Effects of Antihypertensive Treatment in HIV Infected Patients: Candesartan Versus Lercanidipine
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 candesartan 8-16 mg once daily |
Drug: candesartan
tablet 8-16 mg once daily, one year
|
| Active Comparator: 2 lercanidipine 10-20 mg once daily |
Drug: lercanidipine
tablets 10-20 mg once daily, one year
|
Outcome Measures
Primary Outcome Measures
- morpho-functional left ventricle characteristics [one year]
- metabolic profile [one year]
Secondary Outcome Measures
- systolic and diastolic blood pressure [one year]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Insubria, Department of Clinical Medicine | Varese | Italy | 21100 |
Sponsors and Collaborators
- Università degli Studi dell'Insubria
Investigators
- Study Chair: anna maria grandi, MD, University of Insubria, Varese, ITALY
- Principal Investigator: paolo grossi, MD, University of Insubria, Varese, Italy
- Principal Investigator: andrea maria maresca, MD, University of Insubria, Varese, Italy
- Principal Investigator: eleonora nicolini, MD, University of Insubria, Varese, Italy
- Principal Investigator: massimo giola, MD, University of Insubria, Varese, Italy
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- Grinspoon SK. Metabolic syndrome and cardiovascular disease in patients with human immunodeficiency virus. Am J Med. 2005 Apr;118 Suppl 2:23S-28S. Review.
- 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.
- 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.
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