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Sponsors and Collaborators: |
Karolinska Institutet Bristol-Myers Squibb Sanofi-Aventis Swedish Heart Lung Foundation |
Information provided by: | Karolinska Institutet |
ClinicalTrials.gov Identifier: | NCT00389168 |
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 w. 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.
Condition | Intervention | Phase |
Hypertension |
Drug: Irbesartan vs atenolol |
Phase II Phase III |
MedlinePlus related topics: | Heart Diseases High Blood Pressure |
ChemIDplus related topics: | Atenolol Irbesartan |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Randomized, Double-Blind Evaluation of the Effects of Irbesartan and Atenolol on Cardiovascular Structure and Function in Subjects With Hypertension and Left Ventricular Hypertrophy |
Estimated Enrollment: | 115 |
Study Start Date: | April 1995 |
Estimated Study Completion Date: | April 1997 |
We included 115 patients with hypertension and cardiac hypertrophy, established by echocardiography. Extensive echocardiographic examinations, ultrasonography of the carotid arteries, 24h Holter registrations, 24h AMP monitoring, neurohormones and blood samples for inflammation and hemostasis markers and endothelial function were done at weeks 0, 12, 24, and 48. Matched control groups (1:3, i.e. 38 normotensive subjects and 38 hypertensive subjects with no signs of hypertensive heart disease were examined at one occasion. All patients obtained irbesartan or atenolol for 12 weeks; a diuretic and a calcium antagonist was added when needed thereafter in order to obtained a blood pressure below 140/90 mm Hg. All analyses were performed central in a core laboratory.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Sweden | |||||
Karolinska Institutet, Daprtment of Clinical Sciences, Danderyd Hospital, Cardiovascular Research Laboratory | |||||
Stockholm, Sweden, SE-182 88 |
Karolinska Institutet |
Bristol-Myers Squibb |
Sanofi-Aventis |
Swedish Heart Lung Foundation |
Study Chair: | Thomas Kahan, MD, PhD | Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital, SE-182 88 Stockholm, Sweden |
Study ID Numbers: | CV131-052 |
First Received: | October 17, 2006 |
Last Updated: | October 17, 2006 |
ClinicalTrials.gov Identifier: | NCT00389168 |
Health Authority: | Sweden: Regional Ethical Review Board |
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