Sildenafil for the Prevention of Right Heart Failure Following LVAD Implantation

Launched by UNIVERSITY OF CALGARY · Nov 22, 2017

Keywords

ClinConnect Summary

Initially implanted as a bridge to transplantation, LVADs are increasingly used for the purpose of destination therapy. About 250 patients/year will receive LVAD device therapy in 12 implanting Canadian centres. Outcomes after LVAD implantation are critically dependent on right ventricular (RV) function. Development of right heart failure (RHF) in LVAD patients has a direct effect on mortality and is associated with a prolonged length of intensive care unit (ICU) and hospital admission. RHF in LVAD patients leads to increased morbidity and is associated with worse outcomes after cardiac tra...

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Eligibility criteria

• Inclusion Criteria:
• • Patients aged \>18 years who are to receive durable (HeartMate II or III, or HeartWare HVAD) LVAD implantation for end-stage HF. Patients with all etiologies of HF will be included.
• • Patients identified as having an increased risk for post-operative RHF using pre-operative hemodynamic assessment criteria, defined as the presence of ≥ 1 of the following: i) Central venous pressure (CVP):mean pulmonary capillary wedge pressure (PCWP) ratio ≥ 0.63 ii) RV stroke work index \< 300 mmHg/mL/m2 iii) CVP ≥15 mmHg (CVP must be \>8 mmHg if applying one of the other criteria) iv) Pre-operative PVR ≥ 3 Wood Units (240 dynes/cm5/sec)
• • Systolic blood pressure ≥ 85 mmHg at study initiation
• • Women of childbearing potential must have a negative pregnancy test. Women must not be breast feeding. Heterosexually active women of child bearing potential must use an effective method of contraception during the study.
• • Ability to sign informed consent to participate
• Exclusion Criteria:
• • Preoperative INTERMACS level I or II
• • Preoperative systemic hypotension with mean arterial pressure \< 60 mmHg
• • Planned insertion of RV support device (either temporary or permanent)
• • Complex congenital heart disease where PVR measurement is not feasible or reliable (repaired or unrepaired)
• • Right sided fixed or dynamic obstruction to blood flow (i.e., pulmonary stenosis) with resting gradient ≥ 10 mmHg.
• • Previous organ transplantation
• • Preoperative use of any oral pulmonary vasodilator therapy or oral/inhaled/nitrate therapy
• • Patients requiring pre-operative hem - or peritoneal dialysis
• • Pre-enrollment treatment with other pulmonary dilating agents such as other PDE5 inhibitors, endothelin antagonists, prostacyclin analogues. Use of postoperative nitric oxide will be permitted (although not concomitantly with the study medication) as clinically indicated in the postoperative setting
• • Lack of ability to invasively measure right-sided pulmonary pressures
• • Refusal or inability to sign informed consent
• • Inability to accept preoperative study drug, or known sensitivity or allergy to sildenafil or any of its ingredients, or any other contra-indication to sildenafil as identified by product monograph
• • Participation in any other current interventional (drug or device) study