Comparative Effects of Nebivolol and Carvedilol on Diasto... | NCT02619526

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

NCT02619526

Sponsor

Dong-A University

Status

Unknown status

Last Update Posted

Feb 5, 2018Actual

Enrollment

62Estimated

Phase

Not Applicable

Conditions

Heart Failure

Interventions

Nebivolol
Carvedilol

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2016Actual

Primary Completion Date

Jul 2018Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Nov 25, 2015

First Submission Date that Met QC Criteria

Nov 30, 2015

First Posted Date

Dec 2, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 2, 2018

Last Update Posted Date

Feb 5, 2018Actual

Name	Class
Menarini Group	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

62Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nebivolol	Experimental	Nebivolol 10mg, once a day	Drug: Nebivolol
Carvedilol	Active Comparator	Carvedilol 25mg, twice a day	Drug: Carvedilol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nebivolol	Drug	Nebivolol 10mg, once a day	Nebivolol
Carvedilol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the ratio of transmitral E velocity to early diastolic mitral annular velocity (E/E')		12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

more than 70 years
EF ≥ 40%

Exclusion Criteria:

contraindication to the study drug

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

70 Years

Maximum Age

95 Years

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yieun-Ji Lee, RN	Contact	82-51-240-2959		oneday140412@naver.com

Overall Officials

Name	Affiliation	Role
Tae-Ho Park, MD	Dong-A University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Internal Medicine,Dong-A University College of Medicine	Recruiting	Busan			South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27809882	Derived	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.

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

ID	Term
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals