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| Name | Class |
|---|---|
| HIV-HEART Study Investigative Group | UNKNOWN |
| German Heart Failure Network | OTHER |
| German Competence Network for HIV/AIDS | OTHER |
| German Federal Ministry of Education and Research |
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HIV-infection is associated not only with a reduced function of the immune system, but also linked with diseases of other organ systems, in particular with the heart.
Heart conditions that have been described with HIV include
Premature atherosclerosis of coronary arteries results in coronary calcification, angina pectoris, myocardial infarction and sudden death. HIV-positive patients are at greater risk for a variety of heart-related conditions, including coronary artery disease. It is assumed, that HIV infection doubles the risk of a heart attack, according to recent research.
The reason for this link between HIV and heart-related conditions is unknown, but secondary infections that affect the heart muscle and coronary arteries have a greater chance of occurring in people with compromised immune systems. In addition, the HI-virus itself had been detected in the myocardium and might have an impact on the premature of cardiovascular diseases.
Furthermore, some of the medications used to treat HIV patients (antiretroviral therapy, ART) are assumed to have heart-related side effects.
Therefore, current treatment regimens for HIV infection have to be balanced against the marked benefits of antiretroviral treatment. Nevertheless, prevention of coronary heart disease should be integrated into current treatment procedures of HIV-infected patients.
The link between the heart and HIV is well established but not well understood. Therefore, further results are needed for efficient guidelines for the prevention, diagnostic and therapy of HIV-associated cardiovascular diseases.
A comprehensive detailed description of the study procedures had been previously published (European Journal of medical research 2007;12:243-248).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regional Ruhrgebiets Cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comprehensive non invasive cardiovascular examination | Other | The examination includes:
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular Diseases in HIV-infected Patients | The detection of prevalence, aetiology, progression and severity of cardiovascular diseases - especially of coronary artery disease - in HIV-infected patients. | Baseline up to 5 years follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular Disorders in HIV-infected Patients HIV-HEART | The study also investigates the impact of established risk factors and new HIV-specific risk factors of coronary artery disease such as, age, gender, virus-load, CD4-cell count. The HIV-HEART study will focus on the impact of medication including cardiovascular medication and antiretroviral medication. Further secondary objectives will be examined, including economic costs and quality of life of subjects with and without cardiovascular diseases in this patient population. |
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Inclusion Criteria:
Exclusion Criteria:
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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. Written informed consent was obtained from all participants.
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Esser, MD | University Hospital, Essen | Principal Investigator |
| Till Neumann, MD | University Hospital, Essen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Bochum, Department of Dermatology | Bochum | 44791 | Germany | |||
| HIV Outpatient Department |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18305915 | Result | 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. | |
| 18557952 | 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. |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006333 | Heart Failure |
| D000163 | Acquired Immunodeficiency Syndrome |
| D024821 | Metabolic Syndrome |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D015658 | HIV Infections |
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| ID | Term |
|---|---|
| D012149 | Restraint, Physical |
| D001800 | Blood Specimen Collection |
| D004472 | Health Care Economics and Organizations |
| ID | Term |
|---|---|
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
| D008919 | Investigative Techniques |
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| OTHER_GOV |
| Bristol-Myers Squibb | INDUSTRY |
| ViiV Healthcare | INDUSTRY |
| GlaxoSmithKline | INDUSTRY |
| Abbott | INDUSTRY |
| Boehringer Ingelheim | INDUSTRY |
| Merck Sharp & Dohme LLC | INDUSTRY |
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Stored blood samples
|
|
| Baseline up to 5 years follow-up |
| Dortmund |
| 44137 |
| Germany |
| University Hospital, Department of Dermatology and Venerology | Essen | 45122 | Germany |
| University Hospital, West German Heart Center Essen | Essen | 45122 | Germany |
| Clinical Coordinating Center Leipzig | Leipzig | 04107 | Germany |
| 19723613 | 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. |
| 20024643 | 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. |
| 17666313 | Result | 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. |
| 16183552 | Result | Breuckmann F, Neumann T, Kondratieva J, Wieneke H, Ross B, Nassenstein K, Barkhausen J, Kreuter A, Brockmeyer N, Erbel R. Dilated cardiomyopathy in two adult human immunodeficiency positive (HIV+) patients possibly related to highly active antiretroviral therapy (HAART). Eur J Med Res. 2005 Sep 12;10(9):395-9. |
| D000086982 |
| Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D013048 |
| Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |