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

• Sponsor: Dong-A University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02619526
• Collaborator: Menarini Group (Industry)
• Enrollment: 62
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 2.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Drug: Nebivolol; Drug: Carvedilol	N/A

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
• Anticipated Enrollment: 62 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Dec 1, 2016
• Anticipated Primary Completion Date: Jul 1, 2018
• Anticipated Study Completion Date: Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nebivolol Nebivolol 10mg, once a day	Drug: Nebivolol; Nebivolol 10mg, once a day
Active Comparator: Carvedilol Carvedilol 25mg, twice a day	Drug: Carvedilol; Carvedilol 25mg, twice a day

Outcome Measures

Primary Outcome Measures

1. the ratio of transmitral E velocity to early diastolic mitral annular velocity (E/E') [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 70 Years to 95 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• more than 70 years

• EF ≥ 40%

Exclusion Criteria:

• contraindication to the study drug

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Internal Medicine,Dong-A University College of Medicine	Busan		Korea, Republic of

Sponsors and Collaborators

• Dong-A University
• Menarini Group

Investigators

• Principal Investigator: Tae-Ho Park, MD, Dong-A University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kyungil Park, Assistant Professor, Dong-A University
• ClinicalTrials.gov Identifier: NCT02619526
• Other Study ID Numbers: 15-174
• First Posted: Dec 2, 2015
• Last Update Posted: Feb 5, 2018
• Last Verified: Feb 1, 2018

• Additional relevant MeSH terms: Heart Failure; Carvedilol; Nebivolol

Study Results

No Results Posted as of Feb 5, 2018