UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023353 |
|---|---|
| Receipt number | R000026166 |
| Scientific Title | An analysis on distribution of serum concentration of bisoprolol and its effect on prognosis in patients with heart failure |
| Date of disclosure of the study information | 2016/07/27 |
| Last modified on | 2021/04/22 18:31:11 |
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Basic information
Public title
An analysis on distribution of serum concentration of bisoprolol and its effect on prognosis in patients with heart failure
Acronym
CVI ARO 6 study
Scientific Title
An analysis on distribution of serum concentration of bisoprolol and its effect on prognosis in patients with heart failure
Scientific Title:Acronym
CVI ARO 6 study
Region
| Japan |
Condition
Condition
Patients with heart failure who are taking bisoprolol
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the distribution of trough serum concentration of bisoprolol and its relationship with prognosis.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Admission or death by heart failure within 1 year after registration
Key secondary outcomes
Primary outcomes and increase of diuretics due to exacerbation of heart failure (loop diuretics, potassium sparing diuretics, thiazide diuretics, selective vasopressin V2-receptor antagonists)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are visiting to the Cardiovascular Institute and taking bisoprolol with diagnosis of heart failure. Patients who meets all of the criteria below.
(1) Age: 20 years and older
(2) In ultrasound cardiogram within 1 year before registration (if multiple data exists, the latest one), systolic dysfunction (left ventricular ejection fraction [LVEF] <50%), or diastolic dysfunction (LVEF >=50% and E/E' >=15) are observed.
(3) Bisoprolol is constantly taken for more than 1 month at blood sampling of serum concentration.
(4) Bisoprolol is administered once a day.
(5) Outpatients
Key exclusion criteria
(1) Inpatients at blood sampling of serum concentration
(2) Dose of bisoprolol was changed within 1 month before blood sampling of serum concentration.
(3) Bisoprolol was administered twice a day within 1 week before blood sampling of serum concentration.
(4) Hyperthyroidism is diagnosed or suspected.
(5) Patients who meet contraindications below:
1) Patients with advanced bradycardia (significant sinus bradycardia), atrioventricular block (II or III degree) , atrioventricular block, and/or sick sinus syndrome
2) Patients with diabetic ketoacidosis, and/or metabolic acidosis
3) Patients with cardiogenic shock
4) Patients with right-sided heart failure by pulmonary hypertension
5) Patients with heart failure requiring intravenous administration of inotropic agents and/or vasodilatory agents
6) Patients with decompensated heart failure
7) Patients with severe peripheral circulatory disturbance
8) Patients with untreated pheochromocytoma
9) Women who are pregnant or may be pregnant
10) Patients who have a history of
hypersensitivity for bisoprolol
(6) Patients who are judged by the researchers as inadequate for this study
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Shinya |
| Middle name | |
| Last name | Suzuki |
Organization
The Cardiovascular Institute
Division name
Department of cardiovascular medicine
Zip code
106-0031
Address
3-2-19 Nishiazabu, Minato-Ku, Tokyo. ZIP: 106-0031
TEL
+81-3-3408-2151
sinsuz-tky@umin.net
Public contact
Name of contact person
| 1st name | Kazumi |
| Middle name | |
| Last name | Matsuda |
Organization
Cardiovascular Institute Academic Research Organization (CVI ARO)
Division name
Head office
Zip code
106-0031
Address
3-2-19 Nishiazabu, Minato-Ku, Tokyo
TEL
+81-3-3408-2151
Homepage URL
matsuda@cvi.or.jp
Sponsor or person
Institute
The Cardiovascular Institute
Institute
Department
Personal name
Funding Source
Organization
Mitsubishi Tanabe Pharma
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of The Cardiovascular Institute
Address
Nishi-azabu 3-2-19, Minato-ku, Tokyo
Tel
03-3408-2151
matsuda@cvi.or.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
心臓血管研究所付属病院（The Cardiovascular Institute）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 27 | Day |
Related information
URL releasing protocol
https://www.cvi.or.jp/kenkyujo/cviaro.html#link01
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/abs/pii/S1347436720300033?via%3Dihub
Number of participants that the trial has enrolled
128
Results
The data of 114 HF patients under once-daily bisoprolol was analyzed.
In multivariate logistic regression analysis, independent predictors of high Bis-PC (1st tertile: >= 5.38 ng/mL) were age, eGFR, and bisoprolol dose.
The cumulative incidence rates of the primary endpoint were 10.5%/13.2%/26.3% in low/middle/high Bis-PC categories, respectively (log rank test, p = 0.087).
Bis-PC was independently associated with the primary endpoint (hazard ratio [HR], 1.19 [per ng/mL], 95% CI 1.03-1.36).
Results date posted
| 2021 | Year | 04 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 01 | Month | 13 | Day |
Baseline Characteristics
Heart failure patients prescribed bisoprolol once per day.
Participant flow
Consecutive eligible patients who visited the Cardiovascular Institute were enrolled.
Adverse events
Admission or death by heart failure: 12
Outcome measures
The cumulative incidences of the primary endpoint at 1-year were 10.5%, 13.2%, and 26.3% in patients in the low, middle, and
high Bis-PC categories.
Plan to share IPD
Available by the first author for reasonable cases
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 09 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The main results were published.
Management information
Registered date
| 2016 | Year | 07 | Month | 27 | Day |
Last modified on
| 2021 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026166
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