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

Primary Purpose

Heart Failure

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Nebivolol

Carvedilol

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

70 Years - 95 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

more than 70 years
EF ≥ 40%

Exclusion Criteria:

contraindication to the study drug

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nebivolol

Carvedilol

Arm Description

Nebivolol 10mg, once a day

Carvedilol 25mg, twice a day

Outcomes

Primary Outcome Measures

the ratio of transmitral E velocity to early diastolic mitral annular velocity (E/E')

Secondary Outcome Measures

Full Information

NCT ID

NCT02619526

First Posted

November 25, 2015

Last Updated

February 2, 2018

Sponsor

Dong-A University

Collaborators

Menarini Group

1. Study Identification

Unique Protocol Identification Number

NCT02619526

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Unknown status

Study Start Date

December 2016 (Actual)

Primary Completion Date

July 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dong-A University

Collaborators

Menarini Group

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Nebivolol

Arm Type

Experimental

Arm Description

Nebivolol 10mg, once a day

Arm Title

Carvedilol

Arm Type

Active Comparator

Arm Description

Carvedilol 25mg, twice a day

Intervention Type

Drug

Intervention Name(s)

Nebivolol

Intervention Description

Nebivolol 10mg, once a day

Intervention Type

Drug

Intervention Name(s)

Carvedilol

Intervention Description

Carvedilol 25mg, twice a day

Primary Outcome Measure Information:

Title

the ratio of transmitral E velocity to early diastolic mitral annular velocity (E/E')

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

70 Years

Maximum Age & Unit of Time

95 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: more than 70 years EF ≥ 40% Exclusion Criteria: contraindication to the study drug

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yieun-Ji Lee, RN

Phone

82-51-240-2959

oneday140412@naver.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tae-Ho Park, MD

Organizational Affiliation

Dong-A University

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Busan

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kyungil Park, MD

Phone

82-51-240-2733

sotier@dau.ac.kr

12. IPD Sharing Statement

Citations:

PubMed Identifier

27809882

Citation

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.

Results Reference

derived

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

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