A Prospective Observational Trial to Determine Cardiovascular Diseases in HIV-infected Patients

NCT ID: NCT02291081

Last Updated: 2019-10-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1519 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2017-01-31

Brief Summary

The HIV/HEART study (HIVH) is an ongoing, prospective, multicentre trial that was conducted to assess the incidence, the prevalence and the clinical course of cardiovascular diseases (CVD) in HIV-infected patients. The study population includes outpatients from specialized HIV-care units of the German Ruhr region, who were at least 18 years of age, were known to have a HIV-infection and exhibited a stable disease status within 4 weeks before inclusion into the trial. From March 2004 (Pilot phase) to May 2014 (7,5 year Follow-up) 1481 HIV+ patients were recruited in a consecutive manner. The standardised examinations included a targeted assessment of medical history and physical examination. Blood was drawn for comprehensive laboratory tests including HIV specific parameters (CD4 cell count, HIV-1 RNA levels) and cardiovascular items (lipid concentrations, BNP values and renal parameters). Furthermore, non-invasive tests were performed during the initial visit, including additional heart rate and blood pressure measurements, electrocardiogram (ECGs) and transthoracic echocardiography (TTE). Examinations were completed in accordance with previously defined standard operating procedures. CVD were defined as coronary, cerebrovascular, peripheral arterial disease, heart failure or cardiac vitium.

Detailed Description

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

Comprehensive non invasive cardiovascular examination

• Anamnesis
• File recherche,Physical examination
• Documentation of the cardiovascular and antiretroviral medical therapy
• Electrocardiogram
• Transthoracic echocardiography
• Exercise electrocardiogram
• Exercise Montreal Cognitive Assessment test
• Exercise the Grooved Pegboard test
• Blood collection
• Questionnaire to quality of life and health economics

Conditions

HIV-infection; Coronary Heart Disease; Myocardial Infarction; HIV-encephalopathy; Heart Failure; Aging

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Comprehensive non invasive cardiovascular examination

Comprehensive non invasive cardiovascular examination

• Anamnesis with the participants
• File recherche,Physical examination
• Documentation of the cardiovascular and antiretroviral medical therapy
• Electrocardiogram
• Transthoracic echocardiography
• Exercise electrocardiogram
• Exercise Montreal Cognitive Assessment test
• Exercise the Grooved Pegboard test
• Blood collection
• Questionnaire to quality of life and health economics

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nico Reinsch M. D.

UNKNOWN

Sponsor Role: collaborator

Till Neumann Prof. M. D.

UNKNOWN

Sponsor Role: collaborator

University Hospital, Essen

OTHER

Sponsor Role: lead

Responsible Party

Stefan Esser M.D.

Academic director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefan Esser, MD

Role: PRINCIPAL_INVESTIGATOR

Depatment of dermatology and venerology

Locations

University Hospital of Bochum, Department of Dermatology

Bochum, North Rhine-Westphalia, Germany

City Hospital Dortmund

Dortmund, North Rhine-Westphalia, Germany

HIV physician pratice

Duisburg, North Rhine-Westphalia, Germany

University Hospital, Department of Dermatology and Venerology

Essen, North Rhine-Westphalia, Germany

HIV physician practice

Essen, North Rhine-Westphalia, Germany

HIV physician practice

Krefeld, North Rhine-Westphalia, Germany

Clinical Coordinating Center Leipzig

Leipzig, Saxony, Germany

Countries

Germany

References

Neumann T, Woiwod T, Neumann A, Miller M, Von Birgelen C, Volbracht L, Esser S, Brockmeyer N, Gerken G, Erbel R. Cardiovascular risk factors and probability for cardiovascular events in HIV-infected patients - part III: age differences. Eur J Med Res. 2004 May 28;9(5):267-72.

Reference Type: RESULT

PMID: 15257881 (View on PubMed)

Breuckmann F, Nassenstein K, Kondratieva J, Esser S, Erbel R, Potthoff A, Brockmeyer NH, Neumann T, Barkhausen J; German Heart Failure Network; Competence Network HIV/AIDS. MR characterization of cardiac abnormalities in HIV+ individuals with increased BNP levels. Eur J Med Res. 2007 May 29;12(5):185-90.

Reference Type: RESULT

PMID: 17513188 (View on PubMed)

Neumann T, Esser S, Potthoff A, Pankuweit S, Neumann A, Breuckmann F, Neuhaus K, Kondratieva J, Buck T, Muller-Tasch T, Wachter R, Prettin C, Gelbrich G, Herzog W, Pieske B, Rauchhaus M, Loffler M, Maisch B, Mugge 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.

Reference Type: RESULT

PMID: 17666313 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20002869 (View on PubMed)

Neumann T, Reinsch N, Neuhaus K, Brockmeyer N, Potthoff A, Esser S, Hower M, Neumann A, Mostardt S, Gelbrich G, Erbel R; fur 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.

Reference Type: RESULT

PMID: 20024643 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20739268 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21450595 (View on PubMed)

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. No abstract available.

Reference Type: RESULT

PMID: 21764468 (View on PubMed)

Esser S, Gelbrich G, Brockmeyer N, Goehler A, Schadendorf D, Erbel R, Neumann T, Reinsch N. Prevalence of cardiovascular diseases in HIV-infected outpatients: results from a prospective, multicenter cohort study. Clin Res Cardiol. 2013 Mar;102(3):203-13. doi: 10.1007/s00392-012-0519-0. Epub 2012 Nov 2.

Reference Type: RESULT

PMID: 23117698 (View on PubMed)

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. doi: 10.1186/2047-783x-16-11-480.

Reference Type: RESULT

PMID: 22027640 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22254197 (View on PubMed)

Other Identifiers

12-4970-BO A

Identifier Type: -

Identifier Source: org_study_id