UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000315 |
|---|---|
| Receipt number | R000000409 |
| Scientific Title | EFFECTS of BLOOD PRESSURE LOWERING and ANTIHYPERTENSIVE DRUG CLASS on SURVIVAL and CARDIOVASCULAR EVENTS of HEMODIALYSIS PATIENTS: |
| Date of disclosure of the study information | 2006/02/01 |
| Last modified on | 2007/06/19 18:48:13 |
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Basic information
Public title
EFFECTS of BLOOD PRESSURE LOWERING and ANTIHYPERTENSIVE DRUG CLASS on SURVIVAL and CARDIOVASCULAR EVENTS of HEMODIALYSIS PATIENTS:
Acronym
Hemodialysis Heart Angiotensin-Inhibition Rescue Trial (HHEART) Randomized Clinical Trial
Scientific Title
EFFECTS of BLOOD PRESSURE LOWERING and ANTIHYPERTENSIVE DRUG CLASS on SURVIVAL and CARDIOVASCULAR EVENTS of HEMODIALYSIS PATIENTS:
Scientific Title:Acronym
Hemodialysis Heart Angiotensin-Inhibition Rescue Trial (HHEART) Randomized Clinical Trial
Region
| Japan |
Condition
Condition
Hypertensive patients undergoing trice-weekly hemodialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A strict blood pressure control and/or usage of an ACE inhibitor may reduce all-casue mortality in Hypertensive patients undergoing trice-weekly hemodialysis.
Basic objectives2
Others
Basic objectives -Others
Cardiovascular mortality and morbidity
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
death from all causes
Key secondary outcomes
CVD (atherosclerotic heart disease including acute myocardial infarction, cardiomyopathy, cerebrovascular accident, cardiac arrhythmia and cardiac arrest of unknown causes) and first hospitalization for fetal and non fetal CVD events.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Enrolled patients were randomly assigned with a two-by-two factorial design to either 1 of 2 levels of pre-dialytic mean arterial pressure (BP) goals, 105 to 110 mmHg (usual BP group, around 140/90 mmHg) or 95 mmHg or less (lower BP group, equal to or less than 135/75 mmHg). To achieve the target pre-dialysis MAP goals, we conducted multiple and intensive nonpharmacological and pharmacological treatment, including request of recording of home blood pressure monitoring and diet-diary with specialists' consultation, repeated confirmation of patients' dry weight, a longer dialysis session including ultrafiltration, add-on of open-label antihypertensive agents (alfa-adrenergic antagonists, direct-acting vasodilator, beta-adrenergic antagonists, centrally acting adrenergic agents, and alfa--methyldopa), correction of anemia (less than 33 percent), and treatment of serum calcium and phosphorus abnormalities (surgical treatment, if necessary).
Interventions/Control_2
Enrolled patients were randomly assigned with a two-by-two factorial design to initial antihypertensive treatment with either amlodipine or trandolapril. ACE inhibitors (or ARBs) or CCBs were stopped 2 weeks before randomization. Initial dose of trandolapril of 0.25 mg or amlodipine of 2.5 mg per day were administrated at inter-dialysis night and then were up-titrated individually to be maximum tolerated. To keep the drug class intervention blinded, the study drug was prepared separately from other drugs and placed within opaque paper envelop, which obscured the drug inside.
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
| 23 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Hypertensive patients, 23 to 70 years of age, all Japanese, who were undergoing outpatient hemodialysis thrice weekly for three or more months were enrolled between January 1996 and December 1999. Hypertension was defined as averaged office pre-dialysis BP at sitting position of 150/90 mm Hg or more with or without antihypertensive medications for a minimum of three month before randomization.
Key exclusion criteria
patients with preserved residual renal function (urine volume of more than 500 mL per day), pre-dialysis BP of less than 140/60 mm Hg, unstable homodynamic during hemodialysis therapy, a history of drug-allergy, accelerated or malignant hypertension within six months, secondary hypertension, severe systemic diseases, including cardio-,cerebro- and peripheral vascular, pulmonary, and gastrointestinal and hepatic diseases.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | NAOYUKI NAKAO |
Organization
Rokko Island Hospital
Division name
Div. Nephrology
Zip code
Address
Koh-Yoh chou Naka 2-11, HIgashinada, Kobe
TEL
078-858-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | NAOYUKI NAKAO |
Organization
Rokko Island Hospital
Division name
Div. Nephrology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Div. Nephrology, GenGen-Do Kimitsu Hospital
Institute
Department
Personal name
Funding Source
Organization
GenGenDo Clinical Research Found
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2006 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 1996 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 1996 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2003 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2003 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2004 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2005 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 01 | Month | 29 | Day |
Last modified on
| 2007 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000409
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