Overview

Irbesartan and Atenolol in Hypertensive Heart Disease

Status:
Completed
Trial end date:
1997-04-01
Target enrollment:
0
Participant gender:
All
Summary
The renin-angiotensin-aldosterone system has been implicated in the control of structural changes of the heart and the vasculature, beyond the effects on blood pressure. This projects examines the importance of the renin-angiotensin-aldosterone system and the sympathetic nervous system in the control of cardiac and vascular structure and function in subjects with hypertension.Patients with hypertension and left ventricular hypertrophy were randomized to an angiotensin receptor blocker or a beta adrenergic receptor blocker for 48 weeks. Repeat investigations of blood pressure, structure and function of the heart and the vascular tree, and neurohormones were performed. Two control groups, consisting of normotensive subjects and of hypertensive subjects with no cardiac hypertrophy were also examined for comparison.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Karolinska Institutet
Collaborators:
Bristol-Myers Squibb
Sanofi
Swedish Heart Lung Foundation
Treatments:
Atenolol
Irbesartan
Criteria
Inclusion Criteria:

- At least 18 ys old

- Male or female with no child bearing potential

- Seated blood pressure diastolic 90-115 mm Hg

- Left ventricular mass above 131 g/m2 for men, above 100 g/m2 for women

- Informed consent

Exclusion Criteria:

- Coronary artery disease, heart failure or other significant cardiac disorder

- Cerebrovascular accident within the past 6 months

- A seated systolic blood pressure above 200 mm Hg

- Significant renal disease, collagen or vascular disease, or gastrointestinal condition

- Significant allergy or intolerance to study drug

- Alcohol or drug abuse

- Uncontrolled diabetes mellitus