HIV InfectionsHIVHNCT04330287
HIV-HEART Aging Study
An observational study of HIV Infections and Coronary Disease, run by University Hospital, Essen at 5 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Coronary Disease, Myocardial Infarction
- How many people
- 2,000 participants
- Where
- 5 sitesGermany
- Study dates
- 11 May 2020to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: population affected by HIV
Who may be able to join
- Age > 18 years
- Known HIV-infection
- Signed informed consent
Who cannot join
- Acute cardiovascular disease
- Unstable hemodynamic status in the three weeks before inclusion
- Pregnancy
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites, 4 recruiting
- Not yet recruiting
University Hospital of Bochum, Department of Dermatology
Bochum, 44791
Anja Potthoff, MD, ++49 0234/509-1, a.potthoff@klinikum-bochum.de
- Not yet recruiting
HIV Outpatient Department
Dortmund, 44137
Martin Hower, MD, ++49 95320700, ID.ambulanz@klinikumdo.de
Julia Neumann, Study nurse, ++49 95320700, ID.ambulanz@klinikumdo.de
- Not yet recruiting
HIV physician pratice
Duisburg, North Rhine-Westphalia, 47259
Friedhelm Kwirant, MD, 0049203782173, FKwirant@t-online.de
- Recruiting
Universitätsklinikum Essen, Klinik für Dermatologie
Essen, Nordrheinwestfalen, 45147
Stefan Esser, MD, 0201/723-3878, stefan.esser@uk-essen.de
Sarah Albayrak-Rena, 0201/723-83721, sarah.albayrak-rena@uk-essen.de
- Active, not recruiting
Institut für Medizinische Informatik, Biometrie und Epidemiologie
Essen, North Rhine-Westphalia, 45147
About this study
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
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.
Read the 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 (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
- Conditions
- HIV Infections, Coronary Disease, Myocardial Infarction, HIV Encephalopathy, Aging, Heart Failure
- Keywords
- HIV, AIDS, Antiretroviral therapy, Aging, Heart Failure, coronary heart desease, myocardial infarction, HIV-associated neurocognitive disorders, weight gain
- Medical subject headings
- HIV Infections, Coronary Disease, Myocardial Infarction, AIDS Dementia Complex, Heart Failure, Weight Gain, Acquired Immunodeficiency Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: Baseline up to 15 year follow up
Detection of progression of cardiovascular diseases - especially of coronary artery disease - in patients with HIV-Infection
Calculation of Odds Ratio
Measured: Baseline up to 15 year follow up
Secondary outcomes (5)
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
Measured: Baseline up to 15 year follow up
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
Measured: Baseline up to 15 year follow up
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
Measured: Baseline up to 15 year follow up
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
Measured: Baseline up to 15 year follow up
Impact on cardiovascular risk, amount of atherosclerosis and life quality
in relation to cardiovascular and antiretroviral medication by calculating the 95%-Confidence interval
Measured: Baseline up to 15 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start11 May 2020
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Esser M.D., University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04330287
- Sponsor's protocol ID
- 14-5874-BO
- Acronym
- HIVH
- Status last verified
- Jul 2024
- First submitted
- 30 Mar 2020
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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 Coronary Heart Disease. J Infect Dis. 2019 Jan 9;219(3):497-508. doi: 10.1093/infdis/jiy524.
PubMed 30202890Reinsch 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 from the HIV-HEART study. Int J Cardiol. 2019 Apr 15;281:127-132. doi: 10.1016/j.ijcard.2019.01.066. Epub 2019 Jan 23.
PubMed 30711264Schulz 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 Framingham, SCORE and asCVD risk scores is less accurate in HIV-positive individuals from the HIV-HEART Study compared with the general population. HIV Med. 2021 Sep;22(8):732-741. doi: 10.1111/hiv.13124. Epub 2021 May 24.
