AIDS, Coronary Heart Disease, Heart Failure, HIV, Metabolic Syndrome
Conditions
Keywords
Cardiac Diseases, HIV-Infection, AIDS, Antiretroviral Therapy, Cardiovascular Medication, Risk Factors, coronary heart disease, heart failure, metabolic syndrome
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).
Interventions
* Anamnesis with the participian * File recherche,Physical examination * Documentation of the carciovascular and antiretroviral medical therapy * Electrocardiogram * Transthoracic echocardiography * Exercise electrocardiogram * Measuring of the arterial media thickness * Exercise Montreal Cognitive Assesment test * Exercise the Grooved Pegboard test * Blood collection * Questionnaire to quality of life and health economics
Sponsors
HIV-HEART Study Investigative Group
German Heart Failure Network
German Federal Ministry of Education and Research
Bristol-Myers Squibb
ViiV Healthcare
Gilead Sciences
Janssen-Cilag GmbH
Abbott
Boehringer Ingelheim
Merck Sharp & Dohme LLC
University Hospital, Essen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular Diseases in HIV-infected Patients | Baseline up to 7.5 follow-up to | The detection of prevalence, aetiology, progression and severity of cardiovascular diseases - especially of coronary artery disease in HIV-infected patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular Disorders in HIV-infected Patients HIV-HEART | Baseline up to 5 years follow-up | Complementary the study also investigates the impact of classic cardiovascular risk factors like gender, age, blood fat and also new HIV-specific risk factors of coronary artery disease like viral-load, CD4-cell count and stage of the infection. The HIV-HEART study will focus the impact of medication including cardiovascular and antiretroviral medication. Further secondary objectives will be examined, including economic costs and the subjectively quality of life of subjects with and without cardiovascular diseases in this patient population. |
Countries
Germany
Outcome results
None listed