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

Heart Failure Clinical Trial

— HIV-HEART10  

Official title:

A Prospective, Epidemiologic and Multicentre Trial to Determine the Cardiovascular Risk, New Cardiovascular Events and the Cardiovascular Diseases in HIV-infected Patients: 10 Year Follow-up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02291081
• Other study ID #: 12-4970-BO A
• Status: Completed
• Start date: October 2014
• Est. completion date: January 2017

Study information

• Verified date: September 2019
• Source: University Hospital, Essen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1519
• Est. completion date: January 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging
• AIDS Dementia Complex
• Brain Diseases
• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Heart Failure
• HIV-encephalopathy
• HIV-infection
• Infarction
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Other:
• 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

Locations

Country	Name	City	State
Germany	University Hospital of Bochum, Department of Dermatology	Bochum	NRW
Germany	City Hospital Dortmund	Dortmund	NRW
Germany	HIV physician pratice	Duisburg	NRW
Germany	HIV physician practice	Essen	NRW
Germany	University Hospital, Department of Dermatology and Venerology	Essen	NRW
Germany	HIV physician practice	Krefeld	NRW
Germany	Clinical Coordinating Center Leipzig	Leipzig	Sachsen

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Essen	Nico Reinsch M. D., Till Neumann Prof. M. D.

Country where clinical trial is conducted

Germany, 

References & Publications (11)

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 BN — View Citation

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. — View Citation

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 infecti — View Citation

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 — View Citation

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, Erbe — View Citation

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): — View Citation

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. 200 — View Citation

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 — View Citation

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 Card — View Citation

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 th — View Citation

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 f — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular Diseases an deaths in HIV-infected Patients		Baseline up to 10 year follow-up
Secondary	Impact of classic cardiovascular risk factors and new HIV-specific risk factors of coronary artery disease, comorbidities and antiretroviral therapy	Patients included in the pilot-baseline trial and additionally in the 5 and 7.5 year follow-up will be recruited again for the 10 year follow-up after giving informed consent. After including a total of 1481 patients in the previous phases, now both therapy-naive patients as well as patients being treated with new agents should be included.	Baseline up to 10 year follow-up