Status:
UNKNOWN
Sildenafil for the Prevention of Right Heart Failure Following LVAD Implantation
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Pfizer
Conditions:
End Stage Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 nee...
Detailed Description
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 Canadi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2022
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03356353
Start Date
March 12 2018
End Date
January 1 2022
Last Update
April 29 2021
Active Locations (4)
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1
University of Calgary
Calgary, Alberta, Canada
2
St. Boniface Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
3
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5
4
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7