HIV InfectionsHIV&HEARTNCT04156048
HIV&HEART Aging Study (12,5 Year Follow up)
An observational study of HIV Infections and Coronary Disease, run by University Hospital, Essen at 6 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
- 1,809 participants
- Where
- 6 sitesGermany
- Study dates
- 3 Jul 2017to 6 Nov 2019
- 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
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
University Hospital of Bochum, Department of Dermatology
Bochum, North Rhine-Westphalia, 44791
HIV Outpatient Department
Dortmund, 44137
HIV physician pratice
Duisburg, North Rhine-Westphalia, 47259
Universitätsklinikum Essen, Klinik für Dermatologie
Essen, Nordrheinwestfalen, 45147
Institut für Medizinische Informatik, Biometrie und Epidemiologie
Essen, North Rhine-Westphalia, 45147
Clinical Coordinating Center Leipzig
Leipzig, Saxony, 04107
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: 12,5 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 2019 (12,5 year Follow-up) 1806 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
- Exercise electrocardiogram
- Exercise Montreal Cognitive Assessment test
- Exercise the Grooved Pegboard test
- Blood collection
- 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 disease, myocardial infarction, HIV-associated neurocognitive disorders
- Medical subject headings
- HIV Infections, Coronary Disease, Myocardial Infarction, AIDS Dementia Complex, Heart Failure, Acquired Immunodeficiency Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular Diseases in HIV-infected Patients
Measured: Baseline up to 12,5 year follow up
Secondary outcomes (2)
Impact of classic cardiovascular risk factors of coronary artery disease, comorbidities and antiretroviral therapy
Measured: Baseline up to 12,5 year follow up
Impact of new HIV-specific risk factors of coronary artery disease, comorbidities and antiretroviral therapy
Measured: Baseline up to 12,5 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 posted7 Nov 2019
- Study start3 Jul 2017
- Primary completion31 Oct 2019
- Study completion6 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 1,809 participants (actual)
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
- Investigators
- Stefan Esser, PD, MD, Principal investigator, Departement of dermatology and venerology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04156048
- Sponsor's protocol ID
- 12-4970-BO B
- Acronym
- HIV&HEART
- Status last verified
- Feb 2020
- First submitted
- 21 Oct 2019
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. 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: 12,5 Year Follow up
- ClinicalTrials.gov ID
- NCT04156048
- Acronym / sponsor ID
- HIV&HEART / 12-4970-BO B
- Conditions
- HIV Infections, Coronary Disease, Myocardial Infarction, HIV Encephalopathy, Aging, Heart Failure
- Keywords
- HIV, AIDS, Antiretroviral therapy, Aging, Heart failure, coronary heart disease, myocardial infarction, HIV-associated neurocognitive disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,809 participants (actual)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- 3 Jul 2017 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 6 Nov 2019 (actual)
- First posted
- 7 Nov 2019 (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 2019 (12,5 year Follow-up) 1806 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
- Exercise electrocardiogram
- Exercise Montreal Cognitive Assessment test
- Exercise the Grooved Pegboard test
- Blood collection
- 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
Cardiovascular Diseases in HIV-infected Patients
Time frame: Baseline up to 12,5 year follow up
2 secondary outcomes
Impact of classic cardiovascular risk factors of coronary artery disease, comorbidities and antiretroviral therapy
Time frame: Baseline up to 12,5 year follow up
Impact of new HIV-specific risk factors of coronary artery disease, comorbidities and antiretroviral therapy
Time frame: Baseline up to 12,5 year follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
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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.
Stefan Esser, PD, MD principal investigator
Departement of dermatology and venerology
6 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 6 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: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular Diseases in HIV-infected Patients (time frame: Baseline up to 12,5 year follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2020.