UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001257 |
|---|---|
| Receipt number | R000001529 |
| Scientific Title | Hokkaido-Losartan/hydrochlorothiazide Investigation For End Point (H-LIFE study): Multi-center observational study on blood pressure control and cardio- and renoprotective effects of an ARB / diuretic combination in hypertensive patients in Hokkaido, Japan |
| Date of disclosure of the study information | 2008/07/22 |
| Last modified on | 2014/01/22 20:35:21 |
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Basic information
Public title
Hokkaido-Losartan/hydrochlorothiazide Investigation For End Point (H-LIFE study):
Multi-center observational study on blood pressure control and cardio- and renoprotective effects of an ARB / diuretic combination in hypertensive patients in Hokkaido, Japan
Acronym
H-LIFE study
:Hokkaido-Losartan/hydrochlorothiazide Investigation For End Point
Scientific Title
Hokkaido-Losartan/hydrochlorothiazide Investigation For End Point (H-LIFE study):
Multi-center observational study on blood pressure control and cardio- and renoprotective effects of an ARB / diuretic combination in hypertensive patients in Hokkaido, Japan
Scientific Title:Acronym
H-LIFE study
:Hokkaido-Losartan/hydrochlorothiazide Investigation For End Point
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1) To evaluate anti-hypertensive effect of losartan/HCTZ (Preminent), focusing on blood pressure control and cardio- and renoprotective effects.
2) To identify a group of patients with good response to losartan/HCTZ treatment by conducting a subgroup analysis of patients with cardiac- and renal complications.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1.Change in office blood-pressure
2.Change in BNP and NT-proBNP levels
3.Change in microalbuminuria, proteinuria and renal function
Key secondary outcomes
1.Frequency of cardiovascular events (fatal and non-fatal myocardial infarction, unstable angina, angina that required hospitalization, coronary revascularization, stroke etc)
2.Frequency of renal events (end-stage renal disease [ESRD], deterioration in renal function, etc)
3.Mortality
4.Rates of adverse events
5.Exploratory subgroup analysis
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Hypertensive patients for whom treatment with Preminent is planned since their blood pressure has not reached the target levels (SBP <140 mmHg and DBP <90mmHg; SBP <130 mmHg and DBP <80mmHg if patients are 65 years or younger, with chronic kidney disease or diabetes, or with a previous history of cardiovascular disease)
2)Men and women aged 20 years or older
3)Both outpatients and inpatients
4)Patients who fully understand study procedures and have given written informed consent to participate in the study
Key exclusion criteria
1)Patients with a history of hypersensitivity to ingredients of losartan/HCTZ
2)Patients with a history of hypersensitivity to thiazide or thiazide-like diuretics
3)Pregnant (positive on a urine pregnancy test prior to the study) or breast feeding female patients, including one trying to conceive pregnancy during the planned study period
4)Patients with sever liver dysfunction
5)Patients with anuria or on dialysis
6)Patients with acute renal failure
7)Patients whose sodium and potassium levels in body fluids are clearly decreased
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Tsutsui |
Organization
Hokkaido Clinical Hypertension Research Group
(Hokkaido University Graduate School of Medicine)
Division name
Cardiovascular Medicine
Zip code
Address
Kita 15, Nishi 7, Kita-ku, Sapporo, Japan
TEL
011-706-6973
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisako Fujimoto |
Organization
H-LIFE research secretariat
Division name
H-LIFE research secretariat
Zip code
Address
Yushima 1-chome Bldg., 1-6-3 Yushima, Bunkyo-ku, Tokyo 113-0034, Japan
TEL
03-3814-9393
Homepage URL
H-LIFE@n-place.co.jp
Sponsor or person
Institute
Hokkaido Clinical Hypertension Research 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
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
| 2008 | Year | 07 | Month | 22 | 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
| 2008 | Year | 02 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 01 | Day |
Other
Other related information
Prospective observational study
Management information
Registered date
| 2008 | Year | 07 | Month | 21 | Day |
Last modified on
| 2014 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001529
