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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03882710
Recruitment Status : Completed
First Posted : March 20, 2019
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
SHotra, Postgraduate Institute of Medical Education and Research

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.

Condition or disease Intervention/treatment Phase
Diastolic Heart Failure Drug: Metoprolol XR Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : January 2010
Actual Primary Completion Date : October 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: metoprolol XR capsule Drug: Metoprolol XR
Metoprolol XR capsule 25/50/100 mg once daily for 12 weeks
Other Name: Metolar XL

Placebo Comparator: placebo capsule Drug: Metoprolol XR
Metoprolol XR capsule 25/50/100 mg once daily for 12 weeks
Other Name: Metolar XL




Primary Outcome Measures :
  1. Proportion of patients showing improvement of ≥ 1 in NYHA class [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. proportion of patients exhibiting any alteration in NYHA heart failure class from baseline [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03882710


Locations
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India
PGIMER
Chandigarh, UT-Chandigarh, India, 160012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
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Principal Investigator: Samir Malhotra, MD, DM Postgraduate Institute of Medical Education and Research
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Responsible Party: SHotra, professor, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT03882710    
Other Study ID Numbers: PGI_Pharma_HFNEF 2010
First Posted: March 20, 2019    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Keywords provided by SHotra, Postgraduate Institute of Medical Education and Research:
heart failure, metoprolol, diastolic dysfunction
Additional relevant MeSH terms:
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Heart Failure
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases
Metoprolol
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action