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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01196273
• Other study ID #: 09-4085
• Status: Completed
• Phase: N/A
• First received: May 7, 2010
• Last updated: June 27, 2012
• Start date: December 2009
• Est. completion date: December 2011

Study information

• Verified date: September 2010
• Source: University Hospital, Essen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Education and Research
• Study type: Observational

Clinical 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 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1424
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• AIDS
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Heart Failure
• HIV
• Metabolic Syndrome
• Metabolic Syndrome X
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Germany	University Hospital of Bochum, Department of Dermatology	Bochum
Germany	HIV Outpatient Department	Dortmund
Germany	University Hospital, Department of Dermatology and Venerology	Essen
Germany	University Hospital, West German Heart Center Essen	Essen
Germany	Clinical Coordinating Center Leipzig	Leipzig

Sponsors (11)

Lead Sponsor	Collaborator
University Hospital, Essen	Abbott, Boehringer Ingelheim, Bristol-Myers Squibb, German Competence Network for HIV/AIDS, German Federal Ministry of Education and Research, German Heart Failure Network, GlaxoSmithKline, HIV-HEART Study Investigative Group, Merck Sharp & Dohme Corp., ViiV Healthcare

Country where clinical trial is conducted

Germany, 

References & Publications (6)

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 — View Citation

Neumann T, Esser S, Potthoff A, Pankuweit S, Neumann A, Breuckmann F, Neuhaus K, Kondratieva J, Buck T, Müller-Tasch T, Wachter R, Prettin C, Gelbrich G, Herzog W, Pieske B, Rauchhaus M, Löffler M, Maisch B, Mügge A, Wasem J, Gerken G, Brockmeyer NH, Erbe — View Citation

Neumann T, Reinsch N, Neuhaus K, Brockmeyer N, Potthoff A, Esser S, Hower M, Neumann A, Mostardt S, Gelbrich G, Erbel R; für die HIV-HEART-Studie sowie die Kompetenznetze Herzinsuffizienz und HIV/AIDS. [BNP in HIV-infected patients]. Herz. 2009 Dec;34(8): — View Citation

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. Review. German. — View Citation

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 — View Citation

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;1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No