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

Primary Purpose

Diastolic Heart Failure

Status

Completed

Phase

Phase 2

Locations

India

Study Type

Interventional

Intervention

Metoprolol XR

About this trial

This is an interventional treatment trial for Diastolic Heart Failure focused on measuring heart failure, metoprolol, diastolic dysfunction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

PGIMER

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

metoprolol XR capsule

placebo capsule

Arm Description

Outcomes

Primary Outcome Measures

Proportion of patients showing improvement of ≥ 1 in NYHA class

Secondary Outcome Measures

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

Full Information

NCT ID

NCT03882710

First Posted

March 18, 2019

Last Updated

March 19, 2019

Sponsor

Postgraduate Institute of Medical Education and Research

1. Study Identification

Unique Protocol Identification Number

NCT03882710

Brief Title

Metoprolol XR in Heart Failure With Normal Ejection Fraction

Acronym

HFNEF

Official Title

Evaluation of Efficacy and Safety of Metoprolol XR in Patients Having Heart Failure With Normal Ejection Fraction: A Randomised, Double Blind,Placebo Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Postgraduate Institute of Medical Education and Research

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diastolic Heart Failure

Keywords

heart failure, metoprolol, diastolic dysfunction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

102 (Actual)

8. Arms, Groups, and Interventions

Arm Title

metoprolol XR capsule

Arm Type

Experimental

Arm Title

placebo capsule

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Metoprolol XR

Other Intervention Name(s)

Metolar XL

Intervention Description

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

Primary Outcome Measure Information:

Title

Proportion of patients showing improvement of ≥ 1 in NYHA class

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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 ≥ 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Samir Malhotra, MD, DM

Organizational Affiliation

Postgraduate Institute of Medical Education and Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

PGIMER

City

Chandigarh

State/Province

UT-Chandigarh

ZIP/Postal Code

160012

Country

India

12. IPD Sharing Statement

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