| Study name |
Evaluation of efficacy and safety of metoprolol in patients having heart failure with normal ejection fraction: a randomised, double‐blind, placebo‐controlled trial |
| Methods |
Study design: parallel RCT
Anticipated completion date: November 2011 |
| Participants |
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 ≥ 50% in a nondilated LV (LV end‐diastolic volume <97ml/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 ≥ 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
|
| Interventions |
Metoprolol CR versus placebo
12 weeks |
| Outcomes |
proportion of patients showing improvement of ≥ 1 in NYHA class; 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 events |
| Starting date |
15 November 2009 |
| Contact information |
Samir Malhotra: samirmalhotra345@yahoo.com |
| Notes |
|
