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

This study has been completed.
Sponsor:
Collaborators:
HIV-HEART Study Investigative Group
German Heart Failure Network
German Competence Network for HIV/AIDS
German Federal Ministry of Education and Research
Bristol Myers Squibb GmbH & Co.KGaA
ViiV Healthcare
GlaxoSmithKline
Abbott
Boehringer Ingelheim Pharma GmbH & Co. KG
Merck Sharp & Dohme Corp.
Information provided by:
University Hospital, Essen
ClinicalTrials.gov Identifier:
NCT01196273
First received: May 7, 2010
Last updated: June 27, 2012
Last verified: September 2010

May 7, 2010
June 27, 2012
December 2009
December 2011   (final data collection date for primary outcome measure)
Cardiovascular Diseases in HIV-infected Patients [ Time Frame: Baseline up to 5 years follow-up ] [ 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
Complete list of historical versions of study NCT01196273 on ClinicalTrials.gov Archive Site
Cardiovascular Disorders in HIV-infected Patients HIV-HEART [ Time Frame: Baseline up to 5 years follow-up ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Cardiovascular Diseases in HIV-infected Patients HIV-HEART Study: 5 Years Follow-up
HIV-HEART STUDY: A Prospective, Epidemiologic and Multicentre Trial to Determine the Cardiovascular Risk in HIV-infected Patients

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.

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
Retention:   Samples Without DNA
Description:

Stored blood samples

Non-Probability Sample

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

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
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.
 
Completed
1424
December 2011
December 2011   (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 information is only displayed when the study is recruiting subjects
Germany
 
NCT01196273
09-4085
Yes
PD Dr. med. Till Neumann MD, Dr. med. Stefan Esser MD, University Hospital
University Hospital, Essen
  • HIV-HEART Study Investigative Group
  • German Heart Failure Network
  • German Competence Network for HIV/AIDS
  • German Federal Ministry of Education and Research
  • Bristol Myers Squibb GmbH & Co.KGaA
  • ViiV Healthcare
  • GlaxoSmithKline
  • Abbott
  • Boehringer Ingelheim Pharma GmbH & Co. KG
  • Merck Sharp & Dohme Corp.
Principal Investigator: Stefan Esser, MD University Hospital, Essen
Principal Investigator: Till Neumann, MD University Hospital, Essen
University Hospital, Essen
September 2010

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