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

NCT01196273 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1424

Last updated 2012-06-28

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • HIV-HEART Study Investigative Group

    collaborator UNKNOWN
  • German Heart Failure Network

    collaborator OTHER
  • German Competence Network for HIV/AIDS

    collaborator OTHER
  • German Federal Ministry of Education and Research

    collaborator OTHER_GOV
  • Bristol-Myers Squibb

    collaborator INDUSTRY
  • ViiV Healthcare

    collaborator INDUSTRY
  • GlaxoSmithKline

    collaborator INDUSTRY
  • Abbott

    collaborator INDUSTRY
  • Boehringer Ingelheim

    collaborator INDUSTRY
  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY
  • University Hospital, Essen

    lead OTHER

Principal Investigators

  • Stefan Esser, MD · University Hospital, Essen

  • Till Neumann, MD · University Hospital, Essen

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Germany

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01196273 on ClinicalTrials.gov