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Cardiovascular Diseases in HIV-infected Patients HIV-HEART Study: 7.5 Years Follow-up

This study has been completed.
Sponsor:
Collaborators:
HIV-HEART Study Investigative Group
German Heart Failure Network
German Federal Ministry of Education and Research
Bristol-Myers Squibb GmbH & Co. KG
ViiV Healthcare
Gilead Sciences GmbH
Janssen-Cilag GmbH
Abbott
Boehringer Ingelheim Pharma GmbH & Co. KG
MSD Sharp & Dohmen GmbH
Information provided by (Responsible Party):
Stefan Esser M.D., University Hospital, Essen
ClinicalTrials.gov Identifier:
NCT01667068
First received: August 16, 2012
Last updated: October 27, 2014
Last verified: October 2014
  Purpose

Since the introduction of antiretroviral therapy life expectancy of HIV-infected persons is rising. Different cohorts are observing an increased risk for cardiovascular diseases in this aging HIV-infected population. Traditional cardiovascular risk factors like smoking are more frequent in HIV-infected persons. For example chronic inflammation due to HIV-infection and metabolic disorders also caused by some antiretroviral substances as special non-traditional risk factors in HIV-infected persons can influence the development of cardiovascular diseases additionally. Therefore new research focus in special risk profile associated with HIV-infection or antiretroviral treatment and prevention for HIV-infected patients is developing.

This present study is an ongoing prospective regional multicenter trial that was conducted to analyse the incidence, prevalence and clinical course of cardiovacular disorders in HIV-infected out-patients.

Cardiac disorders witch are associated with HIV are pericarditis, pleural effusion, pulmonary hypertension, dilated cardiomyopathy, heart failure, myocarditis, bacterial endocarditis and 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.


Condition Intervention
Coronary Heart Disease
Heart Failure
HIV
AIDS
Metabolic Syndrome
Other: Comprehensive non invasive cardiovascular examination

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: HIV-HEART STUDY: A Prospective, Epidemiologic and Multicentre Trial to Determine the Cardiovascular Risk in HIV-infected Patients

Resource links provided by NLM:


Further study details as provided by University Hospital, Essen:

Primary Outcome Measures:
  • Cardiovascular Diseases in HIV-infected Patients [ Time Frame: Baseline up to 7.5 follow-up to ] [ Designated as safety issue: No ]
    The detection of prevalence, aetiology, progression and severity of cardiovascular diseases - especially of coronary artery disease in HIV-infected patients.


Secondary Outcome Measures:
  • Cardiovascular Disorders in HIV-infected Patients HIV-HEART [ Time Frame: Baseline up to 5 years follow-up ] [ Designated as safety issue: No ]
    Complementary the study also investigates the impact of classic cardiovascular risk factors like gender, age, blood fat and also new HIV-specific risk factors of coronary artery disease like viral-load, CD4-cell count and stage of the infection. The HIV-HEART study will focus the impact of medication including cardiovascular and antiretroviral medication. Further secondary objectives will be examined, including economic costs and the subjectively quality of life of subjects with and without cardiovascular diseases in this patient population.


Biospecimen Retention:   Samples With DNA

Stored blood samples


Enrollment: 1481
Study Start Date: April 2012
Study Completion Date: October 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Regional Ruhrgebiets Cohort
HIV-positive patients in the German Ruhr-Region from out-patient clinics of hospitals and HIV-physicians pratices
Other: Comprehensive non invasive cardiovascular examination
  • Anamnesis with the participian
  • File recherche,Physical examination
  • Documentation of the carciovascular and antiretroviral medical therapy
  • Electrocardiogram
  • Transthoracic echocardiography
  • Exercise electrocardiogram
  • Measuring of the arterial media thickness
  • Exercise Montreal Cognitive Assesment test
  • Exercise the Grooved Pegboard test
  • Blood collection
  • Questionnaire to quality of life and health economics

Detailed Description:

A comprehensive detailed description of the study procedures had been previously published (European Journal of medical research 2007;12:243-248).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participiants were included in several cities of the Ruhrarea. Locations were Essen, Bochum, Dortmund and Duisburg 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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Acute cardiovascular disease
  • Unstable hemodynamic status in the three weeks before inclusion
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01667068

Locations
Germany
University Hospital of Bochum, Department of Dermatology
Bochum, Germany, 44791
HIV Outpatient Department
Dortmund, Germany, 44137
Health Center
Duisburg, Germany, 47249
University Hospital, Department of Dermatology and Venerology
Essen, Germany, 45147
University Hospital, West German Heart Center Essen
Essen, Germany, 45147
Clinical Coordinating Center Leipzig
Leipzig, Germany, 04107
Sponsors and Collaborators
University Hospital, Essen
HIV-HEART Study Investigative Group
German Heart Failure Network
German Federal Ministry of Education and Research
Bristol-Myers Squibb GmbH & Co. KG
ViiV Healthcare
Gilead Sciences GmbH
Janssen-Cilag GmbH
Abbott
Boehringer Ingelheim Pharma GmbH & Co. KG
MSD Sharp & Dohmen GmbH
Investigators
Principal Investigator: Stefan Esser, MD University Hospital, Essen
Principal Investigator: Till Neumann Neumann, MD University Hospital, Essen
  More Information

Additional Information:
Publications:

Responsible Party: Stefan Esser M.D., Academic Director, University Hospital, Essen
ClinicalTrials.gov Identifier: NCT01667068     History of Changes
Other Study ID Numbers: 12-4970-BO
Study First Received: August 16, 2012
Last Updated: October 27, 2014
Health Authority: Germany: Federal Ministry of Education and Research

Keywords provided by University Hospital, Essen:
Cardiac Diseases
HIV-Infection
AIDS
Antiretroviral Therapy
Cardiovascular Medication
Risk Factors
coronary heart disease
heart failure
metabolic syndrome

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Coronary Disease
Heart Diseases
Heart Failure
Metabolic Syndrome X
Myocardial Ischemia
Syndrome
Arterial Occlusive Diseases
Arteriosclerosis
Disease
Glucose Metabolism Disorders
Hyperinsulinism
Insulin Resistance
Metabolic Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014