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Completed

NCT Number: NCT01667068

Cardiovascular Diseases in HIV-infected Patients HIV-HEART Study: 7.5 Years Follow-up

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.

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Key information

Conditions

Coronary Heart Disease AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Cardiovascular Diseases Communicable Diseases Coronary Disease Genital Diseases Glucose Metabolism Disorders HIV HIV Infections Heart Diseases Heart Failure Hyperinsulinism Immune System Diseases Immunologic Deficiency Syndromes Infections Insulin Resistance Lentivirus Infections Metabolic Diseases Metabolic Syndrome Myocardial Ischemia Nutritional and Metabolic Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Vascular Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Bochum, Department of Dermatology, Bochum, Germany

Loading trial locations.

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
  • 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

Primary outcomes

  1. Cardiovascular Diseases in HIV-infected Patients

    Time frame: 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 outcomes

  1. Cardiovascular Disorders in HIV-infected Patients HIV-HEART

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Essen

Other

Collaborators

  • Abbott
  • Boehringer Ingelheim
  • Bristol-Myers Squibb
  • German Federal Ministry of Education and Research
  • German Heart Failure Network
  • Gilead Sciences
  • HIV-HEART Study Investigative Group
  • Janssen-Cilag Ltd.
  • 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
2012
Primary completion
2014
Study completion
2014
First posted
Aug 17, 2012
Registry last updated
Oct 28, 2014

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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