Diastolic Heart FailurePhase 2HFNEFNCT03882710
Metoprolol XR in Heart Failure With Normal Ejection Fraction
A Phase 2 study testing Metoprolol XR in people with Diastolic Heart Failure, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diastolic Heart Failure
- What is being tested?
- Metoprolol XR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2010to Dec 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Metoprolol XR
- Keywords
- heart failure, metoprolol, diastolic dysfunction
- Medical subject headings
- Heart Failure, Diastolic, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metoprolol XRDrug
Also called Metolar XL
Metoprolol XR capsule 25/50/100 mg once daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| metoprolol XR capsule | Experimental | Not described Receives: Drug: Metoprolol XR |
| placebo capsule | Placebo comparator | Not described Receives: Drug: Metoprolol XR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients showing improvement of ≥ 1 in NYHA class
Measured: 12 weeks
Secondary outcomes (1)
proportion of patients exhibiting any alteration in NYHA heart failure class from baseline
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study startJan 2010
- Primary completionOct 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diastolic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SHotra, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Samir Malhotra, MD, DM, Principal investigator, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03882710
- Sponsor's protocol ID
- PGI_Pharma_HFNEF 2010
- Acronym
- HFNEF
- Status last verified
- Mar 2019
- First submitted
- 18 Mar 2019
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03882710
- Acronym / sponsor ID
- HFNEF / PGI_Pharma_HFNEF 2010
- Conditions
- Diastolic Heart Failure
- Keywords
- heart failure, metoprolol, diastolic dysfunction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 20 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| metoprolol XR capsule | Experimental | Drug: Metoprolol XR |
| placebo capsule | Placebo comparator | Drug: Metoprolol XR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metoprolol XRAlso: Metolar XLMetoprolol XR capsule 25/50/100 mg once daily for 12 weeks | Drug | metoprolol XR capsule, placebo capsule |
Primary outcome
Proportion of patients showing improvement of ≥ 1 in NYHA class
Time frame: 12 weeks
1 secondary outcome
proportion of patients exhibiting any alteration in NYHA heart failure class from baseline
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samir Malhotra, MD, DM principal investigator
Post Graduate Institute of Medical Education and Research, Chandigarh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metoprolol XR in people with Diastolic Heart Failure, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients showing improvement of ≥ 1 in NYHA class (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2019.