in Dilated Cardiomyopathy
Scientific title: Efficacy and Safety Study of Supramaximal Titrated Inhibition of RAAS in Idiopathic Dilated Cardiomyopathy
Date of first enrolment: March 2005
Target sample size: 480
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT01917149
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment  
Phase:  Phase 4
Countries of recruitment
China
Contacts
Name:     Qiujun Yu, MD, phD
Address: 
Telephone:
Email:
Affiliation:  Department of Cardiology, Xijing Hospital, Fourth Military Medical University
Name:     Zheng He, MD, phD
Address: 
Telephone:
Email:
Affiliation:  Department of Cardiology, Xijing Hospital, Fourth Military Medical University
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Dilated Cardiomyopathy
Intervention(s)
Drug: Benazepril
Drug: Metoprolol
Drug: Valsartan
Primary Outcome(s)
All cause death or admission for heart failure [Time Frame: 48 months after enrollment]
Secondary Outcome(s)
Changes in NYHA functional class [Time Frame: 6,12, 24 and 36 months after enrollment]
Left-ventricular ejection fraction [Time Frame: 6,12, 24 and 36 months after enrollment]
Left-ventricular end-diastolic diameter [Time Frame: 6, 12 , 24 and 36 months after enrollment]
Secondary ID(s)
SIRAAS-DC
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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