Cardiovascular Diseases in HIV-infected Patients HIV-HEART Study: 7.5 Years Follow-up
HIV-HEART STUDY: A Prospective, Epidemiologic and Multicentre Trial to Determine the Cardiovascular Risk in HIV-infected Patients
1 other identifier
observational
1,481
1 country
6
Brief Summary
Since the introduction of antiretroviral therapy life expectancy of HIV-infected persons is rising. Different cohorts are observing an increased risk for cardiovascular diseases in this aging HIV-infected population. Traditional cardiovascular risk factors like smoking are more frequent in HIV-infected persons. For example chronic inflammation due to HIV-infection and metabolic disorders also caused by some antiretroviral substances as special non-traditional risk factors in HIV-infected persons can influence the development of cardiovascular diseases additionally. Therefore new research focus in special risk profile associated with HIV-infection or antiretroviral treatment and prevention for HIV-infected patients is developing. This present study is an ongoing prospective regional multicenter trial that was conducted to analyse the incidence, prevalence and clinical course of cardiovacular disorders in HIV-infected out-patients. Cardiac disorders witch are associated with HIV are pericarditis, pleural effusion, pulmonary hypertension, dilated cardiomyopathy, heart failure, myocarditis, bacterial endocarditis and 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2012
Typical duration for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 16, 2012
CompletedFirst Posted
Study publicly available on registry
August 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedOctober 28, 2014
October 1, 2014
2 years
August 16, 2012
October 27, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 7.5 follow-up to
Secondary Outcomes (1)
Cardiovascular Disorders in HIV-infected Patients HIV-HEART
Baseline up to 5 years follow-up
Study Arms (1)
Regional Ruhrgebiets Cohort
HIV-positive patients in the German Ruhr-Region from out-patient clinics of hospitals and HIV-physicians pratices
Interventions
* Anamnesis with the participian * File recherche,Physical examination * Documentation of the carciovascular and antiretroviral medical therapy * Electrocardiogram * Transthoracic echocardiography * Exercise electrocardiogram * Measuring of the arterial media thickness * Exercise Montreal Cognitive Assesment test * Exercise the Grooved Pegboard test * Blood collection * Questionnaire to quality of life and health economics
Eligibility Criteria
Participiants were included in several cities of the Ruhrarea. Locations were Essen, Bochum, Dortmund and Duisburg 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.
You may qualify if:
- Age \> 18 years
- Known HIV-infection
- Written informed consent
You may not qualify if:
- Acute cardiovascular disease
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Essenlead
- HIV-HEART Study Investigative Groupcollaborator
- German Heart Failure Networkcollaborator
- German Federal Ministry of Education and Researchcollaborator
- Bristol-Myers Squibbcollaborator
- ViiV Healthcarecollaborator
- Gilead Sciencescollaborator
- Janssen-Cilag GmbHcollaborator
- Abbottcollaborator
- Boehringer Ingelheimcollaborator
- Merck Sharp & Dohme LLCcollaborator
Study Sites (6)
University Hospital of Bochum, Department of Dermatology
Bochum, 44791, Germany
HIV Outpatient Department
Dortmund, 44137, Germany
Health Center
Duisburg, 47249, Germany
University Hospital, Department of Dermatology and Venerology
Essen, 45147, Germany
University Hospital, West German Heart Center Essen
Essen, 45147, Germany
Clinical Coordinating Center Leipzig
Leipzig, 04107, Germany
Related Publications (12)
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.
PMID: 18305915RESULTReinsch 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.
PMID: 18557952RESULTReinsch 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.
PMID: 19723613RESULTNeumann 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.
PMID: 20024643RESULTNeumann 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.
PMID: 17666313RESULTBreuckmann 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.
PMID: 16183552RESULTReinsch N, Kahlert P, Esser S, Sundermeyer A, Neuhaus K, Brockmeyer N, Potthoff A, Erbel R, Buck T, Neumann T. Echocardiographic findings and abnormalities in HIV-infected patients: results from a large, prospective, multicenter HIV-heart study. Am J Cardiovasc Dis. 2011;1(2):176-84. Epub 2011 Jul 30.
PMID: 22254197RESULTLind A, Reinsch N, Neuhaus K, Esser S, Brockmeyer NH, Potthoff A, Pankuweit S, Erbel R, Maisch B, Neumann T. Pericardial effusion of HIV-infected patients ? Results of a prospective multicenter cohort study in the era of antiretroviral therapy. Eur J Med Res. 2011 Nov 10;16(11):480-3. doi: 10.1186/2047-783x-16-11-480.
PMID: 22027640RESULTGelbrich B, Neumann T, Esser S, Potthoff A, Reinsch N, Hower M, Dannhauer KH, Loeffler M, Brockmeyer NH, Erbel R, Gelbrich G; HIV-HEART Study Investigative Group, Competence Networks Heart Failure and HIV/AIDS. Oral health and the heart - does HIV infection open a pathophysiological gateway? Int J Cardiol. 2011 Sep 1;151(2):254-7. doi: 10.1016/j.ijcard.2011.06.081. Epub 2011 Jul 18. No abstract available.
PMID: 21764468RESULTReinsch N, Neuhaus K, Esser S, Potthoff A, Hower M, Mostardt S, Neumann A, Brockmeyer NH, Gelbrich G, Erbel R, Neumann T; German Competence Network Heart Failure; German Competence Network for HIV/AIDS. Are HIV patients undertreated? Cardiovascular risk factors in HIV: results of the HIV-HEART study. Eur J Prev Cardiol. 2012 Apr;19(2):267-74. doi: 10.1177/1741826711398431. Epub 2011 Feb 28.
PMID: 21450595RESULTReinsch N, Neuhaus K, Esser S, Potthoff A, Hower M, Brockmeyer NH, Erbel R, Neumann T; German Competence Network for Heart Failure; German Competence Network for HIV AIDS. Prevalence of cardiac diastolic dysfunction in HIV-infected patients: results of the HIV-HEART study. HIV Clin Trials. 2010 May-Jun;11(3):156-62. doi: 10.1310/hct1103-156.
PMID: 20739268RESULTPotthoff A, Brockmeyer NH, Gelbrich G, Neuhaus K, Esser S, Reinsch N, Hower M, Mostardt S, Neumann A, Neumann T; Competence Center Cardiac Insufficiency and the Competence Network HIV/AIDS. Lipodystrophy - a sign for metabolic syndrome in patients of the HIV-HEART study. J Dtsch Dermatol Ges. 2010 Feb;8(2):92-8. doi: 10.1111/j.1610-0387.2009.07330.x. Epub 2009 Dec 14. English, German.
PMID: 20002869RESULT
Biospecimen
Stored blood samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stefan Esser, MD
University Hospital, Essen
- PRINCIPAL INVESTIGATOR
Till Neumann Neumann, MD
University Hospital, Essen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Academic Director
Study Record Dates
First Submitted
August 16, 2012
First Posted
August 17, 2012
Study Start
April 1, 2012
Primary Completion
April 1, 2014
Study Completion
October 1, 2014
Last Updated
October 28, 2014
Record last verified: 2014-10