Trial record 8 of 27 for:    " April 14, 2010":" May 14, 2010"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

This study has been completed.
Sponsor:
Collaborators:
HIV-HEART Study Investigative Group
German Heart Failure Network
German Competence Network for HIV/AIDS
German Federal Ministry of Education and Research
Bristol Myers Squibb GmbH & Co.KGaA
ViiV Healthcare
GlaxoSmithKline
Abbott
Boehringer Ingelheim Pharma GmbH & Co. KG
Merck Sharp & Dohme Corp.
Information provided by:
University Hospital, Essen
ClinicalTrials.gov Identifier:
NCT01196273
First received: May 7, 2010
Last updated: June 27, 2012
Last verified: September 2010
  Purpose

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 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.


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 5 years follow-up ] [ 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 ]
    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.


Biospecimen Retention:   Samples Without DNA

Stored blood samples


Enrollment: 1424
Study Start Date: December 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Regional Ruhrgebiets Cohort Other: Comprehensive non invasive cardiovascular examination

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
Other Names:
  • 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

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

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: NCT01196273

Locations
Germany
University Hospital of Bochum, Department of Dermatology
Bochum, Germany, 44791
HIV Outpatient Department
Dortmund, Germany, 44137
University Hospital, Department of Dermatology and Venerology
Essen, Germany, 45122
University Hospital, West German Heart Center Essen
Essen, Germany, 45122
Clinical Coordinating Center Leipzig
Leipzig, Germany, 04107
Sponsors and Collaborators
University Hospital, Essen
HIV-HEART Study Investigative Group
German Heart Failure Network
German Competence Network for HIV/AIDS
German Federal Ministry of Education and Research
Bristol Myers Squibb GmbH & Co.KGaA
ViiV Healthcare
GlaxoSmithKline
Abbott
Boehringer Ingelheim Pharma GmbH & Co. KG
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Stefan Esser, MD University Hospital, Essen
Principal Investigator: Till Neumann, MD University Hospital, Essen
  More Information

Additional Information:
Publications:

Responsible Party: PD Dr. med. Till Neumann MD, Dr. med. Stefan Esser MD, University Hospital
ClinicalTrials.gov Identifier: NCT01196273     History of Changes
Other Study ID Numbers: 09-4085
Study First Received: May 7, 2010
Last Updated: June 27, 2012
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:
Acquired Immunodeficiency Syndrome
HIV Infections
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Heart Failure
Metabolic Syndrome X
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014