| November 26, 2007 |
| December 5, 2007 |
| September 2007 |
| |
- morpho-functional left ventricle characteristics [ Time Frame: one year ]
- metabolic profile [ Time Frame: one year ]
|
| Same as current |
| Complete list of historical versions of study NCT00564057 on ClinicalTrials.gov Archive Site |
| systolic and diastolic blood pressure [ Time Frame: one year ] |
| Same as current |
| |
| Effects of Antihypertensive Treatment in HIV Infected Patients: Candesartan Versus Lercanidipine |
| Effects of Antihypertensive Treatment on Cardiac Remodelling and Metabolic Profile in HIV Infected Patients: Randomized Longitudinal Study With Candesartan Versus Lercanidipine |
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. |
| |
| Phase IV |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
- HIV Infections
- Hypertension
|
- Drug: candesartan
- Drug: lercanidipine
|
- Experimental: candesartan 8-16 mg once daily
- Active Comparator: lercanidipine 10-20 mg once daily
|
- 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.
|
| |
| Recruiting |
| 30 |
| September 2009 |
|
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
|
| Both |
| 18 Years to 65 Years |
| No |
|
|
| Italy |
| |
| NCT00564057 |
|
| 44758 |
| Università degli Studi dell'Insubria |
|
| 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 |
|
|
| Università degli Studi dell'Insubria |
| November 2007 |