Detection of Frequency, Severity and Progression of Cardiovascular Diseases in Patients With HIV-infection. Clinical Trial
| NCT number | NCT01119729 |
| Other study ID # | FKZ 01GI0205 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | May 7, 2010 |
| Last updated | May 7, 2010 |
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.
| Status | Completed |
| Enrollment | 803 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Germany | Department of Dermatology, University Hospital of Bochum | Bochum | NRW |
| Germany | HIV Outpatient Department | Dortmund | NRW |
| Germany | HIV Outpatient Department | Duisburg | NRW |
| Germany | HIV Outpatients Department | Duisburg | NRW |
| Germany | Department of Dermatology, University Hospital of Essen | Essen | NRW |
| Germany | HIV Outpatient Department | Essen | NRW |
| Germany | West German Heart Center Essen | Essen | NRW |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Essen | Federal Ministry of Education and Reserach (BMBF) |
Germany,
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. — View Citation
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): — View Citation
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. — View Citation
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 — View Citation
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;1 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Prevalence of cardiovascular diseases | Prevalence of cardiovascular diseases including coronary artery disease, congestive heart failure, peripheral arterial disease, cerebrovascular events, and valvular diseases. | ||
| Secondary | Prevalence of cardiovascular disorders | Prevalence of cardiovascular disorders determined by electrocardiography, exercise testing, echocardiography, blood samples. |