This trial is active, not recruiting.

Condition heart failure
Treatments nebivolol, carvedilol
Sponsor Dong-A University
Collaborator Menarini Group
Start date November 2015
End date November 2016
Trial size 62 participants
Trial identifier NCT02619526, 15-174


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Nebivolol 10mg, once a day
Nebivolol 10mg, once a day
(Active Comparator)
Carvedilol 25mg, twice a day
Carvedilol 25mg, twice a day

Primary Outcomes

the ratio of transmitral E velocity to early diastolic mitral annular velocity (E/E')
time frame: 12 months

Eligibility Criteria

Male or female participants at least 70 years old.

Inclusion Criteria: - more than 70 years - EF ≥ 40% Exclusion Criteria: - contraindication to the study drug

Additional Information

Official title 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
Principal investigator Tae-Ho Park, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Dong-A University.