Human immunodeficiency virus infection and highly active antiretroviral therapy (HAART) are associated with an increased risk of cardiovascular disease: a wide range of alterations in lipid and glucose metabolism has been increasingly recognized in HIV patients treated with HAART. Few data are available on the effects of antihypertensive treatment on cardiac morpho-functional characteristics and...
Date First Received: November 26, 2007
Last Updated: December 5, 2007
Verified by: Università degli Studi dell'Insubria, November 2007
Clinical Trial Phase: Phase 4 | Start Date: September 2007
Overall Status: Recruiting
Estimated Enrollment: 30
Brief Summary
Official Title: “Effects of Antihypertensive Treatment on Cardiac Remodelling and Metabolic Profile in HIV Infected Patients: Randomized Longitudinal Study With Candesartan Versus Lercanidipine”
Condition Keyword(s):
Intervention(s):
Human immunodeficiency virus infection and highly active antiretroviral therapy (HAART) are associated with an increased risk of cardiovascular disease: a wide range of alterations in lipid and glucose metabolism has been increasingly recognized in HIV patients treated with HAART. Few data are available on the effects of antihypertensive treatment on cardiac morpho-functional characteristics and metabolic parameters in HIV patients. Aim of the study is to assess the effects of chronic therapy with angiotensin receptor blocker(candesartan)or calcium channel blocker (lercanidipine)on metabolic profile and cardiac remodelling in HIV hypertensive patients.
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: candesartan
- tablet 8-16 mg once daily, one year
- Drug: lercanidipine
- tablets 10-20 mg once daily, one year
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- candesartan 8-16 mg once daily
- Active Comparator: 2
- lercanidipine 10-20 mg once daily
Outcome Measures for this Clinical Trial
Primary Measures
- morpho-functional left ventricle characteristics
- Time Frame: one year
- Time Frame: one year
- metabolic profile
- Time Frame: one year
- Time Frame: one year
Secondary Measures
- systolic and diastolic blood pressure
- Time Frame: one year
- Time Frame: one year
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- HIV infection
- office blood pressure > 140/90 mmHg
- no antihypertensive treatment
- good quality echocardiogram
Exclusion Criteria:
- cardiovascular diseases
- hypothyroidism
- diabetes
- secondary hypertension
- hepatic and renal failure
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 65 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Università degli Studi dell'Insubria
Overall Clinical Trial Officials and Contacts
anna maria grandi, MD Study Chair University of Insubria, Varese, ITALY
Overall Contact: anna maria grandi, MD +39 0332 278403 amgrandi@libero.it
Related Publications
References
Grinspoon SK. Metabolic syndrome and cardiovascular disease in patients with human immunodeficiency virus. Am J Med. 2005 Apr;118 Suppl 2:23S-28S. Review.
Gazzaruso C, Bruno R, Garzaniti A, Giordanetti S, Fratino P, Sacchi P, Filice G. Hypertension among HIV patients: prevalence and relationships to insulin resistance and metabolic syndrome. J Hypertens. 2003 Jul;21(7):1377-82.
Friis-Møller N, Sabin CA, Weber R, d'Arminio Monforte A, El-Sadr WM, Reiss P, Thiébaut R, Morfeldt L, De Wit S, Pradier C, Calvo G, Law MG, Kirk O, Phillips AN, Lundgren JD; Data Collection on Adverse Events of Anti-HIV Drugs (DAD) Study Group. Combination antiretroviral therapy and the risk of myocardial infarction. N Engl J Med. 2003 Nov 20;349(21):1993-2003. Erratum in: N Engl J Med. 2004 Feb 26;350(9):955.
Meng Q, Lima JA, Lai H, Vlahov D, Celentano DD, Strathdee S, Nelson KE, Tong W, Lai S. Use of HIV protease inhibitors is associated with left ventricular morphologic changes and diastolic dysfunction. J Acquir Immune Defic Syndr. 2002 Jul 1;30(3):306-10.
Lindholm LH, Persson M, Alaupovic P, Carlberg B, Svensson A, Samuelsson O. Metabolic outcome during 1 year in newly detected hypertensives: results of the Antihypertensive Treatment and Lipid Profile in a North of Sweden Efficacy Evaluation (ALPINE study). J Hypertens. 2003 Aug;21(8):1563-74.
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00564057
Study ID Number: 44758
ClinicalTrials.gov Identifier: NCT00564057
Health Authority: Italy: Ethics Committee
Clinical Trials Authorship and Review
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