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

NCT01196273 | Completed DMC

• 1 other identifier: 09-4085
• Study Type: observational
• Target: 1,424
• Locations: 1 country
• Sites: 5

Brief 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 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.

Conditions

Coronary Heart Disease; Heart Failure; HIV; AIDS; Metabolic Syndrome

Keywords

Cardiac Diseases,; HIV-Infection,; AIDS,; Antiretroviral Therapy,; Cardiovascular Medication,; Risk Factors,; coronary heart disease,; heart failure,; metabolic syndrome

Outcome Measures

Primary Outcomes (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.

  Baseline up to 5 years follow-up

Secondary Outcomes (1)

• Cardiovascular Disorders in HIV-infected Patients HIV-HEART

  Baseline up to 5 years follow-up

Study Arms (1)

Regional Ruhrgebiets Cohort

Other: Comprehensive non invasive cardiovascular examination

Interventions

Comprehensive non invasive cardiovascular examination OTHER

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

Also known as: 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

Regional Ruhrgebiets Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Acute cardiovascular disease
• Pregnancy

Sponsors & Collaborators

• University Hospital, Essen: lead
• HIV-HEART Study Investigative Group: collaborator
• German Heart Failure Network: collaborator
• German Competence Network for HIV/AIDS: collaborator
• German Federal Ministry of Education and Research: collaborator
• Bristol-Myers Squibb: collaborator
• ViiV Healthcare: collaborator
• GlaxoSmithKline: collaborator
• Abbott: collaborator
• Boehringer Ingelheim: collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (5)

University Hospital of Bochum, Department of Dermatology

Bochum, 44791, Germany

Location

HIV Outpatient Department

Dortmund, 44137, Germany

Location

University Hospital, Department of Dermatology and Venerology

Essen, 45122, Germany

Location

University Hospital, West German Heart Center Essen

Essen, 45122, Germany

Location

Clinical Coordinating Center Leipzig

Leipzig, 04107, Germany

Location

Related Publications (6)

• 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.

  PMID: 18305915 RESULT

• 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.

  PMID: 18557952 RESULT

• 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.

  PMID: 19723613 RESULT

• 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.

  PMID: 20024643 RESULT

• 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.

  PMID: 17666313 RESULT

• 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.

  PMID: 16183552 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stored blood samples

MeSH Terms

Conditions

Coronary Disease; Heart Failure; Acquired Immunodeficiency Syndrome; Metabolic Syndrome; Heart Diseases

Interventions

Restraint, Physical; Blood Specimen Collection; Health Care Economics and Organizations

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Cardiovascular Diseases; Vascular Diseases; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative

Study Officials

• Stefan Esser, MD

  University Hospital, Essen

  PRINCIPAL INVESTIGATOR

• Till Neumann, MD

  University Hospital, Essen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 7, 2010
• First Posted: September 8, 2010
• Study Start: December 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: June 28, 2012

Record last verified: 2010-09

Locations

DE (5)