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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00564057
• Other study ID #: 44758
• Status: Recruiting
• Phase: Phase 4
• First received: November 26, 2007
• Last updated: December 5, 2007
• Start date: September 2007
• Est. completion date: September 2009

Study information

• Verified date: November 2007
• Source: Università degli Studi dell'Insubria
• Contact: anna maria grandi, MD
• Phone: +39 0332 278403
• Email: amgrandi[@]libero.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Hypertension

Intervention

Drug:
• candesartan
tablet 8-16 mg once daily, one year
• lercanidipine
tablets 10-20 mg once daily, one year

Locations

Country	Name	City	State
Italy	University of Insubria, Department of Clinical Medicine	Varese

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi dell'Insubria

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. — View 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. — View Citation

Grinspoon SK. Metabolic syndrome and cardiovascular disease in patients with human immunodeficiency virus. Am J Med. 2005 Apr;118 Suppl 2:23S-28S. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	morpho-functional left ventricle characteristics		one year
Primary	metabolic profile		one year
Secondary	systolic and diastolic blood pressure		one year