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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01196273
First Posted: September 8, 2010
Last Update Posted: June 28, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
ViiV Healthcare
GlaxoSmithKline
Abbott
Boehringer Ingelheim
Merck Sharp & Dohme Corp.
Information provided by:
University Hospital, Essen
  Purpose

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.


Condition Intervention
Coronary Heart Disease Heart Failure HIV AIDS Metabolic Syndrome Other: Comprehensive non invasive cardiovascular examination

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: HIV-HEART STUDY: A Prospective, Epidemiologic and Multicentre Trial to Determine the Cardiovascular Risk in HIV-infected Patients

Resource links provided by NLM:


Further study details as provided by University Hospital, Essen:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.


Biospecimen Retention:   Samples Without DNA
Stored blood samples

Enrollment: 1424
Study Start Date: December 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Regional Ruhrgebiets Cohort 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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01196273


Locations
Germany
University Hospital of Bochum, Department of Dermatology
Bochum, Germany, 44791
HIV Outpatient Department
Dortmund, Germany, 44137
University Hospital, Department of Dermatology and Venerology
Essen, Germany, 45122
University Hospital, West German Heart Center Essen
Essen, Germany, 45122
Clinical Coordinating Center Leipzig
Leipzig, Germany, 04107
Sponsors and Collaborators
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
ViiV Healthcare
GlaxoSmithKline
Abbott
Boehringer Ingelheim
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Stefan Esser, MD University Hospital, Essen
Principal Investigator: Till Neumann, MD University Hospital, Essen
  More Information

Publications:
Neumann T. [HIV, AIDS and the cardiovascular risk]. Internist (Berl). 2008 Apr;49(4):429-30, 432-5. doi: 10.1007/s00108-008-2049-4. Review. German.
Reinsch N, Buhr C, Krings P, Kaelsch H, Kahlert P, Konorza T, Neumann T, Erbel R; Competence Network of Heart Failure. Effect of gender and highly active antiretroviral therapy on HIV-related pulmonary arterial hypertension: results of the HIV-HEART Study. HIV Med. 2008 Aug;9(7):550-6. doi: 10.1111/j.1468-1293.2008.00602.x. Epub 2008 Jun 28.
Reinsch N, Buhr C, Krings P, Kaelsch H, Neuhaus K, Wieneke H, Erbel R, Neumann T; German Heart Failure Network. Prevalence and risk factors of prolonged QTc interval in HIV-infected patients: results of the HIV-HEART study. HIV Clin Trials. 2009 Jul-Aug;10(4):261-8. doi: 10.1310/hct1004-261.
Neumann T, Reinsch N, Neuhaus K, Brockmeyer N, Potthoff A, Esser S, Hower M, Neumann A, Mostardt S, Gelbrich G, Erbel R; für die HIV-HEART-Studie sowie die Kompetenznetze Herzinsuffizienz und HIV/AIDS. [BNP in HIV-infected patients]. Herz. 2009 Dec;34(8):634-40. doi: 10.1007/s00059-009-3313-7. German.
Neumann T, Esser S, Potthoff A, Pankuweit S, Neumann A, Breuckmann F, Neuhaus K, Kondratieva J, Buck T, Müller-Tasch T, Wachter R, Prettin C, Gelbrich G, Herzog W, Pieske B, Rauchhaus M, Löffler M, Maisch B, Mügge A, Wasem J, Gerken G, Brockmeyer NH, Erbel R; HIV-HEART Study Investigative Group. Prevalence and natural history of heart failure in outpatient HIV-infected subjects: rationale and design of the HIV-HEART study. Eur J Med Res. 2007 Jun 27;12(6):243-8.
Breuckmann F, Neumann T, Kondratieva J, Wieneke H, Ross B, Nassenstein K, Barkhausen J, Kreuter A, Brockmeyer N, Erbel R. Dilated cardiomyopathy in two adult human immunodeficiency positive (HIV+) patients possibly related to highly active antiretroviral therapy (HAART). Eur J Med Res. 2005 Sep 12;10(9):395-9.

Responsible Party: PD Dr. med. Till Neumann MD, Dr. med. Stefan Esser MD, University Hospital
ClinicalTrials.gov Identifier: NCT01196273     History of Changes
Other Study ID Numbers: 09-4085
First Submitted: May 7, 2010
First Posted: September 8, 2010
Last Update Posted: June 28, 2012
Last Verified: September 2010

Keywords provided by University Hospital, Essen:
Cardiac Diseases,
HIV-Infection,
AIDS,
Antiretroviral Therapy,
Cardiovascular Medication,
Risk Factors,
coronary heart disease,
heart failure,
metabolic syndrome

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Metabolic Syndrome X
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases


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