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NCT Number: NCT01196273

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

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comprehensive non invasive cardiovascular examination

Other

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

Other names: 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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Essen

Other

Collaborators

  • Abbott
  • Boehringer Ingelheim
  • Bristol-Myers Squibb
  • German Competence Network for HIV/AIDS
  • German Federal Ministry of Education and Research
  • German Heart Failure Network
  • GlaxoSmithKline
  • HIV-HEART Study Investigative Group
  • Merck Sharp & Dohme LLC
  • ViiV Healthcare

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 8, 2010
Registry last updated
Jun 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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