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

NCT00564057 | Unknown Phase 4

• 1 other identifier: 44758
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; Hypertension

Keywords

HIV; blood pressure; left ventricle; metabolic profile; treatment experienced

Outcome Measures

Primary Outcomes (2)

• morpho-functional left ventricle characteristics

  one year

• metabolic profile

  one year

Secondary Outcomes (1)

• systolic and diastolic blood pressure

  one year

Study Arms (2)

1

EXPERIMENTAL

candesartan 8-16 mg once daily

Drug: candesartan

2

ACTIVE COMPARATOR

lercanidipine 10-20 mg once daily

Drug: lercanidipine

Interventions

candesartan DRUG

tablet 8-16 mg once daily, one year

1

lercanidipine DRUG

tablets 10-20 mg once daily, one year

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV infection
• office blood pressure \> 140/90 mmHg
• no antihypertensive treatment
• good quality echocardiogram

You may not qualify if:

• cardiovascular diseases
• hypothyroidism
• diabetes
• secondary hypertension
• hepatic and renal failure

Sponsors & Collaborators

• Università degli Studi dell'Insubria: lead

Study Sites (1)

University of Insubria, Department of Clinical Medicine

Varese, 21100, Italy

RECRUITING

Related Publications (5)

• 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.

  PMID: 15903292 BACKGROUND

• 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.

  PMID: 12817187 BACKGROUND

• 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.

  PMID: 14627784 BACKGROUND

• 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.

  PMID: 12131567 BACKGROUND

• 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.

  PMID: 12872052 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Hypertension

Interventions

candesartan; lercanidipine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• anna maria grandi, MD

  University of Insubria, Varese, ITALY

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

anna maria grandi, MD

CONTACT

+39 0332 278403; amgrandi@libero.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 26, 2007
• First Posted: November 27, 2007
• Study Start: September 1, 2007
• Study Completion: September 1, 2009
• Last Updated: December 6, 2007

Record last verified: 2007-11

Locations

IT (1)