ABOUT THIS STUDY
- 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
- 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
- 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
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