UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005511 |
|---|---|
| Receipt number | R000006533 |
| Scientific Title | A Single Center, Open-label, Randomized Comparative Study to Evaluate the Effect of Aliskiren on Myocardial Perfusion Reserve and Coronary Flow Reserve in Hypertensive Patients with a history of Myocardial Infarction |
| Date of disclosure of the study information | 2011/05/01 |
| Last modified on | 2013/05/30 16:53:34 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Single Center, Open-label, Randomized Comparative Study to Evaluate the Effect of Aliskiren on Myocardial Perfusion Reserve and Coronary Flow Reserve in Hypertensive Patients with a history of Myocardial Infarction
Acronym
An Exploratory Study to Evaluate the
Improvement of Myocardial Perfusion Reserve and Coronary Flow Reserve by Aliskiren Treatment in Patients with Prior Myocardial Infarction
Scientific Title
A Single Center, Open-label, Randomized Comparative Study to Evaluate the Effect of Aliskiren on Myocardial Perfusion Reserve and Coronary Flow Reserve in Hypertensive Patients with a history of Myocardial Infarction
Scientific Title:Acronym
An Exploratory Study to Evaluate the
Improvement of Myocardial Perfusion Reserve and Coronary Flow Reserve by Aliskiren Treatment in Patients with Prior Myocardial Infarction
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to assess the effect of aliskiren on myocardial perfusion reserve and coronary flow reserve in hypertensive patients with a history of myocardial infarction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Myocardial Perfusion Reserve (MPR) and Ccoronary Flow Reserve (CFR) by magnetic resonance imaging (MRI) after 24 weeks
Key secondary outcomes
1.Left ventricule mass, End-diastolic and end-systolic left ventricular volume (EDV and ESV) after 24 weeks
2.Change from baseline in systolic and diastolic blood pressure after 12 and 24 weeks
3.Biomarkers including BNP, hs-CRP, PRA and plasma aldosterone after 12 and 24 weeks
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
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
Aliskiren added on the basal treatment
Interventions/Control_2
Non-RAS antihyperetensive drugs added on the basal traetment
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
History of MI more than 6 months prior to the registration, which was treated with standard of care and he/she has been clinically stable, including naïve or standard-dose antihypertensives of RAS blockade (ACE inhibitor or ARB), CCB, diuretics, and/or beta-blocker
Diagnosed with hypertension, ( home BP >125/75 mmHg or clinic BP >130/80mmHg)
Not treated with Aliskiren during 1 month prior to the registration
Treated with standard dose of RAS blockade, that were not modified during 1 month prior to the registration and not scheduled to be modified during the study
Age=20 or >20, and <80 years old
Able to provide written informed consent
Key exclusion criteria
1.Intolerance, anaphylaxis, or any history of hypersensitivity to aliskiren
2.Treated with high dose of RAS blockade
3.Initiation or change-a-dose/discontinuation of statin during 3 months prior to the registration, or planned change in a dose of statin during participating to this study
4.History of coronary artery bypass graft surgery
5.With any contraindication for MRI
a)Pacemaker or ICD
b)Implanted inner ear device
c)Artificial tooth (regarded as an aberration if provided, however, that physician decided it doesn't matter)
d)patient undergoing bronchial asthma treatment
e)History of artificial vessel replacement for aortic aneurysm
f)History of surgical clip therapy for brain aneurysm
g)eGFR<50mL/min/1.73 m2 during 1 month prior to the MRI examination
h)Judged as "Imcompetent for the study" by investigators
i)Intolerance, anaphylaxis, or any history of hypersensitivity to Gd-DTPA
6.Uncontrolled severe diabetes ( HbA1c>9)
7.Unstable angina or a history of acute MI or stroke during 3 months prior to the registration
8.LVEF <30%
9.Severe liver dysfunction
10.Severe kidney disease
11.Pregnant, Women of Child Bearing Potential or using effective methods of contraception as defined by local Health Authority
12.Nursing (lactating) women
13.Hyperkalemia ( plasma K >5.5mEq/l)
14.eGFR<50mL/min/1.73 m2 during 1 month prior to the registration
15.Judged as "Imcompetent for the study" by investigators
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryozo Nagai |
Organization
University of Tokyo
Division name
Department of Cardiovascular medicine, Graduate School of Medeicine and Faculty of Medicine
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
03-3815-5411
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masao Takahashi, Yasunobu Hirata |
Organization
University of Tokyo
Division name
Department of Cardiovascular medicine, Graduate School of Medeicine and Faculty of Medicine
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
03-3815-5411
Homepage URL
masaotakahashi-gi@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo, department of cardiovascular medicine
Institute
Department
Personal name
Funding Source
Organization
Novartis Pharma K.K.
Organization
Division
Category of Funding Organization
Profit organization
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
東京大学病院(東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | 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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 04 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | 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
Management information
Registered date
| 2011 | Year | 04 | Month | 26 | Day |
Last modified on
| 2013 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006533
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
