Irbesartan and Atenolol in Hypertensive Heart Disease (SILVHIA)
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ClinicalTrials.gov Identifier: NCT00389168 |
Recruitment Status :
Completed
First Posted : October 18, 2006
Results First Posted : May 5, 2015
Last Update Posted : May 5, 2015
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertension | Drug: Irbesartan Drug: Atenolol | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 115 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
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 |
Study Start Date : | April 1995 |
Actual Primary Completion Date : | April 1997 |
Actual Study Completion Date : | April 1997 |

Arm | Intervention/treatment |
---|---|
Experimental: Irbesartan
Irbesartan per os titrated to 300 mg od, 48 weeks
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Drug: Irbesartan
Titrated to 300 mg od, 48 weeks.
Other Name: Aprovel |
Active Comparator: Atenolol
Atenolol per os titrated to 100 mg od, 48 weeks
|
Drug: Atenolol
Titrated to 100 mg od, 48 weeks.
Other Name: Tenormin |
- Changes in Left Ventricular Mass Index [ Time Frame: Baseline and 48 weeks ]Repeated measures multivariate analysis of variance (MANOVA) at time points 0, 12, 24, and 48 weeks. Data are presented as left ventricular mass in gram (g) indexed for body mass index (in m^2).
- Number of Participants With Serious Adverse Events [ Time Frame: Treatment period was baseline to 48 weeks ]Safety was assessed by non-directed questions, and all observed and volunteered adverse events were recorded at each study visit. Serious adverse events were defined by, and reported according to the regulations of good clinical practice (GCP). none were considered related to the study medication.
- Left Ventricular Diastolic Function Assessed by the E/A Ratio [ Time Frame: Baseline to 48 weeks ]Changes in left ventricular diastolic function from baseline to week 48 will be evaluated as the difference in E/A ratio. Conventional pulsed wave Doppler echocardiography was used for recordings of mitral inflow in. The peak of early (E) and late (A) mitral flow velocities were measured, and the E/A-ratio was calculated. Repeated measures MANOVA at time points 0, 12, 24, and 48 weeks. Some echocardiographic recordings at some time point may be of insufficient quality or missing, and the number of observations may not always correspond to the total number of participants at all time points.
- Blood Pressure [ Time Frame: Baseline to 48 weeks ]Difference in Diastolic Blood Pressure. Repeated measures multivariable analysis of variance (MANOVA) at time points 0, 12, 24, and 48 weeks
- Changes of Venous Plasma Angiotensin II as a Marker of the Renin-Angiotensin-Aldosterone System [ Time Frame: Baseline to 48 weeks ]Venous plasma concentrations of angiotensin II were measured in order to study the possible associations between the activity of the renin-angiotensin-aldosteone system and changes in left ventricular mass. Further analyses of other components of the renin-angiotensin-aldosterone system and of other hormonal system (e.g. the sympathetic nervous system) have also been performed and published. Repeated measures MANOVA at time points 0, 12, 24, and 48 weeks. Data were log-transformed to avoid skewness before statistical evaluation. However, tabular data are given as mean values with 95% confidence to improve readability.
- Effects on Carotid Artery Wall Thickness [ Time Frame: Baseline to 48 weeks ]Changes in common carotid artery intima-media thickness, assessed by ultrasonography.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00389168
Sweden | |
Karolinska Institutet, Daprtment of Clinical Sciences, Danderyd Hospital, Cardiovascular Research Laboratory | |
Stockholm, Sweden, SE-182 88 |
Study Chair: | Thomas Kahan, MD, PhD | Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital, SE-182 88 Stockholm, Sweden |
Responsible Party: | Thomas Kahan, Professor, Principal investigator and Study Chair, Karolinska Institutet |
ClinicalTrials.gov Identifier: | NCT00389168 |
Other Study ID Numbers: |
CV131-052 |
First Posted: | October 18, 2006 Key Record Dates |
Results First Posted: | May 5, 2015 |
Last Update Posted: | May 5, 2015 |
Last Verified: | May 2015 |
Hypertension Cardiac hypertrophy Angiotensin Human |
Hypertension Vascular Diseases Cardiovascular Diseases Atenolol Irbesartan Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action Anti-Arrhythmia 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 |