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NCT Number: NCT02291081

A Prospective Observational Trial to Determine Cardiovascular Diseases in HIV-infected Patients

The HIV/HEART study (HIVH) is an ongoing, prospective, multicentre trial that was conducted to assess the incidence, the prevalence and the clinical course of cardiovascular diseases (CVD) in HIV-infected patients. The study population includes outpatients from specialized HIV-care units of the German Ruhr region, who were at least 18 years of age, were known to have a HIV-infection and exhibited a stable disease status within 4 weeks before inclusion into the trial. From March 2004 (Pilot phase) to May 2014 (7,5 year Follow-up) 1481 HIV+ patients were recruited in a consecutive manner. The standardised examinations included a targeted assessment of medical history and physical examination. Blood was drawn for comprehensive laboratory tests including HIV specific parameters (CD4 cell count, HIV-1 RNA levels) and cardiovascular items (lipid concentrations, BNP values and renal parameters). Furthermore, non-invasive tests were performed during the initial visit, including additional heart rate and blood pressure measurements, electrocardiogram (ECGs) and transthoracic echocardiography (TTE). Examinations were completed in accordance with previously defined standard operating procedures. CVD were defined as coronary, cerebrovascular, peripheral arterial disease, heart failure or cardiac vitium.

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Key information

Conditions

HIV-infection AIDS Dementia Complex Acquired Immunodeficiency Syndrome Aging Blood-Borne Infections Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Communicable Diseases Coronary Disease Coronary Heart Disease Dementia Genital Diseases HIV Infections HIV-encephalopathy Heart Diseases Heart Failure Immune System Diseases Immunologic Deficiency Syndromes Infarction Infections Ischemia Lentivirus Infections Mental Disorders Myocardial Infarction Myocardial Ischemia Necrosis Nervous System Diseases Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Vascular Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Bochum, Department of Dermatology, Bochum, North Rhine-Westphalia, Germany

Loading trial locations.

About this study

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

Comprehensive non invasive cardiovascular examination

  • Anamnesis
  • File recherche,Physical examination
  • Documentation of the cardiovascular and antiretroviral medical therapy
  • Electrocardiogram
  • Transthoracic echocardiography
  • Exercise electrocardiogram
  • Exercise Montreal Cognitive Assessment test
  • Exercise the Grooved Pegboard test
  • Blood collection
  • Questionnaire to quality of life and health economics

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comprehensive non invasive cardiovascular examination

Other

Comprehensive non invasive cardiovascular examination

  • Anamnesis with the participants
  • File recherche,Physical examination
  • Documentation of the cardiovascular and antiretroviral medical therapy
  • Electrocardiogram
  • Transthoracic echocardiography
  • Exercise electrocardiogram
  • Exercise Montreal Cognitive Assessment test
  • Exercise the Grooved Pegboard test
  • Blood collection
  • Questionnaire to quality of life and health economics

Primary outcomes

  1. Cardiovascular Diseases an deaths in HIV-infected Patients

    Time frame: Baseline up to 10 year follow-up

Secondary outcomes

  1. Impact of classic cardiovascular risk factors and new HIV-specific risk factors of coronary artery disease, comorbidities and antiretroviral therapy

    Time frame: Baseline up to 10 year follow-up

    Patients included in the pilot-baseline trial and additionally in the 5 and 7.5 year follow-up will be recruited again for the 10 year follow-up after giving informed consent. After including a total of 1481 patients in the previous phases, now both therapy-naive patients as well as patients being treated with new agents should be included.

Sponsors and collaborators

Lead sponsor

University Hospital, Essen

Other

Collaborators

  • Nico Reinsch M. D.
  • Till Neumann Prof. M. D.

Registry information

Official study title

A Prospective, Epidemiologic and Multicentre Trial to Determine the Cardiovascular Risk, New Cardiovascular Events and the Cardiovascular Diseases in HIV-infected Patients: 10 Year Follow-up

Acronym: HIV-HEART10

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Nov 14, 2014
Registry last updated
Oct 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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