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Clinical Trials/NCT02619526
NCT02619526UnknownNot Applicable

Comparative Effects of Nebivolol and Carvedilol on Diastolic Function of the Left Ventricle in the Elderly Heart Failure Patients With Preserved Ejection Fraction: Study Protocol for a Randomized Controlled Trial

Dong-A University1 site in 1 country62 target enrollmentStarted: December 2016Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Enrollment
62
Locations
1
Primary Endpoint
the ratio of transmitral E velocity to early diastolic mitral annular velocity (E/E')

Study Overview

Brief Summary

Heart failure (HF) is a common and disabling condition in the elderly. Randomized clinical trials and meta-analyses have clearly demonstrated that long-term use of β blockers improves the outcomes of patients with HF. However, limited data have been available on the treatment of HF with preserved ejection fraction (EF) in the elderly. No study has specifically compared the relative effectiveness of carvedilol and nebivolol in treating HF in old age patients with preserved EF.

Detailed Description

This trial is a prospective, randomized, open-label, active controlled study designed to investigate effects of nebivolol and carvedilol on diastolic function of the left ventricle (LV) in the elderly HF patients with preserved EF.

Patients will be included in the study if they had LVEF ≥ 40%, NYHA functional class I, II or III, and clinical stability without hospital admission for HF in the preceding 3 months.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
70 Years to 95 Years (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • more than 70 years

Exclusion Criteria

  • contraindication to the study drug

Arms & Interventions

Nebivolol

Experimental

Nebivolol 10mg, once a day

Intervention: Nebivolol (Drug)

Carvedilol

Active Comparator

Carvedilol 25mg, twice a day

Intervention: Carvedilol (Drug)

Outcomes

Primary Outcomes

the ratio of transmitral E velocity to early diastolic mitral annular velocity (E/E')

Time Frame: 12 months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kyungil Park

Assistant Professor

Dong-A University

Study Sites (1)

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