Clinical trial NCT01667068: Cardiovascular Diseases in HIV-infected Patients HIV-HEART Study: 7.5 Years Follow-up
Official title: HIV-HEART STUDY: A Prospective, Epidemiologic and Multicentre Trial to Determine the Cardiovascular Risk in HIV-infected Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Heart Disease
Heart Failure
HIV
AIDS
Metabolic Syndrome
Keywords: Cardiac Diseases
HIV-Infection
AIDS
Antiretroviral Therapy
Cardiovascular Medication
Risk Factors
coronary heart disease
heart failure
metabolic syndrome
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
Collaborators: name: HIV-HEART Study Investigative Group
name: German Heart Failure Network
name: German Federal Ministry of Education and Research
name: Bristol-Myers Squibb
name: ViiV Healthcare
name: Gilead Sciences
name: Janssen-Cilag GmbH
name: Abbott
name: Boehringer Ingelheim
name: Merck Sharp & Dohme LLC
First posted: 2012-08-17
Enrollment: 1481
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Detailed description: A comprehensive detailed description of the study procedures had been previously published (European Journal of medical research 2007;12:243-248).

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Known HIV-infection
* Written informed consent

Exclusion Criteria:

* Acute cardiovascular disease
* Unstable hemodynamic status in the three weeks before inclusion
* Pregnancy

Primary outcomes:
measure: Cardiovascular Diseases in HIV-infected Patients
timeFrame: Baseline up to 7.5 follow-up to
Secondary outcomes:
measure: Cardiovascular Disorders in HIV-infected Patients HIV-HEART
timeFrame: Baseline up to 5 years follow-up
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: University Hospital of Bochum, Department of Dermatology
city: Dortmund
country: Germany
facility: HIV Outpatient Department
city: Duisburg
country: Germany
facility: Health Center
city: Essen
country: Germany
facility: University Hospital, Department of Dermatology and Venerology
city: Essen
country: Germany
facility: University Hospital, West German Heart Center Essen
city: Leipzig
country: Germany
facility: Clinical Coordinating Center Leipzig
Study officials:
affiliation: University Hospital, Essen
name: Stefan Esser, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Essen
name: Till Neumann Neumann, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. German.
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. HIV Med. 2008 Aug;9(7):550-6. doi: 10.1111/j.1468-1293.2008.00602.x. Epub 2008 Jun 28.
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;10(4):261-8. doi: 10.1310/hct1004-261.
citation: 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.
citation: 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.
citation: 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.
citation: Reinsch 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.
citation: Lind 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.
citation: Gelbrich 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.
citation: Reinsch 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.
citation: Reinsch 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.
citation: Potthoff 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.