UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004949 |
|---|---|
| Receipt number | R000005814 |
| Scientific Title | Heart rate control for patients with atrial fibrillation and hypertension:Efficacy and safety of carvedilol |
| Date of disclosure of the study information | 2011/02/01 |
| Last modified on | 2011/01/25 18:42:44 |
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Basic information
Public title
Heart rate control for patients with atrial fibrillation and hypertension:Efficacy and safety of carvedilol
Acronym
Heart rate control for patients with atrial fibrillation and hypertension:Efficacy and safety of carvedilol
Scientific Title
Heart rate control for patients with atrial fibrillation and hypertension:Efficacy and safety of carvedilol
Scientific Title:Acronym
Heart rate control for patients with atrial fibrillation and hypertension:Efficacy and safety of carvedilol
Region
| Japan |
Condition
Condition
atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of carvedilol for patients with atrial fibrillation and hypertension.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
improvement of QOL
Key secondary outcomes
rate control
cardiovascular event
cardiac function
inflammatory markers
oxidative stress markers
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
permanent atrial fibrillation
hypertension
either out or in hospital follow up
Key exclusion criteria
heart failure,severe cardiac dysfunction
high degree atrio-ventricular block,sick sinus syndrome,bradycardia
bronchial asthma
diabetic ketoacidosis,metabolic acidosis
acute myocardial infarction
dialysis patient,severe renal dysfunction
pregnant woman,woman with chance of pregnancy
untreated pheochromocytoma
hypersensitivity to the medicine
a case determined inappropriate
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Kurita |
Organization
Kinki University School of Medicine
Division name
Division of Cardiology,Department of Internal Medicine
Zip code
Address
377-2,Ohno-Higashi,Osaka-Sayama,Osaka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kinki University School of Medicine
Division name
Division of Cardiology,Department of Internal Medicine
Zip code
Address
TEL
Homepage URL
http://www.med.kindai.ac.jp/rinri/
Sponsor or person
Institute
Division of Cardiology,Department of Internal Medicine,Kinki University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Cardiology,Department of Internal Medicine,Kinki University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2010 | Year | 11 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
to evaluate the efficacy and safety of carvedilol
Management information
Registered date
| 2011 | Year | 01 | Month | 25 | Day |
Last modified on
| 2011 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005814
