NCT01196273

Cardiovascular Diseases in HIV-infected Patients HIV-HEART Study: 5 Years Follow-up

HIV-HEART STUDY: A Prospective, Epidemiologic and Multicentre Trial to Determine the Cardiovascular Risk in HIV-infected Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,424 (actual)
• Sponsor: University Hospital, Essen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Coronary Heart Disease
• Heart Failure
• HIV
• AIDS
• Metabolic Syndrome

Interventions

Type	Name	Description
OTHER	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

Timeline

• Start date: 2009-12-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2010-09-08
• Last updated: 2012-06-28

Locations

5 sites across 1 country: Germany