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

This study has been completed.

Sponsor:

Collaborator:

Federal Ministry of Education and Reserach (BMBF)

Information provided by:

University Hospital, Essen

ClinicalTrials.gov Identifier:

NCT01119729

First received: May 7, 2010

Last updated: NA

Last verified: May 2010

History: No changes posted

Tracking Information
First Received Date ^ICMJE	May 7, 2010
Last Updated Date	May 7, 2010
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: May 7, 2010)	Prevalence of cardiovascular diseases Prevalence of cardiovascular diseases including coronary artery disease, congestive heart failure, peripheral arterial disease, cerebrovascular events, and valvular diseases.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: May 7, 2010)	Prevalence of cardiovascular disorders Prevalence of cardiovascular disorders determined by electrocardiography, exercise testing, echocardiography, blood samples.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Cardiovascular Diseases in HIV-infected Subjects (HIV-HEART Study)
Official Title ^ICMJE	Not Provided
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
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
Condition ^ICMJE	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
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	HIV-infected Outpatients
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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	803
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Not Provided
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT01119729
Other Study ID Numbers ^ICMJE	FKZ 01GI0205
Has Data Monitoring Committee	Yes
Responsible Party	PD Dr. med. Till Neumann, FESC, Competence Network of Heart Failure
Study Sponsor ^ICMJE	University Hospital, Essen
Collaborators ^ICMJE	Federal Ministry of Education and Reserach (BMBF)
Investigators ^ICMJE	Not Provided
Information Provided By	University Hospital, Essen
Verification Date	May 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top