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

This study is currently recruiting participants.
Verified April 2012 by University Hospital, Essen
Sponsor:
Collaborators:
HIV-HEART Study Investigative Group
German Heart Failure Network
German Federal Ministry of Education and Research
Bristol-Myers Squibb GmbH & Co. KG
ViiV Healthcare
Gilead Sciences GmbH
Janssen-Cilag GmbH
Abbott
Boehringer Ingelheim Pharma GmbH & Co. KG
MSD Sharp & Dohmen GmbH
Information provided by:
University Hospital, Essen
ClinicalTrials.gov Identifier:
NCT01667068
First received: August 16, 2012
Last updated: NA
Last verified: April 2012
History: No changes posted

August 16, 2012
August 16, 2012
April 2012
May 2014   (final data collection date for primary outcome measure)
Cardiovascular Diseases in HIV-infected Patients [ Time Frame: Baseline up to 7.5 follow-up to ] [ Designated as safety issue: No ]
The detection of prevalence, aetiology, progression and severity of cardiovascular diseases - especially of coronary artery disease in HIV-infected patients.
Same as current
No Changes Posted
Cardiovascular Disorders in HIV-infected Patients HIV-HEART [ Time Frame: Baseline up to 5 years follow-up ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Cardiovascular Diseases in HIV-infected Patients HIV-HEART Study: 7.5 Years Follow-up
HIV-HEART STUDY: A Prospective, Epidemiologic and Multicentre Trial to Determine the Cardiovascular Risk in HIV-infected Patients

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.

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided

Stored blood samples

Non-Probability Sample

Participiants were included in several cities of the Ruhrarea. Locations were Essen, Bochum, Dortmund and Duisburg The study population included outpatients who were at least 18 years of age, had a known HIV-infection and exhibited a stable disease status within 4 weeks before inclusion of the trial. Written informed consent was obtained from all participants.

  • Coronary Heart Disease
  • Heart Failure
  • HIV
  • AIDS
  • Metabolic Syndrome
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
Regional Ruhrgebiets Cohort
Intervention: Other: Comprehensive non invasive cardiovascular examination

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1450
October 2014
May 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Stefan Esser, MD ++49 201 723 3878 stefan.esser@uk-essen.de
Contact: Till Neumann, MD ++49 201 723 4806 till.neumann@uk-essen.de
Germany
 
NCT01667068
12-4970-BO
Yes
Not Provided
University Hospital, Essen
  • HIV-HEART Study Investigative Group
  • German Heart Failure Network
  • German Federal Ministry of Education and Research
  • Bristol-Myers Squibb GmbH & Co. KG
  • ViiV Healthcare
  • Gilead Sciences GmbH
  • Janssen-Cilag GmbH
  • Abbott
  • Boehringer Ingelheim Pharma GmbH & Co. KG
  • MSD Sharp & Dohmen GmbH
Principal Investigator: Stefan Esser, MD University Hospital, Essen
Principal Investigator: Till Neumann Neumann, MD University Hospital, Essen
University Hospital, Essen
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP