Cholesterol Lowering With EVOLocumab to Prevent Cardiac Allograft Vasculopathy in De-novo Heart Transplant Recipients
Summary
The main goal of this study is to evaluate the effect of the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor evolocumab on cardiac allograft vasculopathy in de novo heart transplant recipients. Secondary objectives are to assess the impact of treatment on: i) cholesterol levels, ii) renal function, iii) inflammation, iv) quality of life, v) cardiac function as assessed by biomarkers and echocardiography, vi) the number of rejections, and (vii) safety and tolerability. As an exploratory outcome, the investigators will asses the effect of treatment on clinical events (death, myocardial infarction, cerebral stroke, cancer, end stage renal disease).
Timeline
- Start
- 2019-06-10
- Primary completion
- 2023-05-20
- Completion
- 2023-05-20
Outcome
Missed primary endpoint
paper the adjusted mean difference in the maximal intimal thickness between the 2 arms was 0.017 mm (95% CI: -0.006 to 0.040; P = 0.14). PMID 38934968 ↗
paper Twelve months of treatment with evolocumab substantially reduced low-density lipoprotein cholesterol but did not reduce maximal coronary intimal thickness in HTx recipients. PMID 38934968 ↗
Publications
- Karim SR, Jensen NM, Holck EN, Clemmesen TS, Christiansen EH, Jakobsen L, Chen Z, Sonka M, Karason K, Broch K, Solberg OG, Eiskjaer H. Impact of evolocumab on coronary physiology and microstructure in de-novo heart transplant recipients. J Heart Lung Transplant. 2026 Jan;45(1):26-36. doi: 10.1016/j.healun.2025.07.037. Epub 2025 Aug 20.
- Broch K, Lemstrom KB, Gustafsson F, Eiskjaer H, Karason K, Gjesdal G, Fagerland MW, Pentikainen M, Lommi J, Gude E, Andreassen AK, Clemmensen TS, Christiansen EH, Bjorkelund E, Berg ES, Arora S, Gullestad L. Randomized Trial of Cholesterol Lowering With Evolocumab for Cardiac Allograft Vasculopathy in Heart Transplant Recipients. JACC Heart Fail. 2024 Oct;12(10):1677-1688. doi: 10.1016/j.jchf.2024.04.026. Epub 2024 Jun 26.
- Broch K, Gude E, Karason K, Dellgren G, Radegran G, Gjesdal G, Gustafsson F, Eiskjaer H, Lommi J, Pentikainen M, Lemstrom KB, Andreassen AK, Gullestad L. Cholesterol lowering with EVOLocumab to prevent cardiac allograft Vasculopathy in De-novo heart transplant recipients: Design of the randomized controlled EVOLVD trial. Clin Transplant. 2020 Sep;34(9):e13984. doi: 10.1111/ctr.13984. Epub 2020 Aug 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Evolocumab | Monoclonal antibody | 420 mg | Subcutaneous |
Indications
No indication recorded.