UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002487 |
|---|---|
| Receipt number | R000003047 |
| Scientific Title | The effect of aggressive antihypertensive therapy in hypertensive patients with left ventricular diastolic dysfunction |
| Date of disclosure of the study information | 2009/11/01 |
| Last modified on | 2018/03/21 10:44:14 |
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Basic information
Public title
The effect of aggressive antihypertensive therapy in hypertensive patients with left ventricular diastolic dysfunction
Acronym
The effect of aggressive antihypertensive therapy in hypertensive patients with left ventricular diastolic dysfunction
Scientific Title
The effect of aggressive antihypertensive therapy in hypertensive patients with left ventricular diastolic dysfunction
Scientific Title:Acronym
The effect of aggressive antihypertensive therapy in hypertensive patients with left ventricular diastolic dysfunction
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effect of a combination drug of an angiotenshin II receptor blockers (ARB) and a low-dose diuretic vs combination therapy with an ARB and an angiotensin converting enzyme (ACE) inhibitor in hypertensive patients with left ventricular diastolic dysfunction. In addition to the effect on left ventricular diastolic dysfunction, the study aims to evaluate the efficacy on myocardial hypertrophy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Change and % change in left ventricular hypertrophy and left ventricular diastolic function after 48 weeks of treatment
Key secondary outcomes
- Change and % change in left ventricular hypertrophy and left ventricular diastolic function after 24 weeks of treatment
- Change and % change in blood pressure after 4, 24 and 48 weeks of treatment
- Change and % change in BNP, cathecholamine 3 fractionation, hs-CRP, plasma renin activity and aldosterone levels after 24 and 48 weeks of treatment
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
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Losartan/HCTZ group
Interventions/Control_2
Losartan (50mg) and Enalapril (5mg) combination group
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
Inclusion criteria:
1) Outpatients (men and women) aged 20 to 80 years at the time of the first visit
2) Patients with hypertension, who have been previously treated with monotherapy of a standard-dose of ARB for more than 1 month, however, whose blood pressure has not been adequately controlled (systolic blood pressure>=140mmHg and/or diastolic blood pressure>=90mmHg)
3) Patients who fully understand the study procedures explained to them using explanatory notes and have given written informed consent to participate in the study
Key exclusion criteria
Exclusion criteria:
1) Patients with secondary hypertension
2) Patients with uncontrolled hypertension (DBP>=120mmHg)
3) Patients with uncontrolled diabetes (HbA1c>=8.0%)
4) Patients with cardiac insufficiency (over NYHA grade III)
5) Patients with renal failure (serum creatinine>=2.0mg/dl)
6) Patients with liver dysfunction (GOT or GPT>=100IU/L)
7) Patients with a previous history of gout attack or uncontrolled hyperuricemia (UA>=8.0mg/dl)
8) Patients with hyperkalemia (K>=5.5mEq/L)
9) Pregnant or breast feeding female patients, including one trying to conceive pregnancy during the planned study period
10) Patients with a history of hypersensitivity to ingredients of the study drugs
11) Patients who are considered not eligible for the study by the attending doctor due to medical reasons
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoji Neishi |
Organization
Kawasaki Medical School
Division name
Division of Cardiology
Zip code
Address
577 Matsushima, Kurashiki, Okayama 701-0192, Japan
TEL
086-462-1111
neishi@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoji Neishi |
Organization
Kawasaki Medical School
Division name
Division of Cardiology
Zip code
Address
577 Matsushima, Kurashiki, Okayama 701-0192, Japan
TEL
086-462-1111
Homepage URL
neishi@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
川崎医科大学 （岡山県）
Kawasaki Medical School (Okayama)
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 11 | 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
Completed
Date of protocol fixation
| 2009 | Year | 04 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 09 | Month | 13 | Day |
Last modified on
| 2018 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003047
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