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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000005511
Receipt No. 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

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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 na&iuml;ve 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
Email

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
Email masaotakahashi-gi@umin.ac.jp

Sponsor
Institute The University of Tokyo, department of cardiovascular medicine
Institute
Department

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
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 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
URL(English) https://upload.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


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