PubMed 34028959Mavarani 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 Heart Aging Study compared to the general population. Infection. 2023 Aug;51(4):1081-1091. doi: 10.1007/s15010-023-02009-8. Epub 2023 Mar 17.
PubMed 36930373Mavarani L, Reinsch N, Albayrak-Rena S, Potthoff A, Hower M, Dolff S, Schadendorf D, Jockel KH, Schmidt B, Esser S. The Association of HIV-Specific Risk Factors with Cardiovascular Events in Addition to Traditional Risk Factors in People Living with HIV. AIDS Res Hum Retroviruses. 2024 Apr;40(4):235-245. doi: 10.1089/AID.2023.0055. Epub 2023 Oct 9.
PubMed 37675901
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04330287
- Acronym / sponsor ID
- HIVH / 14-5874-BO
- Conditions
- HIV Infections, Coronary Disease, Myocardial Infarction, HIV Encephalopathy, Aging, Heart Failure
- Keywords
- HIV, AIDS, Antiretroviral therapy, Aging, Heart Failure, coronary heart desease, myocardial infarction, HIV-associated neurocognitive disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- 11 May 2020 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- population affected by HIV
Key inclusion criteria (3 listed)
- Age > 18 years
- Known HIV-infection
- Signed informed consent
Key exclusion criteria (3 listed)
- Acute cardiovascular disease
- Unstable hemodynamic status in the three weeks before inclusion
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detection of frequency, severity of cardiovascular diseases - especially of coronary artery disease - in patients with HIV-Infection
Time frame: Baseline up to 15 year follow up
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%.
Detection of progression of cardiovascular diseases - especially of coronary artery disease - in patients with HIV-Infection
Time frame: Baseline up to 15 year follow up
Calculation of Odds Ratio
5 secondary outcomes
Impact on cardiovascular risk on amount of atherosclerosis
Time frame: Baseline up to 15 year follow up
Impact on life quality
Time frame: Baseline up to 15 year follow up
Impact on life quality
Time frame: Baseline up to 15 year follow up
Impact on life quality
Time frame: Baseline up to 15 year follow up
Impact on cardiovascular risk, amount of atherosclerosis and life quality
Time frame: Baseline up to 15 year follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Results publication: PubMed 30202890Kehrmann 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 Coronary Heart Disease. J Infect Dis. 2019 Jan 9;219(3):497-508. doi: 10.1093/infdis/jiy524.
- Results publication: PubMed 30711264Reinsch 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 from the HIV-HEART study. Int J Cardiol. 2019 Apr 15;281:127-132. doi: 10.1016/j.ijcard.2019.01.066. Epub 2019 Jan 23.
- Results publication: PubMed 34028959Schulz 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 Framingham, SCORE and asCVD risk scores is less accurate in HIV-positive individuals from the HIV-HEART Study compared with the general population. HIV Med. 2021 Sep;22(8):732-741. doi: 10.1111/hiv.13124. Epub 2021 May 24.
- Results publication: PubMed 36930373Mavarani 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 Heart Aging Study compared to the general population. Infection. 2023 Aug;51(4):1081-1091. doi: 10.1007/s15010-023-02009-8. Epub 2023 Mar 17.
- Derived from this study: PubMed 37675901Mavarani L, Reinsch N, Albayrak-Rena S, Potthoff A, Hower M, Dolff S, Schadendorf D, Jockel KH, Schmidt B, Esser S. The Association of HIV-Specific Risk Factors with Cardiovascular Events in Addition to Traditional Risk Factors in People Living with HIV. AIDS Res Hum Retroviruses. 2024 Apr;40(4):235-245. doi: 10.1089/AID.2023.0055. Epub 2023 Oct 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Coronary Disease, run by University Hospital, Essen at 5 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefan Esser, PD MD (00492017233878 ext. -3845, stefan.esser@uk-essen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of frequency, severity of cardiovascular diseases - especially of coronary artery disease - in patients with HIV-Infection (time frame: Baseline up to 15 year follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04330287, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.