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

NCT01667068 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1481

Last updated 2014-10-28

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Comprehensive non invasive cardiovascular examination

* 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 & Collaborators

  • HIV-HEART Study Investigative Group

    collaborator UNKNOWN
  • German Heart Failure Network

    collaborator OTHER
  • German Federal Ministry of Education and Research

    collaborator OTHER_GOV
  • Bristol-Myers Squibb

    collaborator INDUSTRY
  • ViiV Healthcare

    collaborator INDUSTRY
  • Gilead Sciences

    collaborator INDUSTRY
  • Janssen-Cilag GmbH

    collaborator UNKNOWN
  • 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 Neumann, MD · University Hospital, Essen

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2014-04-30
Completion
2014-10-31

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 NCT01667068 on ClinicalTrials.gov