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

NCT02291081 | Completed

• 1 other identifier: 12-4970-BO A
• Study Type: observational
• Target: 1,519
• Locations: 1 country
• Sites: 7

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.

Conditions

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

Keywords

HIV, AIDS; antiretroviral therapy; aging; heart failure; coronary heart disease; myocardial infarction; HIV-associated neurocognitive disorders

Outcome Measures

Primary Outcomes (1)

• Cardiovascular Diseases an deaths in HIV-infected Patients

  Baseline up to 10 year follow-up

Secondary Outcomes (1)

• Impact of classic cardiovascular risk factors and new HIV-specific risk factors of coronary artery disease, comorbidities and antiretroviral therapy

  Baseline up to 10 year follow-up

Interventions

Comprehensive non invasive cardiovascular examination OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age \> 18 years
• Known HIV-infection
• Written informed consent

You may not qualify if:

• Acute cardiovascular disease
• Pregnancy

Sponsors & Collaborators

• University Hospital, Essen: lead
• Nico Reinsch M. D.: collaborator
• Till Neumann Prof. M. D.: collaborator

Study Sites (7)

University Hospital of Bochum, Department of Dermatology

Bochum, North Rhine-Westphalia, 44791, Germany

Location

City Hospital Dortmund

Dortmund, North Rhine-Westphalia, 44137, Germany

Location

HIV physician pratice

Duisburg, North Rhine-Westphalia, 47259, Germany

Location

University Hospital, Department of Dermatology and Venerology

Essen, North Rhine-Westphalia, 45122, Germany

Location

HIV physician practice

Essen, North Rhine-Westphalia, 45136, Germany

Location

HIV physician practice

Krefeld, North Rhine-Westphalia, 47799, Germany

Location

Clinical Coordinating Center Leipzig

Leipzig, Saxony, 04107, Germany

Location

Related Publications (11)

• 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.

  PMID: 15257881 RESULT

• 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.

  PMID: 17513188 RESULT

• 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.

  PMID: 17666313 RESULT

• 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.

  PMID: 20002869 RESULT

• 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.

  PMID: 20024643 RESULT

• 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.

  PMID: 20739268 RESULT

• 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.

  PMID: 21450595 RESULT

• 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.

  PMID: 21764468 RESULT

• 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.

  PMID: 23117698 RESULT

• 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.

  PMID: 22027640 RESULT

• 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.

  PMID: 22254197 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Stored blood samples

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Coronary Disease; Myocardial Infarction; AIDS Dementia Complex; Heart Failure

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Stefan Esser, MD

  Depatment of dermatology and venerology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academic director

Study Record Dates

• First Submitted: October 21, 2014
• First Posted: November 14, 2014
• Study Start: October 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: January 1, 2017
• Last Updated: October 1, 2019

Record last verified: 2019-09

Locations

DE (7)