Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-26 @ 4:52 PM
Study NCT ID:
NCT01104558
Status:
COMPLETED
Last Update Posted:
2014-02-13
First Post:
2010-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Association Between Genetic Polymorphism of Beta-adrenergic Receptor and Effects of Bisoprolol in Korean Heart Failure Patients.
Sponsor:
Merck KGaA, Darmstadt, Germany
Organization:
Study Overview
Official Title:
Association Between Beta-1 and Beta-2 Adrenergic Receptor Polymorphism and Beta-blocker (Bisoprolol) Therapy in Heart Failure
Status:
COMPLETED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ABBA
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:
* The frequency of polymorphism of beta adrenergic receptor in Korean HF subjects
* To evaluate change from baseline in 6-minute walking test, heart rate (HR), blood pressure (BP), pro B-type natriuretic peptide (BNP) level at week 26 or End of Treatment (EOT)
* To compare frequency and duration of hospitalization due to heart failure
The method involved in this study will be as follows:
* Initial evaluation of HF subjects
* Blood genomic deoxyribonucleic acid (DNA) isolation and collection
* Bisoprolol treatment as add on therapy with standard treatment for HF subject for 6 months
* Genotype of beta adrenergic receptor polymorphism
* Follow up evaluation of treated subjects
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.
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:
* The frequency of polymorphism of beta adrenergic receptor in Korean HF subjects
* To evaluate change from baseline in 6-minute walking test, heart rate (HR), blood pressure (BP), pro B-type natriuretic peptide (BNP) level at week 26 or End of Treatment (EOT)
* To compare frequency and duration of hospitalization due to heart failure
The method involved in this study will be as follows:
* Initial evaluation of HF subjects
* Blood genomic deoxyribonucleic acid (DNA) isolation and collection
* Bisoprolol treatment as add on therapy with standard treatment for HF subject for 6 months
* Genotype of beta adrenergic receptor polymorphism
* Follow up evaluation of treated subjects
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: