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

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

• 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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Metabolic Syndrome; HIV; Coronary Heart Disease; AIDS
• Intervention / Treatment: Other: Comprehensive non invasive cardiovascular examination

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 1424

Contacts and Locations

Study Locations

• Germany
  • Bochum, Germany, 44791
    • University Hospital of Bochum, Department of Dermatology
  • Dortmund, Germany, 44137
    • HIV Outpatient Department
  • Essen, Germany, 45122
    • University Hospital, Department of Dermatology and Venerology
  • Essen, Germany, 45122
    • University Hospital, West German Heart Center Essen
  • Leipzig, Germany, 04107
    • Clinical Coordinating Center Leipzig

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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: Blood collection; Electrocardiogram; 6 minute walk test; Physical examination; Transthoracic echocardiography; The examination includes:; - Anamnesis incl. admission form; Documentation of the medical therapy (incl. HAART); Exercise electrocardiogram; Questionnaire to quality of life and health economics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline up to 5 years follow-up

Collaborators and Investigators

• Sponsor: University Hospital, Essen
• Collaborators: Bristol-Myers Squibb; GlaxoSmithKline; Merck Sharp & Dohme LLC; Boehringer Ingelheim; German Federal Ministry of Education and Research; Abbott; ViiV Healthcare; HIV-HEART Study Investigative Group; German Heart Failure Network; German Competence Network for HIV/AIDS
• Investigators: Principal Investigator: Till Neumann, MD, University Hospital, Essen

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: May 7, 2010
• First Submitted That Met QC Criteria: September 7, 2010
• First Posted (Estimate): September 8, 2010

Study Record Updates

• Last Update Posted (Estimate): June 28, 2012
• Last Update Submitted That Met QC Criteria: June 27, 2012
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: metabolic syndrome; heart failure,; Cardiac Diseases,; HIV-Infection,; AIDS,; Antiretroviral Therapy,; Cardiovascular Medication,; Risk Factors,; coronary heart disease,
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Insulin Resistance; Hyperinsulinism; Heart Failure; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Metabolic Syndrome
• Other Study ID Numbers: 09-4085