UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000561 |
|---|---|
| Receipt number | 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 11:28:12 |
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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
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
nshiba@cardio.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku Heart Failure Association
The SUPPORT Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000681
