Clinical trial NCT00564057: Effects of Antihypertensive Treatment in HIV Infected Patients: Candesartan Versus Lercanidipine
Official title: Effects of Antihypertensive Treatment on Cardiac Remodelling and Metabolic Profile in HIV Infected Patients: Randomized Longitudinal Study With Candesartan Versus Lercanidipine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: HIV Infections
Hypertension
Keywords: HIV
blood pressure
left ventricle
metabolic profile
treatment experienced
Lead sponsor: Università degli Studi dell'Insubria
Sponsor class: OTHER
First posted: 2007-11-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: morpho-functional left ventricle characteristics
timeFrame: one year
measure: metabolic profile
timeFrame: one year
Secondary outcomes:
measure: systolic and diastolic blood pressure
timeFrame: one year
Other outcomes:
Locations:
city: Varese
country: Italy
facility: University of Insubria, Department of Clinical Medicine
Study officials:
affiliation: University of Insubria, Varese, ITALY
name: anna maria grandi, MD
role: STUDY_CHAIR
affiliation: University of Insubria, Varese, Italy
name: paolo grossi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Insubria, Varese, Italy
name: andrea maria maresca, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Insubria, Varese, Italy
name: eleonora nicolini, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Insubria, Varese, Italy
name: massimo giola, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grinspoon SK. Metabolic syndrome and cardiovascular disease in patients with human immunodeficiency virus. Am J Med. 2005 Apr;118 Suppl 2:23S-28S. doi: 10.1016/j.amjmed.2005.01.047.
citation: 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. doi: 10.1097/01.hjh.0000059071.43904.dc.
citation: Friis-Moller N, Sabin CA, Weber R, d'Arminio Monforte A, El-Sadr WM, Reiss P, Thiebaut 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. doi: 10.1056/NEJMoa030218.
citation: 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. doi: 10.1097/00126334-200207010-00006.
citation: 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. doi: 10.1097/01.hjh.0000084723.53355.76.