Cardiovascular Diseases in HIV-infected Subjects (HIV-HEART Study) - Full Text View

Purpose

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.

Condition
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


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by University Hospital, Essen:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Prevalence of cardiovascular disorders
Prevalence of cardiovascular disorders determined by electrocardiography, exercise testing, echocardiography, blood samples.


Enrollment:	803

Groups/Cohorts
HIV-infected Outpatients

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

● Acute cardiovascular disease or unstable hemodynamic status in the three weeks before inclusion

• Pregnancy

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01119729

Locations


Germany
Department of Dermatology, University Hospital of Bochum
Bochum, NRW, Germany, 44791
HIV Outpatient Department
Dortmund, NRW, Germany, 44137
HIV Outpatient Department
Duisburg, NRW, Germany, 47259
HIV Outpatients Department
Duisburg, NRW, Germany, 47055
Department of Dermatology, University Hospital of Essen
Essen, NRW, Germany, 45122
HIV Outpatient Department
Essen, NRW, Germany, 45127
West German Heart Center Essen
Essen, NRW, Germany, 45122

Sponsors and Collaborators

University Hospital, Essen

Federal Ministry of Education and Reserach (BMBF)

More Information

Publications:

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. Review. German.

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.

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.

Neumann T, Reinsch N, Neuhaus K, Brockmeyer N, Potthoff A, Esser S, Hower M, Neumann A, Mostardt S, Gelbrich G, Erbel R; für 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.

Neumann T, Esser S, Potthoff A, Pankuweit S, Neumann A, Breuckmann F, Neuhaus K, Kondratieva J, Buck T, Müller-Tasch T, Wachter R, Prettin C, Gelbrich G, Herzog W, Pieske B, Rauchhaus M, Löffler M, Maisch B, Mügge 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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.


Responsible Party:	PD Dr. med. Till Neumann, FESC, Competence Network of Heart Failure
ClinicalTrials.gov Identifier:	NCT01119729 History of Changes
Other Study ID Numbers:	FKZ 01GI0205
Study First Received:	May 7, 2010
Last Updated:	May 7, 2010
Health Authority:	Germany: Federal Ministry of Education and Reserach (BMBF) represented by the DLR Project Agency

Keywords provided by University Hospital, Essen:


Cardiac Diseases • HIV-Infection • AIDS • Antiretroviral Therapy

Additional relevant MeSH terms:


Cardiovascular Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Lentivirus Infections	RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Virus Diseases

ClinicalTrials.gov processed this record on February 27, 2015