Cholesterol-lowering with EVOLocumab to prevent cardiac allograft Vasculopathy in De-novo heart transplant recipients: Design of the randomized controlled EVOLVD trial

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaperJournal articleResearchpeer-review

DOI

  • Kaspar Broch, University of Oslo
  • ,
  • Einar Gude, Rikshospitalet Oslo
  • ,
  • Kristjan Karason, Sahlgrenska University Hospital
  • ,
  • Göran Dellgren, Sahlgrenska University Hospital
  • ,
  • Göran Rådegran, Skåne University Hospital, Lund
  • ,
  • Grunde Gjesdal, Skåne University Hospital, Lund
  • ,
  • Finn Gustafsson, Rigshospitalet
  • ,
  • Hans Eiskjaer
  • Jyri Lommi, Heart and Lung Center, Helsinki University Hospital, Helsinki, Finland.
  • ,
  • Markku Pentikainen, Heart and Lung Center, Helsinki University Hospital, Helsinki, Finland.
  • ,
  • Karl B Lemström, Heart and Lung Center, Helsinki University Hospital, Helsinki, Finland.
  • ,
  • Arne K Andreassen, Rikshospitalet Oslo
  • ,
  • Lars Gullestad, Rikshospitalet Oslo, Oslo University Hospital

BACKGROUND: Cardiac allograft vasculopathy (CAV) is characterized by diffuse thickening of the arterial intima. Statins reduce the incidence of CAV, but despite the use of statins, CAV remains one of the leading causes of long-term death after heart transplant. Inhibitors of proprotein convertase subtilisin-kexin type 9 (PCSK9) substantially reduce cholesterol levels but have not been tested in heart transplant recipients.

METHODS: The Cholesterol lowering with EVOLocumab to prevent cardiac allograft Vasculopathy in De-novo heart transplant recipients (EVOLVD) trial (ClinicalTrials.gov Identifier: NCT03734211) is a randomized, double-blind trial designed to test the effect of the PCSK9 inhibitor evolocumab on coronary intima thickness in heart transplant recipients. Adults who have received a cardiac transplant within the past 4 - 8 weeks are eligible. Exclusion criteria include an estimated glomerular filtration rate < 20 mL/min/1.73 m2 , renal replacement therapy, or contraindications to coronary angiography with intravascular ultrasound. 130 patients will be randomized (1:1) to 12-months' treatment with evolocumab or matching placebo. The primary endpoint is the coronary artery intima thickness as measured by intravascular ultrasound.

CONCLUSION: The EVOLVD trial is a randomized clinical trial designed to show whether treatment with the PCSK9 inhibitor evolocumab can ameliorate CAV over the first year after heart transplant.

Original languageEnglish
Article numbere13984
JournalClinical Transplantation
Volume34
Issue9
Number of pages7
ISSN0902-0063
DOIs
Publication statusPublished - Sep 2020

    Research areas

  • cardiac allograft vasculopathy, cholesterol, heart transplant, randomized controlled trial, LONG-TERM SURVIVORS, EVEROLIMUS INITIATION, DISEASE, INTERNATIONAL SOCIETY, HYPERCHOLESTEROLEMIA, OUTCOMES, REGISTRY

See relations at Aarhus University Citationformats

ID: 191999188