A clinical trial to study the effect of standard treatment of heart failure on plasma levels of Apelin in patients with heart failure.
Not Applicable
Completed
- Conditions
- Health Condition 1: null- Heart Failure,Apelin
- Registration Number
- CTRI/2009/091/000935
- Lead Sponsor
- Department of Pharmacology AIIMSAnsari NagarNew Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
Adult male or female patients aged between 12 and 80 years
Systolic or diastolic heart failure of NYHA class II or more
Mitral stenosis patients posted for Percutaneous Transluminal Mitral Commissurotomy (PTMC)
Healthy age matched controls with normal cardiovascular function
Exclusion Criteria
Diabetes mellitus
Obesity
Hypercholesterolemia
Severe or uncontrolled hypertension
Hepatic or renal failure
Pregnant or lactating women (except for PTMC group)
History of any acute coronary syndrome within previous one month
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in plasma apelin levels with therapy over a follow up period of 12 weeks.Timepoint: Baseline, 1 hour, 14-18 hours and at 12 weeks after PTMC in mitral stenosis patients undergoing the surgery.<br>At baseline and after 12 weeks in other study groups, namely systolic heart failure, diastolic heart failure and healthy control groups.
- Secondary Outcome Measures
Name Time Method -Plasma apelin levels in heart failure patients compared to normal controls at baseline.<br>-Correlation between plasma apelin levels and plasma BNP levels, echocardiographic variables and quality of life parameters over a follow up period of 12 weeks.<br>Timepoint: Baseline and at 12 weeks.