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

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

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

Conditions
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Coronary Heart Disease, Heart Failure, HIV, AIDS, Metabolic Syndrome

Intervention / Treatment
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* Other: Comprehensive non invasive cardiovascular examination


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Regional Ruhrgebiets Cohort<br> | Other: Comprehensive non invasive cardiovascular examination<br>* 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<br>* Other names: Questionnaire to quality of life and health economics;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 5 years follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular Disorders in HIV-infected Patients HIV-HEART | 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. | Baseline up to 5 years follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Diseases,, HIV-Infection,, AIDS,, Antiretroviral Therapy,, Cardiovascular Medication,, Risk Factors,, coronary heart disease,, heart failure,, metabolic syndrome