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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000000561
Receipt No. R000000681
Scientific Title Supplemental Benefit of Angiotensin II Receptor Blocker in Hypertensive Patients with Stable Heart Failure using Olmesartan
Date of disclosure of the study information 2006/12/26
Last modified on 2011/12/26

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Basic information
Public title Supplemental Benefit of Angiotensin II Receptor Blocker in Hypertensive Patients with Stable Heart Failure using Olmesartan
Acronym SUPPORT Trial
Scientific Title Supplemental Benefit of Angiotensin II Receptor Blocker in Hypertensive Patients with Stable Heart Failure using Olmesartan
Scientific Title:Acronym SUPPORT Trial
Region
Japan

Condition
Condition Chronic Heart Failure
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of olmesartan in reducing the mortality and morbidity for hypertensive patients with chronic heart failure.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes A composite of all-cause death, nonfatal acute myocardial infarction, nonfatal stroke, and hospital admission due to congestive heart failure.
Key secondary outcomes Secondary outcomes
1)all-cause death
2)cardiovascular death
3)death due to heart failure
4)sudden death
5)acute myocardial infarction
6)stroke
7)hospital admission from any cardiovascular reasons

Other outcomes
1)fatal arrhythmia or appropriate ICD discharge
2)new-onset diabetes
3)development of renal failure
4)new-onset atrial fibrillation
5)a need to modify treatment procedures for heart failure
6)left ventricular ejection fraction
7)BNP

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 considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Olmesartan 5-40mg 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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Patients who meet all of the following criteria.
1)Chronic heart failure patients with NYHA function class II, III, or IV.
2)Patients who have a history of hypertension or those who have antihypertensive medications.
3)Patients who are aged 20 years or older and less than 80 years at the entry.
4)Stable patients who have angiotensin converting enzyme inhibitor and/or beta-blocker.
5)Patients who do not have angiotensin II receptor blocker.
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 olmesartan.
3)Patients who have severe liver dysfunction.
4)History of angioedema.
5)History of malignant tumor or life-threatening illness of poor prognosis.
6)Pregnant or possibly pregnant patients.
7)Cardiovascular surgery within 6months prior to the date of the entry.
8)Acute myocardial infarction within 6 months prior to the date of the entry.
9)Percutaneous coronary intervention or stent implantation within 6 months prior to the date of the entry.
10)Other patients deemed unsuitable as subjects of the study by the treating physician.
Target sample size 1000

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, Seiryo-machi, Aoba-ku, Sendai-city
TEL 022-717-7153
Email

Public contact
Name of contact person
1st name
Middle name
Last name Nobuyuki Shiba
Organization Tohoku University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1, Seiryo-machi, Aoba-ku, Sendai-city
TEL 022-717-7153
Homepage URL http://tohoku.cardiovascular-medicine.jp
Email nshiba@cardio.med.tohoku.ac.jp

Sponsor
Institute Tohoku Heart Failure Association
The SUPPORT Study Group
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
2006 Year 12 Month 26 Day

Related information
URL releasing protocol http://tohoku.cardiovascular-medicine.jp
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 No longer recruiting
Date of protocol fixation
2006 Year 09 Month 04 Day
Date of IRB
Anticipated trial start date
2006 Year 11 Month 01 Day
Last follow-up date
2013 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
2006 Year 12 Month 26 Day
Last modified on
2011 Year 12 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000681

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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