AzTrials
AzTrials

Coronary Heart DiseaseNCT01196273

Cardiovascular Diseases in HIV-infected Patients HIV-HEART Study: 5 Years Follow-up

An observational study of Coronary Heart Disease and Heart Failure, run by University Hospital, Essen at 5 sites in Germany.

Completed

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

Official record
Search all trials

Trial summary

HIV-infection is associated not only with a reduced function of the immune system, but also linked with diseases of other organ systems, in particular with the heart. Heart conditions that have been described with HIV include Pericarditis, Pleural effusion Pulmonary hypertension (Venedic classification typ II) Dilated… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Heart Disease, Heart Failure, HIV
What is being tested?
Comprehensive non invasive cardiovascular examination
How many people
1,424 participants
Where
5 sitesGermany
Study dates
Dec 2009to Dec 2011
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: 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. Written informed consent was obtained from all participants.

Who may be able to join

  • Age > 18 years
  • Known HIV-infection
  • Written 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

  • University Hospital of Bochum, Department of Dermatology

    Bochum, 44791

  • HIV Outpatient Department

    Dortmund, 44137

  • University Hospital, Department of Dermatology and Venerology

    Essen, 45122

  • University Hospital, West German Heart Center Essen

    Essen, 45122

  • Clinical Coordinating Center Leipzig

    Leipzig, 04107

Other trials in Germany

About this study

Official title: HIV-HEART STUDY: A Prospective, Epidemiologic and Multicentre Trial to Determine the Cardiovascular Risk in HIV-infected Patients

HIV-infection is associated not only with a reduced function of the immune system, but also linked with diseases of other organ systems, in particular with the heart.

Heart conditions that have been described with HIV include

Read more
  • Pericarditis,
  • Pleural effusion
  • Pulmonary hypertension (Venedic classification typ II)
  • Dilated cardiomyopathy
  • Heart failure
  • Myocarditis
  • Bacterial endocarditis
  • Heart valve disorders In addition to previously stated disorders of the heart, the premature atherosclerosis of coronary arteries, a further even more important disease of the heart in this patient population, went into the focus of most HIV-researchers and physicians.

Premature atherosclerosis of coronary arteries results in coronary calcification, angina pectoris, myocardial infarction and sudden death. HIV-positive patients are at greater risk for a variety of heart-related conditions, including coronary artery disease. It is assumed, that HIV infection doubles the risk of a heart attack, according to recent research.

The reason for this link between HIV and heart-related conditions is unknown, but secondary infections that affect the heart muscle and coronary arteries have a greater chance of occurring in people with compromised immune systems. In addition, the HI-virus itself had been detected in the myocardium and might have an impact on the premature of cardiovascular diseases.

Furthermore, some of the medications used to treat HIV patients (antiretroviral therapy, ART) are assumed to have heart-related side effects.

Therefore, current treatment regimens for HIV infection have to be balanced against the marked benefits of antiretroviral treatment. Nevertheless, prevention of coronary heart disease should be integrated into current treatment procedures of HIV-infected patients.

The link between the heart and HIV is well established but not well understood. Therefore, further results are needed for efficient guidelines for the prevention, diagnostic and therapy of HIV-associated cardiovascular diseases.

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).

Being tested
Comprehensive non invasive cardiovascular examination
Keywords
Cardiac Diseases,, HIV-Infection,, AIDS,, Antiretroviral Therapy,, Cardiovascular Medication,, Risk Factors,, coronary heart disease,, heart failure,, metabolic syndrome
Medical subject headings
Coronary Disease, Heart Failure, Acquired Immunodeficiency Syndrome, Metabolic Syndrome, Heart Diseases

What participants receive

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

  • Comprehensive non invasive cardiovascular examinationOther

    Also called The examination includes:, - Anamnesis incl. admission form, Physical examination, Documentation of the medical therapy (incl. HAART)

    The examination includes:

    • Anamnesis incl. admission form
    • Physical examination
    • Documentation of the medical therapy (incl. HAART)
    • Electrocardiogram
    • Transthoracic echocardiography
    • Exercise electrocardiogram
    • 6 minute walk test
    • Blood collection
    • Questionnaire to quality of life and health economics
Study groups in NCT01196273
Study groupRoleWhat they receive
Regional Ruhrgebiets CohortNot described
Receives: Other: Comprehensive non invasive cardiovascular examination

What is being measured

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

  1. Cardiovascular Diseases in HIV-infected Patients

    The detection of prevalence, aetiology, progression and severity of cardiovascular diseases - especially of coronary artery disease - in HIV-infected patients.

    Measured: Baseline up to 5 years follow-up

Secondary outcomes (1)

  1. Cardiovascular Disorders in HIV-infected Patients HIV-HEART

    The study also investigates the impact of established risk factors and new HIV-specific risk factors of coronary artery disease such as, age, gender, virus-load, CD4-cell count. The HIV-HEART study will focus on the impact of medication including cardiovascular medication and antiretroviral medication. Further secondary objectives will be examined, including economic costs and quality of life of subjects with and without cardiovascular diseases in this patient population.

    Measured: Baseline up to 5 years follow-up

Timeline

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

  1. First posted8 Sep 2010 (estimated)
  2. Study startDec 2009
  3. Primary completionDec 2011
  4. Study completionDec 2011

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
1,424 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01196273
Sponsor's protocol ID
09-4085
Status last verified
Sep 2010
First submitted
7 May 2010
Last updated
28 Jun 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • 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

  • 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

  • Breuckmann F, Neumann T, Kondratieva J, Wieneke H, Ross B, Nassenstein K, Barkhausen J, Kreuter A, Brockmeyer N, Erbel R. Dilated cardiomyopathy in two adult human immunodeficiency positive (HIV+) patients possibly related to highly active antiretroviral therapy (HAART). Eur J Med Res. 2005 Sep 12;10(9):395-9.

    PubMed 16183552

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Heart Disease and Heart Failure, 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: finished, as of the sponsor's last update on 28 Jun 2012. 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?

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 5 years follow-up). 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 NCT01196273, which also lists 6 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 28 Jun 2012.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in