UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001283 |
|---|---|
| Receipt number | R000001547 |
| Scientific Title | A comparison of losartan/hydrochlorothiazide vs combination therapy with an angiotensin II receptor antagonist and a calcium channel blocker in hypertensive patients with cardiac hypertrophy |
| Date of disclosure of the study information | 2008/08/01 |
| Last modified on | 2021/08/11 13:43:21 |
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Basic information
Public title
A comparison of losartan/hydrochlorothiazide vs combination therapy with an angiotensin II receptor antagonist and a calcium channel blocker in hypertensive patients with cardiac hypertrophy
Acronym
Ehime Study -Effect of Anti hypertensive therapy on Regression of Cardiac Hypertrophy (E-SEARCH)
Scientific Title
A comparison of losartan/hydrochlorothiazide vs combination therapy with an angiotensin II receptor antagonist and a calcium channel blocker in hypertensive patients with cardiac hypertrophy
Scientific Title:Acronym
Ehime Study -Effect of Anti hypertensive therapy on Regression of Cardiac Hypertrophy (E-SEARCH)
Region
| Japan |
Condition
Condition
Hypertension with cardiac hypertrophy
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effects of regression of left ventricular hypertrophy are to be compared between a fixed-dose combination drug of
losartan/hydrochlorothiazide and combination therapy of an ARB and a CCB in hypertensive patients with cardiac hypertrophy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Change in left ventricular mass index (LVMI) after 48 weeks of treatment
Key secondary outcomes
-Change in LVMI after 12 and 24 weeks of treatment
-Change and % change in systolic and diastolic blood pressure after 12, 24 and 48 weeks of treatment
-Change and % in BNP, cystatin C, microalbuminuria, Na/Creatinine ratio, aldosterone, and drug compliance after 12, 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
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Losartan/hydrochlorothiazide group
Interventions/Control_2
ARB and CCB combination grou
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) Hypertensive patients with cardiac hypertrophy, who have been previously treated with monotherapy of an ARB for more than 8 weeks, however, whose blood pressure has not been reached the target defined by the JSH2004 criteria.
2) Men and women aged 20 to 80 years
3) Outpatients
4) 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 uncontrolled hypertension (diastolic blood pressure>=110mmHg)
2) Patients with secondary hypertension
3) Patients with uncontrolled diabetes (HbA1c>=8.0%) and under treatment with insulin
4) Patients who have stroke, AMI and/or other critical vascular complications that required hospitalization within 6 months prior to the intervention
5) Patients with liver dysfunction [GPT(ALT) over three times the normal value]
6) Patients with renal failure (serum creatinine>=2.0 mg/dL)
7) Patients with a previous history of gout attack or uncontrolled hyperuricemia (>=8.0mg/dL)
8) Patients with cardiac insufficiency (NYHA grade III or IV)
9) Patients with severe malignant cancer or other unfavorable prognostic factors
10) Pregnant or possible pregnant women
11) Patients with a history of hypersensitivity to ingredients of losartan potassium or hydrochlorothiazide
12) Patients with a history of hypersensitivity to thiazide or thiazide-like diuretics
13) Patients with a history of hypersensitivity to ingredients of a calcium channel blocker to be used in the study
14) Patients who are considered not eligible for the study by the attending doctor due to medical reasons
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Jitsuo |
| Middle name | |
| Last name | Higaki |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Integrated Medicine and Informatics
Zip code
791-0295
Address
Shitsukawa, Toon-shi, Ehime-ken
TEL
089-960-5302
jhigaki@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Okura |
| Middle name | |
| Last name | Takafumi |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Integrated Medicine and Informatics
Zip code
791-0295
Address
Shitsukawa, Toon-shi, Ehime-ken
TEL
089-960-5302
Homepage URL
okura@m.ehime-u.ac.jp
Sponsor or person
Institute
Ehime hypertensive treatment study group
Institute
Department
Personal name
Funding Source
Organization
Japan Heart Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ehime University
Address
Shitsukawa Toon City
Tel
089-960-5303
okura@m.ehime-u.ac.jp
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
| 2008 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.tandfonline.com/doi/full/10.3109/10641963.2013.764892
Publication of results
Unpublished
Result
URL related to results and publications
Clinical and Experimental Hypertenison, 2013; 35: 563-569
Number of participants that the trial has enrolled
53
Results
Patients with LVH who had received the angiotensin receptor blocker (ARB) for 8 weeks and had not reached the target blood pressure level were enrolled. Patients were assigned to either losartan (50 mg)/hydrochlorothiazide (HCTZ, 12.5 mg) group or ARB + CCB group (usual dose of ARB and calcium channel blocker, CCB). After 48 weeks, LV mass index was found to be reduced significantly in the losartan/HCTZ group but not in the ARB + CCB group.
Results date posted
| 2021 | Year | 08 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2013 | Year | 08 | Month | 01 | Day |
Baseline Characteristics
Hypertensive patients aged 20-80 years with left ventricular hypertrophy who have been taking angiotensin receptor blockers for more than 8 weeks but have not reached their target blood pressure
Participant flow
These patients were divided into two groups, a losartan 50 mg + hydrochlorothiazide 12.5 mg group and an angiotensin receptor blocker normal dose + Ca channel blocker group, and the presence or absence of regression of left ventricular hypertrophy was examined 48 weeks later.
Adverse events
None
Outcome measures
After 48 weeks, LV mass index was found to be reduced significantly in the losartan/HCTZ group but not in the ARB + CCB group. These results suggest that combination therapy of an ARB and diuretic has greater potential to cause regression compared with an ARB and CCB.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2008 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2008 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2008 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2012 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 08 | Month | 01 | Day |
Last modified on
| 2021 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001547
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