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Detection of Frequency, Severity and Progression of Cardiovascular Diseases in Patients With HIV-infection.NCT01119729

Cardiovascular Diseases in HIV-infected Subjects (HIV-HEART Study)

An observational study of Detection of Frequency, Severity and Progression of Cardiovascular Diseases in Patients With HIV-infection. and Effect on Cardiovascular Risk and Life Quality by Age, Gender, Classic Cardiovascular Risk Factors,, run by University Hospital, Essen at 7 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Human immunodeficiency virus (HIV) infection has been associated with a variety of cardiovascular diseases. Even most industrialised countries exhibit a growing and aging population of HIV-infected patients in the majority treated with antiretroviral drugs, the investigators still do not know much about the impact of… Read more about this study

Who is it for?
Ages 18 years and older
How many people
803 participants
Where
7 sitesGermany
Study dates
Start not givento not given
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
  • Adult, Older adult

Study population: The study population included outpatients who were at least 18 years of age, had a known HIV-infection and exhibited a stable disease status within 4 weeks before inclusion of the trial. Patients were recruited during a 20-month period in a consecutive manner from September 2004 to May 2006. Written informed consent was obtained from all participants

Who may be able to join

  • Age > 18 years
  • Known HIV-infection
  • Outpatients
  • Written informed consent

Who cannot join

  • ● Acute cardiovascular disease or unstable hemodynamic status in the three weeks before inclusion
  • Pregnancy

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Germany7 sites

  • Department of Dermatology, University Hospital of Bochum

    Bochum, North Rhine-Westphalia, 44791

  • HIV Outpatient Department

    Dortmund, North Rhine-Westphalia, 44137

  • HIV Outpatients Department

    Duisburg, North Rhine-Westphalia, 47055

  • HIV Outpatient Department

    Duisburg, North Rhine-Westphalia, 47259

  • Department of Dermatology, University Hospital of Essen

    Essen, North Rhine-Westphalia, 45122

  • West German Heart Center Essen

    Essen, North Rhine-Westphalia, 45122

  • HIV Outpatient Department

    Essen, North Rhine-Westphalia, 45127

Other trials in Germany

About this study

Human immunodeficiency virus (HIV) infection has been associated with a variety of cardiovascular diseases. Even most industrialised countries exhibit a growing and aging population of HIV-infected patients in the majority treated with antiretroviral drugs, the investigators still do not know much about the impact of cardiovascular diseases in this group of patients. The present study is an ongoing trial that was conducted as a prospective and multicentre survey, being schemed to analyse the frequency and clinical course of cardiac disorders in HIV-infected patients.

Keywords
Cardiac Diseases • HIV-Infection • AIDS • Antiretroviral Therapy
Medical subject headings
Coitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01119729
Study groupRoleWhat they receive
HIV-infected OutpatientsNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of cardiovascular diseases

    Prevalence of cardiovascular diseases including coronary artery disease, congestive heart failure, peripheral arterial disease, cerebrovascular events, and valvular diseases.

Secondary outcomes (1)

  1. Prevalence of cardiovascular disorders

    Prevalence of cardiovascular disorders determined by electrocardiography, exercise testing, echocardiography, blood samples.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2010 (estimated)

Resources

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
803 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01119729
Sponsor's protocol ID
FKZ 01GI0205
Status last verified
May 2010
First submitted
7 May 2010
Last updated
10 May 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • Neumann T, Esser S, Potthoff A, Pankuweit S, Neumann A, Breuckmann F, Neuhaus K, Kondratieva J, Buck T, Muller-Tasch T, Wachter R, Prettin C, Gelbrich G, Herzog W, Pieske B, Rauchhaus M, Loffler M, Maisch B, Mugge A, Wasem J, Gerken G, Brockmeyer NH, Erbel R; HIV-HEART Study Investigative Group. Prevalence and natural history of heart failure in outpatient HIV-infected subjects: rationale and design of the HIV-HEART study. Eur J Med Res. 2007 Jun 27;12(6):243-8.

    PubMed 17666313

  • Neumann T. [HIV, AIDS and the cardiovascular risk]. Internist (Berl). 2008 Apr;49(4):429-30, 432-5. doi: 10.1007/s00108-008-2049-4. German.

    PubMed 18305915

  • Reinsch N, Buhr C, Krings P, Kaelsch H, Kahlert P, Konorza T, Neumann T, Erbel R; Competence Network of Heart Failure. Effect of gender and highly active antiretroviral therapy on HIV-related pulmonary arterial hypertension: results of the HIV-HEART Study. HIV Med. 2008 Aug;9(7):550-6. doi: 10.1111/j.1468-1293.2008.00602.x. Epub 2008 Jun 28.

    PubMed 18557952

  • Reinsch N, Buhr C, Krings P, Kaelsch H, Neuhaus K, Wieneke H, Erbel R, Neumann T; German Heart Failure Network. Prevalence and risk factors of prolonged QTc interval in HIV-infected patients: results of the HIV-HEART study. HIV Clin Trials. 2009 Jul-Aug;10(4):261-8. doi: 10.1310/hct1004-261.

    PubMed 19723613

  • Neumann T, Reinsch N, Neuhaus K, Brockmeyer N, Potthoff A, Esser S, Hower M, Neumann A, Mostardt S, Gelbrich G, Erbel R; fur die HIV-HEART-Studie sowie die Kompetenznetze Herzinsuffizienz und HIV/AIDS. [BNP in HIV-infected patients]. Herz. 2009 Dec;34(8):634-40. doi: 10.1007/s00059-009-3313-7. German.

    PubMed 20024643

  • Reinsch N, Esser S, Gelbrich G, Brockmeyer N, Potthoff A, Schadendorf D, Erbel R, Neumann T. Valvular manifestations of human immunodeficiency virus infection--results from the prospective, multicenter HIV-HEART study. J Cardiovasc Med (Hagerstown). 2013 Oct;14(10):733-9. doi: 10.2459/JCM.0b013e32835dc953.

    PubMed 24335884

  • 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. doi: 10.1007/s00392-012-0519-0. Epub 2012 Nov 2.

    PubMed 23117698

  • 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 Cardiovasc Dis. 2011;1(2):176-84. Epub 2011 Jul 30.

    PubMed 22254197

Questions about this trial

What is this clinical trial studying?

An observational study of Detection of Frequency, Severity and Progression of Cardiovascular Diseases in Patients With HIV-infection. and Effect on Cardiovascular Risk and Life Quality by Age, Gender, Classic Cardiovascular Risk Factors,, run by University Hospital, Essen at 7 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 4 inclusion and 2 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 10 May 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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?

Prevalence of cardiovascular diseases. 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 NCT01119729, which also lists 8 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 10 May 2010.

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