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Clinical Trials/NCT01104558
NCT01104558CompletedPhase 4

Association Between Beta-1 and Beta-2 Adrenergic Receptor Polymorphism and Beta-blocker (Bisoprolol) Therapy in Heart Failure

Merck KGaA, Darmstadt, Germany2 sites in 2 countries100 target enrollmentStarted: December 2008Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
100
Locations
2
Primary Endpoint
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)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Detailed Description

Heart failure impairs the quality of life of an individual and is considered to be the main cause of morbidity and mortality. Prognosis of HF subjects depends on severity, age and sex. Subjects with HF require lifelong treatment. Pharmacological treatment aims to improve both the quality of life and survival of HF subjects.

OBJECTIVES:

Primary objective:

  • To analyze the association between genetic polymorphism of beta-adrenergic receptor and the effects of beta-blocker (bisoprolol) in Korean HF subjects

Secondary objective:

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •>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%

Exclusion Criteria

  • •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

Outcomes

Primary Outcomes

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)

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: Baseline and Week 26 (or EOT)

Secondary Outcomes

  • Change From Baseline in Heart Rate (6 MWT- Before Walking) 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 Heart Rate (6 MWT- Before Walking) 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 Heart Rate (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT(Baseline and Week 26 (or EOT))
  • Change From Baseline in Heart Rate (6 MWT- After Walking) 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 SBP (6 MWT- After Walking) 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 SBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT(Baseline and Week 26 (or EOT))
  • 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 Heart Rate (6 MWT- Before Walking) 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 Heart Rate (6 MWT- After Walking) 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 Heart Rate (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT(Baseline and 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))
  • Change From Baseline in 6-minute Walking Test (6-MWT) Distance According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT(Baseline and Week 26 (or EOT))
  • Change From Baseline in Heart Rate (6 MWT- After Walking) 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 Diastolic Blood Pressure (DBP) (6 MWT- Before Walking) 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 DBP (6 MWT- Before Walking) 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 DBP (6 MWT- Before Walking) 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 DBP (6 MWT- After Walking) 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 DBP (6 MWT- After Walking) 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 Systolic Blood Pressure (SBP) (6 MWT- Before Walking) 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 SBP (6 MWT- Before Walking) 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 SBP (6 MWT- Before Walking) 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 SBP (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT(Baseline and Week 26 (or EOT))
  • Change From Baseline in SBP (6 MWT- After Walking) 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 SBP (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT(Baseline and Week 26 (or EOT))
  • Change From Baseline in DBP (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT(Baseline and Week 26 (or EOT))
  • Change From Baseline in DBP (6 MWT- After Walking) 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 DBP (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT(Baseline and Week 26 (or EOT))
  • Change From Baseline in Pro-B-type Natriuretic Peptide (BNP) Levels 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 Pro-BNP Levels 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 Pro-BNP Levels 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 Pro-BNP Levels According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT(Baseline and Week 26 (or EOT))

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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