Gut Microbiota in Human Immunodeficiency Virus-Infected Individuals Linked to Coronary Heart Disease.
Jan Kehrmann, Jannis Menzel, Mohammadkarim Saeedghalati...
https://pubmed.ncbi.nlm.nih.gov/30202890Actively Recruiting
Age: 18Years +
All Genders
ID04330287
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
Led by University Hospital, Essen · Updated on 2024-07-30
2000
Participants Needed
5
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting the HIV/HEART Aging study to understand the occurrence, progression, and clinical course of cardiovascular diseases (CVD) in adults living with HIV. This prospective, multicenter trial involves outpatients from specialized HIV care units in the German Ruhr region who have a known HIV infection and stable disease status. The study aims to assess various cardiovascular conditions including coronary artery disease, cerebrovascular disease, peripheral arterial disease, heart failure, and cardiac valve issues over a 15-year follow-up period. Participants undergo comprehensive non-invasive cardiovascular examinations including medical history review, physical exams, and documentation of cardiovascular and antiretroviral therapy. Blood samples are collected for extensive laboratory tests measuring HIV-specific markers like CD4 count and HIV-1 RNA levels, as well as cardiovascular indicators such as lipid levels and brain natriuretic peptide (BNP). Non-invasive tests at the initial visit include heart rate and blood pressure measurements, electrocardiograms (ECGs), and optional transthoracic echocardiography, exercise ECG, cognitive assessments, and sample collections. Throughout the study, participants complete questionnaires about quality of life and health economics. Researchers monitor cardiovascular disease frequency and severity, disease progression, impact on atherosclerosis, and quality of life from baseline through the 15-year follow-up. Regular assessments adhere to standardized procedures. The study provides valuable long-term data on cardiovascular risks and outcomes in people living with HIV, supporting ongoing health management and care.
CONDITIONS
Brief Title
HIV-HEART Aging Study
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age > 18 years
- Known HIV-infection
- Signed informed consent
You will not qualify if you...
- Acute cardiovascular disease
- Unstable hemodynamic status in the three weeks before inclusion
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Baseline
Participants undergo a comprehensive non-invasive cardiovascular examination including medical history, physical examination, documentation of therapies, electrocardiogram, and optional tests such as echocardiography, exercise tests, and sample collection.
1 baseline visit (in-person)
Long-term Monitoring
Duration - Up to 15 years
Participants are followed up for up to 15 years to monitor cardiovascular risk, disease progression, and quality of life.
Periodic visits during follow-up as scheduled by the study
Trial Site Locations
Total: 5 locations
1
Universitätsklinikum Essen, Klinik für Dermatologie
Essen, Nordrheinwestfalen, Germany, 45147
Actively Recruiting
2
HIV physician pratice
Duisburg, North Rhine-Westphalia, Germany, 47259
Not Yet Recruiting
3
Institut für Medizinische Informatik, Biometrie und Epidemiologie
Essen, North Rhine-Westphalia, Germany, 45147
Active, Not Recruiting
4
University Hospital of Bochum, Department of Dermatology
Bochum, Germany, 44791
Not Yet Recruiting
5
HIV Outpatient Department
Dortmund, Germany, 44137
Not Yet Recruiting
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Research Team
S
Stefan Esser, PD MD
S
Sarah Albayrak-Rena
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Published Research Related To This Trial
B-type natriuretic peptides for the prediction of cardiovascular events and mortality in patients living with HIV: Results from the HIV-HEART study.
Nico Reinsch, Hendrik Streeck, Volker Holzendorf...
https://pubmed.ncbi.nlm.nih.gov/30711264Prediction of future cardiovascular events by Framingham, SCORE and asCVD risk scores is less accurate in HIV-positive individuals from the HIV-HEART Study compared with the general population.
C-A Schulz, L Mavarani, N Reinsch...
https://pubmed.ncbi.nlm.nih.gov/34028959Changes in body mass index, weight, and waist-to-hip ratio over five years in HIV-positive individuals in the HIV Heart Aging Study compared to the general population.
Laven Mavarani, Sarah Albayrak-Rena, Anja Potthoff...
https://pubmed.ncbi.nlm.nih.gov/36930373The Association of HIV-Specific Risk Factors with Cardiovascular Events in Addition to Traditional Risk Factors in People Living with HIV.
Laven Mavarani, Nico Reinsch, Sarah Albayrak-Rena...
https://pubmed.ncbi.nlm.nih.gov/37675901