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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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.

Condition or disease	Intervention/treatment
Coronary Heart Disease; Heart Failure; HIV; AIDS; Metabolic Syndrome	Other: Comprehensive non invasive cardiovascular examination

Detailed Description:

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

Study Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational
Actual Enrollment :	1481 participants
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
Study Start Date :	April 2012
Actual Primary Completion Date :	April 2014
Actual Study Completion Date :	October 2014

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort

Intervention/treatment

Regional Ruhrgebiets Cohort; HIV-positive patients in the German Ruhr-Region from out-patient clinics of hospitals and HIV-physicians pratices

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

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

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 Outcome Measures :

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.

Biospecimen Retention:   Samples With DNA

Stored blood samples

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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.

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Germany
University Hospital of Bochum, Department of Dermatology
Bochum, Germany, 44791
HIV Outpatient Department
Dortmund, Germany, 44137
Health Center
Duisburg, Germany, 47249
University Hospital, Department of Dermatology and Venerology
Essen, Germany, 45147
University Hospital, West German Heart Center Essen
Essen, Germany, 45147
Clinical Coordinating Center Leipzig
Leipzig, Germany, 04107

Sponsors and Collaborators

University Hospital, Essen

HIV-HEART Study Investigative Group

German Heart Failure Network

German Federal Ministry of Education and Research

Bristol-Myers Squibb

ViiV Healthcare

Gilead Sciences GmbH

Janssen-Cilag GmbH

Abbott

Boehringer Ingelheim

MSD Sharp & Dohmen GmbH

Investigators

Principal Investigator:	Stefan Esser, MD	University Hospital, Essen
Principal Investigator:	Till Neumann Neumann, MD	University Hospital, Essen

More Information

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Publications of Results:

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.

Reinsch N, Kahlert P, Esser S, Sundermeyer A, Neuhaus K, Brockmeyer N, Potthoff A, Erbel R, Buck T, Neumann T. Echocardiographic findings and abnormalities in HIV-infected patients: results from a large, prospective, multicenter HIV-heart study. Am J Cardiovasc Dis. 2011;1(2):176-84. Epub 2011 Jul 30.

Lind A, Reinsch N, Neuhaus K, Esser S, Brockmeyer NH, Potthoff A, Pankuweit S, Erbel R, Maisch B, Neumann T. Pericardial effusion of HIV-infected patients ? Results of a prospective multicenter cohort study in the era of antiretroviral therapy. Eur J Med Res. 2011 Nov 10;16(11):480-3.

Gelbrich B, Neumann T, Esser S, Potthoff A, Reinsch N, Hower M, Dannhauer KH, Loeffler M, Brockmeyer NH, Erbel R, Gelbrich G; HIV-HEART Study Investigative Group, Competence Networks Heart Failure and HIV/AIDS. Oral health and the heart - does HIV infection open a pathophysiological gateway? Int J Cardiol. 2011 Sep 1;151(2):254-7. doi: 10.1016/j.ijcard.2011.06.081. Epub 2011 Jul 18.

Reinsch N, Neuhaus K, Esser S, Potthoff A, Hower M, Mostardt S, Neumann A, Brockmeyer NH, Gelbrich G, Erbel R, Neumann T; German Competence Network Heart Failure; German Competence Network for HIV/AIDS. Are HIV patients undertreated? Cardiovascular risk factors in HIV: results of the HIV-HEART study. Eur J Prev Cardiol. 2012 Apr;19(2):267-74. doi: 10.1177/1741826711398431. Epub 2011 Feb 28.

Reinsch N, Neuhaus K, Esser S, Potthoff A, Hower M, Brockmeyer NH, Erbel R, Neumann T; German Competence Network for Heart Failure; German Competence Network for HIV AIDS. Prevalence of cardiac diastolic dysfunction in HIV-infected patients: results of the HIV-HEART study. HIV Clin Trials. 2010 May-Jun;11(3):156-62. doi: 10.1310/hct1103-156.

Potthoff A, Brockmeyer NH, Gelbrich G, Neuhaus K, Esser S, Reinsch N, Hower M, Mostardt S, Neumann A, Neumann T; Competence Center Cardiac Insufficiency and the Competence Network HIV/AIDS. Lipodystrophy - a sign for metabolic syndrome in patients of the HIV-HEART study. J Dtsch Dermatol Ges. 2010 Feb;8(2):92-8. doi: 10.1111/j.1610-0387.2009.07330.x. Epub 2009 Dec 14. English, German.

Responsible Party:	Stefan Esser M.D., Academic Director, University Hospital, Essen
ClinicalTrials.gov Identifier:	NCT01667068 History of Changes
Other Study ID Numbers:	12-4970-BO
First Posted:	August 17, 2012
Last Update Posted:	October 28, 2014
Last Verified:	October 2014

Keywords provided by Stefan Esser M.D., 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