UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009601 |
|---|---|
| Receipt number | R000011262 |
| Scientific Title | Methyldigoxin versus bisoprolol fumarate against chronic heart failure and permanent atrial fibrillation : a prospective randomized trial |
| Date of disclosure of the study information | 2012/12/24 |
| Last modified on | 2012/12/21 11:17:39 |
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Basic information
Public title
Methyldigoxin versus bisoprolol fumarate against chronic heart failure and permanent atrial fibrillation : a prospective randomized trial
Acronym
NAgoya methyldigoxin vs BIsoprolol study against permanent atrial fibrillation(NABI)
Scientific Title
Methyldigoxin versus bisoprolol fumarate against chronic heart failure and permanent atrial fibrillation : a prospective randomized trial
Scientific Title:Acronym
NAgoya methyldigoxin vs BIsoprolol study against permanent atrial fibrillation(NABI)
Region
| Japan |
Condition
Condition
permanent atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of methyldigoxin and bisoplol fumarate against chronic heart failure and permanent atrial fibrillation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
left atrial dimension and BNP at 12 months
Key secondary outcomes
1. left atrial dimension and BNP at 6 months
2. LVEF and left ventricular mass index at 6 and 12 months
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
methyldigoxin, 12 months
Interventions/Control_2
bisoprolol fumarate, 12 months
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients who have permanent atrial fibrillation
2) Patients who have chronic heart failure
3) Patients who are aged 20 years or older and less than 90 years at the time of obtaining informed consent
4) Patients who have personally and voluntarily provided written informed consent, after having received and thoroughly understood an adequate explanation about participation in the study.
5) Ambulatory patients
6) Patients without rate control against permanent atrial fibrillation , in principle
Key exclusion criteria
1) Patients receiving digitalis preparations or beta blockers
2) Patients with organic heart diseases, such as valvular diseases.
3) Patients with obstructive cardiomyopathy, such as idiopathic hypertrophic subaortic stenosis
4) Patients with severe bradycardia (marked sinus bradycardia),
2nd or 3rd degree atrioventricular block, sinoatrial block, or sick sinus syndrome
5) Patients with bradycardia less than 50 beats/min
6) Patients with digitalis intoxication
7) Patients with diabetic ketoacidosis or metabolic acidosis
8) Patients with cardiogenic shock
9) Patients with right heart failure secondary to pulmonary hypertension
10) Patients with heart failure necessary to administer cardiac stimulants or vasodilators intravenously
11) Patients with decompensated heart failure
12) Patients with severe peripheral artery disease
13) Patients with untreated pheochromocytoma
14) Patients with a history of hypersensitivity to any of the ingredients of the experimental drugs
15) Patients with severe hepatic disease (e.g. AST(GOT) levels or ALT(GPT) levels > 100U IU/L)
16) Patients with severe renal disease (e.g. BUN levels > 25 mg/dL or serum creatinine levels > 2.0mg/dL)
17) Women of confirmed or potential pregnancy
18) Nursing patients
19) Patients who participated in other clinical trials within 3 months of administrating the experimental drugs
20) Patients who are judged unsuitable for this study by the doctor in charge of the patients
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuya Inden |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Cardiology
Zip code
Address
65 Tsurumai, Showa, Nagoya, Aichi466-8550, Japan
TEL
052-744-2150
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuya Inden |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Cardiology
Zip code
Address
65 Tsurumai, Showa, Nagoya, Aichi466-8550, Japan
TEL
052-744-2150
Homepage URL
inden@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Cardiology, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
KARIYA TOYOTA General Hospital
Konan Kosei Hospital
Tsushima City Hospital
TOYOTA Memorial Hospital
Nagoya Central Hospital
Meijo Hospital
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Address
Tel
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
名古屋大学医学部附属病院（愛知県）、刈谷豊田総合病院（愛知県）、江南厚生病院（愛知県）、津島市民病院（愛知県）、トヨタ記念病院（愛知県）、名古屋ｾﾝﾄﾗﾙ病院（愛知県）、名城病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 24 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 21 | Day |
Last modified on
| 2012 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011262
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
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