Sildenafil for the Prevention of Right Heart Failure Following LVAD Implantation

Summary

Continuous-flow left ventricular assist devices (LVAD) move blood from the left ventricle (the largest chamber of the heart) to the aorta (the body's main artery) to help the heart better meet the needs of the body and to improve survival for patients with advanced heart failure (HF). The ability of the right ventricle (the large chamber on the right side of the heart) to keep up with the improved blood flow following LVAD greatly effects how well a person does following surgery. It is understood that a high pulmonary artery pressure (pressure in the blood vessel that takes blood from the right side of the heart to the lungs) measured before surgery, indicates that a higher risk of right heart failure exists after LVAD implantation. This is important because right heart failure after surgery is related to longer intensive care unit (ICU) and hospital stays, increased morbidity (other health problems) including organ failure and worse outcomes following heart transplant, and increased death rates. Sildenafil (Revatio®) has been approved by Health Canada in the treatment of pulmonary arterial hypertension (high blood pressure in the lungs) in patients with connective tissue disease. Sildenafil has not yet been approved by Health Canada for the treatment of pulmonary hypertension in heart failure. Sildenafil lowers blood pressure in the lungs and lessens the workload of the right ventricle (the right side of the heart). The purpose of this study is to determine if lowering blood pressure in the lungs, in heart failure patients at risk for developing right heart failure after LVAD implant, lowers the incidence of right heart failure, shortens ICU and hospital stays and reduces morbidity (other health problems) and mortality (death rates). This is an open label, single arm study. Everyone who participates in this study will receive sildenafil before and after LVAD surgery. It is expected that 24 patients who are scheduled to have LVAD implantation for advanced heart failure will be enrolled from 6 sites across Canada. Participants will be followed in the study for about 2 months.

Timeline

Start

2018-03-12

Primary completion

2021-09-30

Completion

2022-01

Publications

• Fine NM, Litwin O, Kent WDT, Holloway DD, Roy J, Miller RJH, Chih S, Davey RA, Isaac DL, Sharma N, Lyons KJ, Howlett JG. Feasibility of Sildenafil for the Prevention of Right Heart Failure After Continuous-Flow Left Ventricular Assist Device Implantation: The REVAD Trial. Can J Cardiol. 2024 Apr;40(4):659-661. doi: 10.1016/j.cjca.2023.11.017. Epub 2023 Nov 22. No abstract available.

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