Association Between Genetic Polymorphism of Beta-adrenergic Receptor and Effects of Bisoprolol in Korean Heart Failure Patients.

NCT01104558 | Completed Phase 4 Results

• 1 other identifier: EMD084000-500
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

At present, there is some clinical data for different functional response to beta-blockers associated with beta-adrenergic receptor polymorphisms. But there has been no data reported, about the incidence of beta-adrenergic receptor polymorphism and association with beta-adrenergic receptor polymorphism and response to beta-blocker therapy in Korean heart failure (HF) subjects. This single-arm, open-label, multicentric study is designed with the purpose of analyzing the association between genetic polymorphism of beta-adrenergic receptor and the effects of beta-blocker (bisoprolol) in Korean HF subjects.

Conditions

Chronic Heart Failure

Keywords

Bisoprolol; Chronic Heart failure

Outcome Measures

Primary Outcomes (4)

• Change From Baseline in Echocardiographic Left Ventricular Ejection Fraction (LVEF) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or End of Treatment (EOT)

  Baseline and Week 26 (or EOT)

• Change From Baseline in Echocardiographic LVEF According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT

  Baseline and Week 26 (or EOT)

• Change From Baseline in Echocardiographic LVEF According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT

  Baseline and Week 26 (or EOT)

• Change From Baseline in Echocardiographic LVEF According to the Genetic Polymorphism of G Protein-coupled Receptor Kinase 5 (GRK5)-AG at Week 26 or EOT

  Baseline and Week 26 (or EOT)

Secondary Outcomes (34)

• Number of Participants With Hospitalization Due to Heart Failure

  Baseline to Week 26 (or EOT)

• Duration of Hospitalization Due to Heart Failure

  Baseline to Week 26 (or EOT)

• Change From Baseline in 6-minute Walking Test (6-MWT) Distance According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT

  Baseline and Week 26 (or EOT)

• Change From Baseline in 6-MWT Distance According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT

  Baseline and Week 26 (or EOT)

• Change From Baseline in 6-MWT Distance According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT

  Baseline and Week 26 (or EOT)

Interventions

Bisoprolol DRUG

Bisoprolol will be given in a starting dose of 1.25 milligram (mg) once daily for two weeks and if it is well tolerated, the dose will be increased to 2.5 mg, 3.75 mg, 5 mg once daily in intervals of two weeks, 5 mg daily as a maintenance therapy. If the subject is tolerable, the dose can be increased as 10 mg/day as maximum dose.

Also known as: Concor

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 years of age and \<80 years of age
• Chronic heart failure subjects with stable clinical condition
• New York Heart Association (NYHA) functional classification II-III
• Left ventricular ejection fraction (LVEF) ≤45%

You may not qualify if:

• NYHA functional classification IV
• Acute myocardial infarction, Unstable Angina Pectoris, Coronary artery bypass graft, Percutaneous coronary intervention (PCI), Valve surgery in the preceding 3 months
• Hypersensitivity to bisoprolol or any of the Concor excipients
• Subjects with over mild valvular stenosis and severe(Grade III/IV) pulmonary insufficiency
• Systolic Blood Pressure \<90 millimeters of mercury (mmHg) at screening
• Resting Heart Rate \<55 beats per minute (bpm) confirmed by electrocardiogram (ECG) at screening
• Subjects who are taking concomitant drug which can have drug-drug interaction (DDI) with bisoprolol
• Woman of childbearing age without effective contraception measures, or who are pregnant or lactating

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead
• Merck Ltd.: collaborator

Study Sites (1)

The Catholic University of Korea Seoul St. Mary's Hospital, 505, Banpodong, SeoChoGu

Seoul, South Korea

Location

MeSH Terms

Interventions

Bisoprolol

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Results Point of Contact

• Title: Merck KGaA Communication Center
• Organization: Merck Serono, a division of Merck KGaA

service@merckgroup.com

+49-6151-72-5200

Study Officials

• Medical Responsible

  Merck Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2010
• First Posted: April 15, 2010
• Study Start: December 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: February 13, 2014
• Results First Posted: April 10, 2012

Record last verified: 2014-01

Locations

KR (1)