![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000315 |
Receipt No. | 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 |
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 |
|
Condition | ||
Condition | Hypertensive patients undergoing trice-weekly hemodialysis | |
Classification by specialty |
|
|
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 |
|
|
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 |
|
|||
Age-upper limit |
|
|||
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 |
|
||||||
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 |
|
||||||
Organization | Rokko Island Hospital | ||||||
Division name | Div. Nephrology | ||||||
Zip code | |||||||
Address | |||||||
TEL | |||||||
Homepage URL | |||||||
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 | |
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 |
|
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 |
|
||||||
Date of IRB | |||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry |
|
||||||
Date trial data considered complete |
|
||||||
Date analysis concluded |
|
Other | |
Other related information |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
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 | |
Registered date | File name |