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

NCT ID: NCT02619526

Last Updated: 2018-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nebivolol

Nebivolol 10mg, once a day

Group Type EXPERIMENTAL

Nebivolol

Intervention Type DRUG

Nebivolol 10mg, once a day

Carvedilol

Carvedilol 25mg, twice a day

Group Type ACTIVE_COMPARATOR

Carvedilol

Intervention Type DRUG

Carvedilol 25mg, twice a day

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nebivolol

Nebivolol 10mg, once a day

Intervention Type DRUG

Carvedilol

Carvedilol 25mg, twice a day

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* more than 70 years
* EF ≥ 40%

Exclusion Criteria

* contraindication to the study drug
Minimum Eligible Age

70 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Menarini Group

INDUSTRY

Sponsor Role collaborator

Dong-A University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kyungil Park

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tae-Ho Park, MD

Role: PRINCIPAL_INVESTIGATOR

Dong-A University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Internal Medicine,Dong-A University College of Medicine

Busan, , South Korea

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yieun-Ji Lee, RN

Role: CONTACT

82-51-240-2959

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Kyungil Park, MD

Role: primary

82-51-240-2733

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 27809882 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

15-174

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.