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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000000664
Receipt No. R000000800
Scientific Title Supplemental Benefit of ARB in Maintenance of Sinus Rhythm after Left Atrial Ablation in Atrial Fibrillation using Valsartan
Date of disclosure of the study information 2007/04/02
Last modified on 2007/03/31

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Basic information
Public title Supplemental Benefit of ARB in Maintenance of Sinus Rhythm after Left Atrial Ablation in Atrial Fibrillation using Valsartan
Acronym SURV Trial
Scientific Title Supplemental Benefit of ARB in Maintenance of Sinus Rhythm after Left Atrial Ablation in Atrial Fibrillation using Valsartan
Scientific Title:Acronym SURV Trial
Region
Japan

Condition
Condition Atrial Fibrillation
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of Valsartan in maintenance of sinus rhythm after left atrial ablation for hypertensive patients with atrial fibrillation
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes A composite of all - reverse remodeling of left atrium and recurrence of atrial fibrillation.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Valsartan40-80mg daily, during the study period.
Interventions/Control_2 Control
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
30 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria Patients who meet all of the following criteria
(1) symptomatic AF patients with at least two kinds of drug-resistance
(2)Patients who are aged 30 years or older and less than 70 years at the entry
(3) Patients without ischemic cardiovascular disease, valvular disease and cardiomyopathy.
Key exclusion criteria (1)Patients who have renal dysfunction (serum creatinine>=3.0mg/dL or those who are receiving chronic hemodialysis
(2) History of drug hypersensitivity to angiotensine II receptor blocker.
(3)Patients who have severe liver dysfunction
(4)Patents with cerebrovasucular disease
(5)History of angioedema
(6)History of malignant tumor or life threatening illness of poor prognosis
(7)Pregnant or possibly pregnant patients
(8)Patents after Cardiovascular surgery
(9)Other patients deemed unsuitable as subjects of the study by the treating physician
Target sample size 180

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Shimokawa
Organization Tohoku University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1 Seiryou-machi, Sendai-city
TEL 022(717)7153
Email

Public contact
Name of contact person
1st name
Middle name
Last name Koji Kumagai
Organization Tohoku University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1 Seiryou-machi, Sendai-city
TEL
Homepage URL
Email

Sponsor
Institute Department of Cardiovascular Medicine Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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

Other administrative information
Date of disclosure of the study information
2007 Year 04 Month 02 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
2006 Year 11 Month 20 Day
Date of IRB
Anticipated trial start date
2007 Year 04 Month 01 Day
Last follow-up date
2010 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2007 Year 03 Month 31 Day
Last modified on
2007 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000800

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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