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A clinical trial to study the efficacy and safety of metoprolol in heart failure with normal ejection fractio

Phase 2
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
Inclusion Criteria

?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 &#8805; 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

Exclusion Criteria

?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 &#8805; 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
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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