Cardiovascular Diseases in HIV-infected Patients HIV-HEART Study: 5 Years Follow-up
|ClinicalTrials.gov Identifier: NCT01196273|
Recruitment Status : Completed
First Posted : September 8, 2010
Last Update Posted : June 28, 2012
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
- Pleural effusion
- Pulmonary hypertension (Venedic classification typ II)
- Dilated cardiomyopathy
- Heart failure
- 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.
|Condition or disease||Intervention/treatment|
|Coronary Heart Disease Heart Failure HIV AIDS Metabolic Syndrome||Other: Comprehensive non invasive cardiovascular examination|
|Study Type :||Observational|
|Actual Enrollment :||1424 participants|
|Official Title:||HIV-HEART STUDY: A Prospective, Epidemiologic and Multicentre Trial to Determine the Cardiovascular Risk in HIV-infected Patients|
|Study Start Date :||December 2009|
|Primary Completion Date :||December 2011|
|Study Completion Date :||December 2011|
|Regional Ruhrgebiets Cohort||
Other: Comprehensive non invasive cardiovascular examination
The examination includes:
- Cardiovascular Diseases in HIV-infected Patients [ Time Frame: Baseline up to 5 years follow-up ]The detection of prevalence, aetiology, progression and severity of cardiovascular diseases - especially of coronary artery disease - in HIV-infected patients.
- Cardiovascular Disorders in HIV-infected Patients HIV-HEART [ Time Frame: Baseline up to 5 years follow-up ]The study also investigates the impact of established risk factors and new HIV-specific risk factors of coronary artery disease such as, age, gender, virus-load, CD4-cell count. The HIV-HEART study will focus on the impact of medication including cardiovascular medication and antiretroviral medication. Further secondary objectives will be examined, including economic costs and quality of life of subjects with and without cardiovascular diseases in this patient population.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01196273
|University Hospital of Bochum, Department of Dermatology|
|Bochum, Germany, 44791|
|HIV Outpatient Department|
|Dortmund, Germany, 44137|
|University Hospital, Department of Dermatology and Venerology|
|Essen, Germany, 45122|
|University Hospital, West German Heart Center Essen|
|Essen, Germany, 45122|
|Clinical Coordinating Center Leipzig|
|Leipzig, Germany, 04107|
|Principal Investigator:||Stefan Esser, MD||University Hospital, Essen|
|Principal Investigator:||Till Neumann, MD||University Hospital, Essen|