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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000009601
Receipt No. 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

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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
Email

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
Email inden@med.nagoya-u.ac.jp

Sponsor
Institute Department of Cardiology, Nagoya University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011262

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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