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Cardiovascular Risk Factor Management in HIV Infection

27. maj 2015 opdateret af: University Hospital, Basel, Switzerland

Efficacy of a Computerised Physician Reminder System to Control Cardiovascular Risk Factors in HIV-infected Patients Receiving Antiretroviral Therapy: A Nested Randomised Controlled Cluster Trial Within the Swiss HIV Cohort Study

There is growing evidence that antiretroviral therapy (ART) increases the risk of coronary heart disease (CHD) through metabolic side effects, such as dyslipidemia, insulin resistance, and type II diabetes. Prevalence of risk factors for CHD in HIV-infected individuals receiving ART in the Swiss HIV Cohort Study (SHCS) is high. This cluster randomised controlled trial is nested into the SHCS and will investigate whether physicians randomised to the routine provision of risk profiles from their patients receiving ART will improve the management of risk factors in HIV-infected patients compared to control physicians not routinely receiving such information. Risk profiles will be generated by the SHCS data center and provided to clinicians in all study centers.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Evidence from the D.A.D. study, an international cohort study which includes a large proportion of SHCS patients, suggests that exposure to antiretroviral therapy (ART) increases the risk of coronary heart disease (CHD) most likely due to ART induced metabolic changes like dyslipidemia, insulin resistance, and type II diabetes. The exact mechanisms for these metabolic changes and whether specific classes or combinations of ART are causally related to these changes are not known. Of males aged < 40 and > 40 years in the SHCS, 8.8% and 32.5% are at moderate (10% - 20%) and 1.7% and 6.9% at high (≥ 20%) risk of CHD in 10 years according to the Framingham algorithm. The overall percentage at moderate and high 10-year risk of CHD was 14.9% and 3.0%, respectively. Therefore, an intervention to reduce CHD risk among individuals at high risk for CHD is warranted. We propose a randomised controlled cluster intervention trial to reduce total cholesterol in all HIV-infected individuals in the SHCS (primary endpoint) and in those with greater than or equal to 10% 10 year risk of CHD based on the Framingham score (secondary endpoint). The intervention is the receipt of structured continuously updated information on CHD risk factors and treatment of CHD risk factors of HIV-infected patients. Randomisation will be done at the physician level and stratified by centre (7 centres of the SHCS, outpatient clinic or hospital), and size of patient volume for registered private practices. For physicians randomised to the intervention group, a flow sheet with information on risk factors and treatment status of CHD will be provided for each of their patients every 6 months by the SHCS data centre. Each centre and each physician treating SHCS patients will receive internationally and locally approved guidelines for the management of risk factors for CHD in HIV-infected patients. The intervention will be limited to 18 months. Our goal is a 7% reduction in total cholesterol (primary endpoint) between the intervention and the control group in the entire cohort. With alfa-error of 5%, power of 80% and a loss to follow-up of 10%, 408 patients per arm will be needed. Sample size calculations adapted to the cluster design of the trial show that we have sufficient power to detect a 12% reduction in total cholesterol in patients receiving ART and at moderate to high risk of CHD. Further secondary endpoints are a reduction of systolic and diastolic blood pressure and of overall Framingham risk score. We will additionally monitor whether changes in ART due to high risk of CHD, or treatment of CHD risk factors decreases the proportion of patients with non-sustained control of HIV-viremia. Data from this nested cluster trial will provide important information as to whether provision of an individual's CHD profile will improve monitoring and reduce CHD risk factors in HIV-infected patients in the SHCS.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

4097

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Schweiz
      • Berne, Schweiz, CH-3010
        • Klinik und Poliklinik für Infektiologie, Inselspital
      • Geneva, Schweiz, CH-1211
        • Division des Maladies Infectieuses, Hopital Universitaire Geneve
    • Canton St. Gall
      • St. Gallen, Canton St. Gall, Schweiz, CH-9007
        • Departement Innere Medizin Kantonsspital St. Gallen
    • Canton Ticino
      • Lugano, Canton Ticino, Schweiz, CH-6903
        • Ospedale civico Lugano
    • Canton Zurich
      • Zurich, Canton Zurich, Schweiz, CH-8091
        • Abteilung für Infektionskrankheiten & Spitalhygiene, Universitätsspital Zürich
    • Kanton Basel Stadt
      • Basel, Kanton Basel Stadt, Schweiz, CH-4031
        • University Hospital Basel
    • Vaud
      • Lausanne, Vaud, Schweiz, CH-1011
        • Division Maladies Infectieuses, Hopital Universitaire Vaudois (CHUV)

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

For analysis of the primary endpoint:

  • All individuals in the SHCS

    • aged 18 or older
    • have a cohort visit in the 12 months preceding the randomisation date with a complete baseline dataset on CHD risk factors

For analysis of secondary endpoints:

  • All individuals in the SHCS

    • aged 18 or older
    • have a cohort visit in the 12 months preceding the randomisation date with a complete baseline dataset on CHD risk factors
    • at least 3 months of ART and at moderate to high risk of CHD (10% 10 years risk of CHD according to the Framingham risk score).

Exclusion Criteria:

  • Pregnant females
  • Patients in the SHCS not receiving ART

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Updated CHD risk profiles
Provision of regularly updated CHD risk profiles
Adfærdsmæssigt: Updated CHD risk profiles
Provision of computer generated CHD risk profiles
Andre navne:
  • Computer assisted intervention to reduce CHD risk
Aktiv komparator: Guidelines
Physicians received guidelines only
Adfærdsmæssigt: Guidelines
provision of guidelines for CHD risk factor management only
Andre navne:
  • guidelines group

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Reduction in total cholesterol in the entire SHCS population
Tidsramme: 18 months
18 months

Sekundære resultatmål

Resultatmål
Tidsramme
The reduction in total cholesterol, systolic and diastolic blood pressure, and Framingham 10-year CHD risk score in individuals with a greater than or equal to 10% 10 year risk of CHD (according to the Framingham risk profile)
Tidsramme: 18 months
18 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital, Basel, Switzerland

Samarbejdspartnere

Bristol-Myers Squibb
Swiss National Science Foundation

Efterforskere

  • Ledende efterforsker: Heiner C Bucher, MD, Basel Institute for Clinical Epidemiology University Hospital Basel

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2006

Primær færdiggørelse (Faktiske)

1. oktober 2008

Studieafslutning (Faktiske)

1. februar 2010

Datoer for studieregistrering

Først indsendt

9. december 2005

Først indsendt, der opfyldte QC-kriterier

9. december 2005

Først opslået (Skøn)

12. december 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

28. maj 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. maj 2015

Sidst verificeret

1. maj 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SNF 3345-062041 SHCS 480
  • 480 (Swiss HIV Cohort Study)

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