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EFFECTS of BLOOD PRESSURE LOWERING and ANTIHYPERTENSIVE DRUG CLASS on SURVIVAL and CARDIOVASCULAR EVENTS of HEMODIALYSIS PATIENTS:

EFFECTS of BLOOD PRESSURE LOWERING and ANTIHYPERTENSIVE DRUG CLASS on SURVIVAL and CARDIOVASCULAR EVENTS of HEMODIALYSIS PATIENTS: - Hemodialysis Heart Angiotensin-Inhibition Rescue Trial (HHEART) Randomized Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-C000000315
Enrollment
400
Registered
2006-02-01
Start date
1996-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertensive patients undergoing trice-weekly hemodialysis

Interventions

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 mm
consultation, repeated confirmation of patients&#39
dry weight, a longer dialysis session including ultrafiltration, add-on of open-label antihypertensive agents (alfa-adrenergic antagonists, direct-acting vasodilator, beta-adrenergic antagonists, cent

Sponsors

Div. Nephrology, GenGen-Do Kimitsu Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
death from all causes

Secondary

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactNAOYUKI NAKAO

Rokko Island Hospital Div. Nephrology

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026