Cardiovascular Diseases in HIV-infected Subjects (HIV-HEART Study)

NCT01119729 | Completed DMC

• 1 other identifier: FKZ 01GI0205
• Study Type: observational
• Target: 803
• Locations: 1 country
• Sites: 7

Brief Summary

Human immunodeficiency virus (HIV) infection has been associated with a variety of cardiovascular diseases. Even most industrialised countries exhibit a growing and aging population of HIV-infected patients in the majority treated with antiretroviral drugs, the investigators still do not know much about the impact of cardiovascular diseases in this group of patients. The present study is an ongoing trial that was conducted as a prospective and multicentre survey, being schemed to analyse the frequency and clinical course of cardiac disorders in HIV-infected patients.

Conditions

Detection of Frequency, Severity and Progression of Cardiovascular Diseases in Patients With HIV-infection.; Effect on Cardiovascular Risk and Life Quality by Age, Gender, Classic Cardiovascular Risk Factors,; HIV-specific Cardiovascular Risk Factors, Cardiovascular Medication, Antiretroviral Medication

Keywords

Cardiac Diseases • HIV-Infection • AIDS • Antiretroviral Therapy

Outcome Measures

Primary Outcomes (1)

• Prevalence of cardiovascular diseases

  Prevalence of cardiovascular diseases including coronary artery disease, congestive heart failure, peripheral arterial disease, cerebrovascular events, and valvular diseases.

Secondary Outcomes (1)

• Prevalence of cardiovascular disorders

Study Arms (1)

HIV-infected Outpatients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population included outpatients who were at least 18 years of age, had a known HIV-infection and exhibited a stable disease status within 4 weeks before inclusion of the trial. Patients were recruited during a 20-month period in a consecutive manner from September 2004 to May 2006. Written informed consent was obtained from all participants

You may qualify if:

• Age \> 18 years
• Known HIV-infection
• Outpatients
• Written informed consent

You may not qualify if:

• Pregnancy

Sponsors & Collaborators

• University Hospital, Essen: lead
• Federal Ministry of Education and Reserach (BMBF): collaborator

Study Sites (7)

Department of Dermatology, University Hospital of Bochum

Bochum, North Rhine-Westphalia, 44791, Germany

Location

HIV Outpatient Department

Dortmund, North Rhine-Westphalia, 44137, Germany

Location

HIV Outpatients Department

Duisburg, North Rhine-Westphalia, 47055, Germany

Location

HIV Outpatient Department

Duisburg, North Rhine-Westphalia, 47259, Germany

Location

Department of Dermatology, University Hospital of Essen

Essen, North Rhine-Westphalia, 45122, Germany

Location

West German Heart Center Essen

Essen, North Rhine-Westphalia, 45122, Germany

Location

HIV Outpatient Department

Essen, North Rhine-Westphalia, 45127, Germany

Location

Related Publications (8)

• Neumann T, Esser S, Potthoff A, Pankuweit S, Neumann A, Breuckmann F, Neuhaus K, Kondratieva J, Buck T, Muller-Tasch T, Wachter R, Prettin C, Gelbrich G, Herzog W, Pieske B, Rauchhaus M, Loffler M, Maisch B, Mugge A, Wasem J, Gerken G, Brockmeyer NH, Erbel R; HIV-HEART Study Investigative Group. Prevalence and natural history of heart failure in outpatient HIV-infected subjects: rationale and design of the HIV-HEART study. Eur J Med Res. 2007 Jun 27;12(6):243-8.

  PMID: 17666313 BACKGROUND

• Neumann T. [HIV, AIDS and the cardiovascular risk]. Internist (Berl). 2008 Apr;49(4):429-30, 432-5. doi: 10.1007/s00108-008-2049-4. German.

  PMID: 18305915 RESULT

• Reinsch N, Buhr C, Krings P, Kaelsch H, Kahlert P, Konorza T, Neumann T, Erbel R; Competence Network of Heart Failure. Effect of gender and highly active antiretroviral therapy on HIV-related pulmonary arterial hypertension: results of the HIV-HEART Study. HIV Med. 2008 Aug;9(7):550-6. doi: 10.1111/j.1468-1293.2008.00602.x. Epub 2008 Jun 28.

  PMID: 18557952 RESULT

• Reinsch N, Buhr C, Krings P, Kaelsch H, Neuhaus K, Wieneke H, Erbel R, Neumann T; German Heart Failure Network. Prevalence and risk factors of prolonged QTc interval in HIV-infected patients: results of the HIV-HEART study. HIV Clin Trials. 2009 Jul-Aug;10(4):261-8. doi: 10.1310/hct1004-261.

  PMID: 19723613 RESULT

• Neumann T, Reinsch N, Neuhaus K, Brockmeyer N, Potthoff A, Esser S, Hower M, Neumann A, Mostardt S, Gelbrich G, Erbel R; fur die HIV-HEART-Studie sowie die Kompetenznetze Herzinsuffizienz und HIV/AIDS. [BNP in HIV-infected patients]. Herz. 2009 Dec;34(8):634-40. doi: 10.1007/s00059-009-3313-7. German.

  PMID: 20024643 RESULT

• Reinsch N, Esser S, Gelbrich G, Brockmeyer N, Potthoff A, Schadendorf D, Erbel R, Neumann T. Valvular manifestations of human immunodeficiency virus infection--results from the prospective, multicenter HIV-HEART study. J Cardiovasc Med (Hagerstown). 2013 Oct;14(10):733-9. doi: 10.2459/JCM.0b013e32835dc953.

  PMID: 24335884 DERIVED

• Esser S, Gelbrich G, Brockmeyer N, Goehler A, Schadendorf D, Erbel R, Neumann T, Reinsch N. Prevalence of cardiovascular diseases in HIV-infected outpatients: results from a prospective, multicenter cohort study. Clin Res Cardiol. 2013 Mar;102(3):203-13. doi: 10.1007/s00392-012-0519-0. Epub 2012 Nov 2.

  PMID: 23117698 DERIVED

• Reinsch N, Kahlert P, Esser S, Sundermeyer A, Neuhaus K, Brockmeyer N, Potthoff A, Erbel R, Buck T, Neumann T. Echocardiographic findings and abnormalities in HIV-infected patients: results from a large, prospective, multicenter HIV-heart study. Am J Cardiovasc Dis. 2011;1(2):176-84. Epub 2011 Jul 30.

  PMID: 22254197 DERIVED

MeSH Terms

Conditions

Coitus

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 7, 2010
• First Posted: May 10, 2010
• Last Updated: May 10, 2010

Record last verified: 2010-05

Locations

DE (7)