Metoprolol XR in Heart Failure With Normal Ejection Fraction (HFNEF)

Post Graduate Institute of Medical Education and Research, Chandigarh

Status and phase

Completed

Phase 2

Conditions

Diastolic Heart Failure

Treatments

Drug: Metoprolol XR

Study type

Interventional

Funder types

Other

Identifiers

NCT03882710

PGI_Pharma_HFNEF 2010

Details and patient eligibility

About

In contrast to the treatment of HF with reduced EF, information to guide the pharmacological therapy of patients with HFNEF are lacking and there is no evidence based treatment for patients with HFNEF. Thus, present treatment strategies for HFNEF are largely based on assumptions regarding its pathophysiological mechanisms and on extrapolations from proven strategies used in systolic HF. Till now, no study enlightens the efficacy and safety of beta blockers in HFNEF in a randomised controlled manner although the role of beta blockers in HF with impaired systolic function has been sufficiently time tested leading to their therapeutic approval in that condition. Keeping in view the small reported benefit of beta blockers in HFNEF as mentioned above, there is a need to provide a conclusive proof of their role in this condition as well. Hence, investigators planned to test the efficacy and safety of metoprolol CR in patients with HFNEF in a randomised double blind placebo controlled trial.

Enrollment

102 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 < 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 ≥ 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