Irbesartan and Atenolol in Hypertensive Heart Disease - Full Text View

Sponsor:	Karolinska Institutet
Collaborators:	Bristol-Myers Squibb Sanofi-Aventis Swedish Heart Lung Foundation
Information provided by:	Karolinska Institutet
ClinicalTrials.gov Identifier:	NCT00389168

Purpose

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Heart Diseases High Blood Pressure

Drug Information available for: Atenolol Irbesartan

U.S. FDA Resources

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:

Safety and tolerability of irbesartan compared to atenolol

Secondary Outcome Measures:

Compare changes in left ventricular mass
Evaluate changes in diastolic function
Compare changes in blood pressure
Examine the relationship between changes in left ventricular mass and sympathetic influence, and influence of the renin-angiotensin-aldosterone system
Compare the effects on carotid artery wall thickness

Estimated Enrollment:	115
Study Start Date:	April 1995
Estimated Study Completion Date:	April 1997

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00389168

Locations

Sweden
Karolinska Institutet, Daprtment of Clinical Sciences, Danderyd Hospital, Cardiovascular Research Laboratory
Stockholm, Sweden, SE-182 88

Sponsors and Collaborators

Karolinska Institutet

Bristol-Myers Squibb

Sanofi-Aventis

Swedish Heart Lung Foundation

Investigators

Study Chair:

Thomas Kahan, MD, PhD

Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital, SE-182 88 Stockholm, Sweden

More Information

Publications:

Malmqvist K, Kahan T, Edner M, Held C, Hagg A, Lind L, Muller-Brunotte R, Nystrom F, Ohman KP, Osbakken MD, Ostergern J. Regression of left ventricular hypertrophy in human hypertension with irbesartan. J Hypertens. 2001 Jun;19(6):1167-76.

ClinicalTrials.gov Identifier:	NCT00389168 History of Changes
Other Study ID Numbers:	CV131-052
Study First Received:	October 17, 2006
Last Updated:	October 17, 2006
Health Authority:	Sweden: Regional Ethical Review Board

Keywords provided by Karolinska Institutet:

Hypertension
Cardiac hypertrophy
Angiotensin
Human

Additional relevant MeSH terms:

Hypertension
Hypertrophy
Hypertrophy, Left Ventricular
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Cardiomegaly
Heart Diseases
Atenolol
Irbesartan
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on February 09, 2012