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

UMIN ID: C000000315

Registered date:01/02/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Hypertensive patients undergoing trice-weekly hemodialysis
• Date of first enrollment: 1996/04/01
• Target sample size: 400
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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).
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.

Outcome(s)

• Primary Outcome: death from all causes
• Secondary Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: 23years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Div. Nephrology, GenGen-Do Kimitsu Hospital
• Source(s) of Monetary Support: GenGenDo Clinical Research Found