None listed
Conditions
Interventions
Intervention1: Metoprolol CR: 25/50/100 mg od for 12 weeks
Control Intervention1: placebo: 25/50/100 mg od for 12 weeks
Sponsors
samir malhotra
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| proportion of patients showing improvement of &#8805; 1 in NYHA classTimepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| ? proportion of patients exhibiting any alteration in NYHA heart failure class from baseline ? Alteration in exercise capacity using exercise stress testing (treadmill test : Bruce protocol) ? Change in tissue doppler indices of diastolic dysfunction (ratio of mitral inflow velocity to annular relaxation velocity i.e. E/E? ratio) ? Change in left ventricular wall thickness, left ventricular mass and left atrial volume on echocardiography ? Change in serum NT-proBNP levels from baseline ? Change in serum carboxy-terminal propeptide of procollagen type I (PICP) from baseline ? Alteration in quality of life using SF-36 questionnaire ? incidence of adverse eventsTimepoint: 0 and 12 weeks | — |
Countries
India
Contacts
Public ContactSamir Malhotra
Outcome results
None listed