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

Purpose

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	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:

MedlinePlus related topics: HIV/AIDS Heart Diseases Heart Failure Metabolic Syndrome

Genetic and Rare Diseases Information Center resources: Abdominal Obesity Metabolic Syndrome

U.S. FDA Resources

Further study details as provided by University Hospital, Essen:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.

Biospecimen Retention: Samples With DNA

Stored blood samples


Enrollment:	1481
Study Start Date:	April 2012
Study Completion Date:	October 2014
Primary Completion Date:	April 2014 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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

Groups/Cohorts

Assigned Interventions

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

Detailed Description:

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

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01667068

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 GmbH & Co. KG

ViiV Healthcare

Gilead Sciences GmbH

Janssen-Cilag GmbH

Abbott

Boehringer Ingelheim Pharma GmbH & Co. KG

MSD Sharp & Dohmen GmbH

Investigators


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

More Information

Additional Information:

Internet presentation of current Study This link exits the ClinicalTrials.gov site

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.

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
Study First Received:	August 16, 2012
Last Updated:	October 27, 2014
Health Authority:	Germany: Federal Ministry of Education and Research

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:


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

ClinicalTrials.gov processed this record on March 01, 2015