Effects of Antihypertensive Treatment in HIV Infected Patients: Candesartan Versus Lercanidipine

Condition(s) targeted: HIV Infections; Hypertension

Intervention: candesartan (Drug); lercanidipine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Università degli Studi dell'Insubria

Official(s) and/or principal investigator(s):
anna maria grandi, MD, Study Chair, Affiliation: University of Insubria, Varese, ITALY
paolo grossi, MD, Principal Investigator, Affiliation: University of Insubria, Varese, Italy
andrea maria maresca, MD, Principal Investigator, Affiliation: University of Insubria, Varese, Italy
eleonora nicolini, MD, Principal Investigator, Affiliation: University of Insubria, Varese, Italy
massimo giola, MD, Principal Investigator, Affiliation: University of Insubria, Varese, Italy

Overall contact:
anna maria grandi, MD, Phone: +39 0332 278403, Email: amgrandi@libero.it

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.

Official title: Effects of Antihypertensive Treatment on Cardiac Remodelling and Metabolic Profile in HIV Infected Patients: Randomized Longitudinal Study With Candesartan Versus Lercanidipine

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

morpho-functional left ventricle characteristics

metabolic profile

Secondary outcome: systolic and diastolic blood pressure

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

anna maria grandi, MD, Phone: +39 0332 278403, Email: amgrandi@libero.it

University of Insubria, Department of Clinical Medicine, Varese 21100, Italy; Recruiting

Related publications:

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.

Starting date: September 2007
Ending date: September 2009
Last updated: December 5, 2007