Metoprolol XR in Heart Failure With Normal Ejection Fraction

NCT03882710 | Completed Phase 2

• 1 other identifier: PGI_Pharma_HFNEF 2010
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diastolic Heart Failure

Keywords

heart failure, metoprolol, diastolic dysfunction

Outcome Measures

Primary Outcomes (1)

• Proportion of patients showing improvement of ≥ 1 in NYHA class

  12 weeks

Secondary Outcomes (1)

• proportion of patients exhibiting any alteration in NYHA heart failure class from baseline

  12 weeks

Study Arms (2)

metoprolol XR capsule

EXPERIMENTAL

Drug: Metoprolol XR

placebo capsule

PLACEBO COMPARATOR

Drug: Metoprolol XR

Interventions

Metoprolol XR DRUG

Metoprolol XR capsule 25/50/100 mg once daily for 12 weeks

Also known as: Metolar XL

metoprolol XR capsule; placebo capsule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

PGIMER

Chandigarh, UT-Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Heart Failure, Diastolic; Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Samir Malhotra, MD, DM

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: March 20, 2019
• Study Start: January 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 21, 2019

Record last verified: 2019-03

Locations

IN (1)