Comparative Effects of Nebivolol and Carvedilol on Diastolic Function in the Elderly Heart Failure Patients
1 other identifier
interventional
62
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable heart-failure
Started Dec 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2015
CompletedFirst Posted
Study publicly available on registry
December 2, 2015
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedFebruary 5, 2018
February 1, 2018
1.6 years
November 25, 2015
February 2, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
the ratio of transmitral E velocity to early diastolic mitral annular velocity (E/E')
12 months
Study Arms (2)
Nebivolol
EXPERIMENTALNebivolol 10mg, once a day
Carvedilol
ACTIVE COMPARATORCarvedilol 25mg, twice a day
Interventions
Eligibility Criteria
You may qualify if:
- more than 70 years
- EF ≥ 40%
You may not qualify if:
- contraindication to the study drug
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dong-A Universitylead
- Menarini Groupcollaborator
Study Sites (1)
Department of Internal Medicine,Dong-A University College of Medicine
Busan, South Korea
Related Publications (1)
Park K, Park TH. Comparative effects of nebivolol and carvedilol on left ventricular diastolic function in older heart failure patients with preserved ejection fraction: study protocol for a randomized controlled trial. Trials. 2016 Nov 3;17(1):530. doi: 10.1186/s13063-016-1656-y.
PMID: 27809882DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tae-Ho Park, MD
Dong-A University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
November 25, 2015
First Posted
December 2, 2015
Study Start
December 1, 2016
Primary Completion
July 1, 2018
Study Completion
December 1, 2018
Last Updated
February 5, 2018
Record last verified: 2018-02