PHARES Study: Management of Resistant Hypertension

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the efficacy of two different treatment regimens for treating resistant hypertension previously uncontrolled with at least 3 antihypertensive treatments. The study hypothesis is that these two regimens (one based on increasing diuretics and the other based on increasing renin angiotensin system blockage) may not differ in terms of efficacy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Amlodipine; Hydrochlorothiazide; Irbesartan

Criteria

Inclusion Criteria:

• Primary hypertension

• Resistant hypertension defined by mean day-time SBP > 135 mmHg and DBP > 85 mmHg (determined with ABPM device) after a standardized 4-week regimen including irbesartan, amlodipine and HCTZ.

Exclusion Criteria:

• Secondary hypertension

• Unstable angina, history of stroke or coronary heart disease (coronary by-pass or angioplasty) in the previous 3 months

• History of cough with ACEi or gynecomastia with antialdosterones

• Heart failure (New York Heart Association [NYHA] III-IV)

• Contraindication to beta blockers because of bronchopathy or auriculoventricular block

• Diabetes mellitus (type 1 or 2) with HbA1C > 8%

• Renal failure with creatinine clearance < 40ml/min (COCKROFT evaluation)

• Arm circumference > 42 cm