UMIN-CTR Clinical Trial

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
Email

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
Email

Sponsor
Institute	Div. Nephrology, GenGen-Do Kimitsu Hospital
Institute
Department

Funding Source
Organization	GenGenDo Clinical Research Found
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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IRB Contact (For public release)
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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
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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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000409

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
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