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:

Genetics Home Reference related topics: complement factor I deficiency

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

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

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. 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.

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:

HIV Infections
Acquired Immunodeficiency Syndrome
Cardiovascular Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections

Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on March 03, 2013