Comparative Effects of Nebivolol and Carvedilol on Diastolic Function in the Elderly Heart Failure Patients
This trial is active, not recruiting.
|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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Nebivolol 10mg, once a day
Carvedilol 25mg, twice a day
the ratio of transmitral E velocity to early diastolic mitral annular velocity (E/E')
time frame: 12 months
Male or female participants at least 70 years old.
Inclusion Criteria: - more than 70 years - EF ≥ 40% Exclusion Criteria: - contraindication to the study drug
|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.|
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