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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| metoprolol XR capsule | Experimental |
| |
| placebo capsule | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metoprolol XR | Drug | Metoprolol XR capsule 25/50/100 mg once daily for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients showing improvement of ≥ 1 in NYHA class | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| proportion of patients exhibiting any alteration in NYHA heart failure class from baseline | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samir Malhotra, MD, DM | Post Graduate Institute of Medical Education and Research, Chandigarh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PGIMER | Chandigarh | UT-Chandigarh | 160012 | India |
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| ID | Term |
|---|---|
| D054144 | Heart Failure, Diastolic |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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