Cardiovascular Diseases in HIV-infected Patients HIV-HEART Study: 5 Years Follow-up
NCT ID: NCT01196273
Last Updated: 2012-06-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
1424 participants
OBSERVATIONAL
2009-12-31
2011-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Heart conditions that have been described with HIV include
* Pericarditis,
* Pleural effusion
* Pulmonary hypertension (Venedic classification typ II)
* Dilated cardiomyopathy
* Heart failure
* Myocarditis
* Bacterial endocarditis
* Heart valve disorders In addition to previously stated disorders of the heart, the premature atherosclerosis of coronary arteries, a further even more important disease of the heart in this patient population, went into the focus of most HIV-researchers and physicians.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Cardiovascular Diseases in HIV-infected Patients HIV-HEART Study: 7.5 Years Follow-up
NCT01667068
Cardiovascular Diseases in HIV-infected Subjects (HIV-HEART Study)
NCT01119729
HIV-Associated Heart Disease
NCT00005229
A Prospective Observational Trial to Determine Cardiovascular Diseases in HIV-infected Patients
NCT02291081
HIV-HEART Aging Study
NCT04330287
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Regional Ruhrgebiets Cohort
Comprehensive non invasive cardiovascular examination
The examination includes:
* Anamnesis incl. admission form
* Physical examination
* Documentation of the medical therapy (incl. HAART)
* Electrocardiogram
* Transthoracic echocardiography
* Exercise electrocardiogram
* 6 minute walk test
* Blood collection
* Questionnaire to quality of life and health economics
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Comprehensive non invasive cardiovascular examination
The examination includes:
* Anamnesis incl. admission form
* Physical examination
* Documentation of the medical therapy (incl. HAART)
* Electrocardiogram
* Transthoracic echocardiography
* Exercise electrocardiogram
* 6 minute walk test
* Blood collection
* Questionnaire to quality of life and health economics
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Known HIV-infection
* Written informed consent
Exclusion Criteria
* Unstable hemodynamic status in the three weeks before inclusion
* Pregnancy
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
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
OTHER_GOV
Bristol-Myers Squibb
INDUSTRY
ViiV Healthcare
INDUSTRY
GlaxoSmithKline
INDUSTRY
Abbott
INDUSTRY
Boehringer Ingelheim
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY
University Hospital, Essen
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
University Hospital
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Stefan Esser, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Essen
Till Neumann, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Essen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospital of Bochum, Department of Dermatology
Bochum, , Germany
HIV Outpatient Department
Dortmund, , Germany
University Hospital, Department of Dermatology and Venerology
Essen, , Germany
University Hospital, West German Heart Center Essen
Essen, , Germany
Clinical Coordinating Center Leipzig
Leipzig, , Germany
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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; 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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
09-4085
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.