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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Dong-A University
- 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
Nebivolol 10mg, once a day
Intervention: Nebivolol (Drug)
Carvedilol
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
Kyungil Park
Assistant Professor
Dong-A University