Comparative Effects of Nebivolol and Carvedilol on Diastolic Function in the Elderly Heart Failure Patients

Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02619526
• Other study ID #: 15-174
• Status: Recruiting
• Phase: N/A
• First received: November 25, 2015
• Last updated: February 2, 2018
• Start date: December 2016
• Est. completion date: December 2018

Study information

• Verified date: February 2018
• Source: Dong-A University
• Contact: Yieun-Ji Lee, RN
• Phone: 82-51-240-2959
• Email: oneday140412[@]naver.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: December 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years to 95 Years

Eligibility

Inclusion Criteria:

• more than 70 years

• EF = 40%

Exclusion Criteria:

• contraindication to the study drug

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• Nebivolol
Nebivolol 10mg, once a day
• Carvedilol
Carvedilol 25mg, twice a day

Locations

Country	Name	City	State
Korea, Republic of	Department of Internal Medicine,Dong-A University College of Medicine	Busan

Sponsors (2)

Lead Sponsor	Collaborator
Dong-A University	Menarini Group

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the ratio of transmitral E velocity to early diastolic mitral annular velocity (E/E')		12 months