Clinical trial NCT01196273: Cardiovascular Diseases in HIV-infected Patients HIV-HEART Study: 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 Competence Network for HIV/AIDS
name: German Federal Ministry of Education and Research
name: Bristol-Myers Squibb
name: ViiV Healthcare
name: GlaxoSmithKline
name: Abbott
name: Boehringer Ingelheim
name: Merck Sharp & Dohme LLC
First posted: 2010-09-08
Enrollment: 1424
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: 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: 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

* 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.

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 5 years follow-up
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: 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, 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.