A clinical trial to study the efficacy and safety of metoprolol in heart failure with normal ejection fractio
- Registration Number
- CTRI/2010/091/000438
- Lead Sponsor
- samir malhotra
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 102
?Age 18 years and above of either sex
?Presence of New York Heart Association functional class II?IV of at least 4 weeks? duration
?LVEF ≥ 50% in a nondilated LV (LV end-diastolic volume < 97 ml/m2 measured by echocardiography)
?Echocardiographic evidence of LV diastolic dysfunction
?Willing to give written informed consent
?Clinically unstable as defined by any change in diuretic dose in the month prior to enrolment.
?Significant valvular heart disease, pericardial disease, hypertrophic or restrictive cardiomyopathy
?Unstable angina or MI within the past 4 weeks.
?Alternative probable cause of the patient?s symptoms (e.g.significant pulmonary disease);
?Any previous left ventricular ejection fraction below 40%
?Other systemic disease limiting life expectancy to less than 3 years
?Any contraindication to metoprolol use (heart rate less than 45 beats per minute, heart block greater than first-degree i.e. PR interval ≥ 0.24 second, systolic blood pressure <100 mm Hg, asthma)
?Conditions associated with alteration in serum levels of procollagen type I e.g. alcoholic liver disease, metabolic bone disease, hyperthyroidism
?Current participation (including prior 30 days) in any other therapeutic trial
?Any condition that, in the opinion of the investigator, may prevent the participant from adhering to the trial protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method