HIV-HEART Aging Study

HIV Infections Clinical Trial

— HIVH  

Official title:

A Prospective, Epidemiologic and Multicentre Trial to Determine the Cardiovascular Risk, New Cardiovascular Events and the Cardiovascular Diseases in HIV-infected Patients: 15 Year Follow up

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04330287
• Other study ID #: 14-5874-BO
• Status: Recruiting
• Start date: May 11, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2023
• Source: University Hospital, Essen
• Contact: Stefan Esser, PD MD
• Phone: 00492017233878
• Email: stefan.esser[@]uk-essen.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The HIV/HEART Aging 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 October 2022 (15 year Follow-up) 1858 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 (optional)

• Exercise electrocardiogram (optional)

• Exercise Montreal Cognitive Assessment test (optional)

• Exercise the Grooved Pegboard test (optional)

• Blood and stool sample collection (optional)

• Questionnaire to quality of life and health economics

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2025
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years

• Known HIV-infection

• Signed 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
• Coronary Disease
• Heart Failure
• HIV Encephalopathy
• HIV Infections
• Infarction
• Myocardial Infarction
• Weight Gain

Locations

Country	Name	City	State
Germany	University Hospital of Bochum, Department of Dermatology	Bochum
Germany	HIV Outpatient Department	Dortmund
Germany	HIV physician pratice	Duisburg	NRW
Germany	Institut für Medizinische Informatik, Biometrie und Epidemiologie	Essen	Nordrhein-Westfalen
Germany	Universitätsklinikum Essen, Klinik für Dermatologie	Essen	Nordrheinwestfalen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Essen

Country where clinical trial is conducted

Germany, 

References & Publications (4)

Kehrmann J, Menzel J, Saeedghalati M, Obeid R, Schulze C, Holzendorf V, Farahpour F, Reinsch N, Klein-Hitpass L, Streeck H, Hoffmann D, Buer J, Esser S; HIV-HEART Study Group. Gut Microbiota in Human Immunodeficiency Virus-Infected Individuals Linked to C — View Citation

Mavarani L, Albayrak-Rena S, Potthoff A, Hower M, Dolff S, Sammet S, Maischack F, Schadendorf D, Schmidt B, Esser S; HIV HEART AGING Study. Changes in body mass index, weight, and waist-to-hip ratio over five years in HIV-positive individuals in the HIV H — View Citation

Reinsch N, Streeck H, Holzendorf V, Schulze C, Neumann T, Brockmeyer NH, Kehrmann J, Schadendorf D, Esser S; HIV HEART Study Group. B-type natriuretic peptides for the prediction of cardiovascular events and mortality in patients living with HIV: Results — View Citation

Schulz CA, Mavarani L, Reinsch N, Albayrak-Rena S, Potthoff A, Brockmeyer N, Hower M, Erbel R, Jockel KH, Schmidt B, Esser S; HIV HEART Aging Study Group and Heinz Nixdorf Recall Investigative Group. Prediction of future cardiovascular events by Framingha — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of frequency, severity of cardiovascular diseases - especially of coronary artery disease - in patients with HIV-Infection	Calculation of the Framingham Risk Score. It was assumed, that in the next 10 years the individual cardiovascular risk varies between maximal 20% and minimal 0%.	Baseline up to 15 year follow up
Primary	Detection of progression of cardiovascular diseases - especially of coronary artery disease - in patients with HIV-Infection	Calculation of Odds Ratio	Baseline up to 15 year follow up
Secondary	Impact on cardiovascular risk on amount of atherosclerosis	in relation to age, gender and classic cardiovascular rsik factors inter alia smoking, diabetes, hypercholesterinaemia and arterial hypertension by calculating the relative risk	Baseline up to 15 year follow up
Secondary	Impact on life quality	in relation to HIV-specfic cardiovascular rsik factors including inter alia virus load (copies/ml) in combination with CD4-count and duration of HV-Infection by calculating the standard deviation	Baseline up to 15 year follow up
Secondary	Impact on life quality	in relation to HIV-specfic cardiovascular rsik factors including inter alia CD4-count (cells/mm3) in combination with virus load and duration of HIV-infection by calculating the standard deviation	Baseline up to 15 year follow up
Secondary	Impact on life quality	in relation to HIV-specfic cardiovascular rsik factors including inter alia duration of HIV-Infection (in years) in combination with virus load and CD4-count by calculating the standard deviation	Baseline up to 15 year follow up
Secondary	Impact on cardiovascular risk, amount of atherosclerosis and life quality	in relation to cardiovascular and antiretroviral medication by calculating the 95%-Confidence interval	Baseline up to 15 year follow up