Sildenafil for the Prevention of Right Heart Failure Following LVAD Implantation
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|ClinicalTrials.gov Identifier: NCT03356353|
Recruitment Status : Not yet recruiting
First Posted : November 29, 2017
Last Update Posted : February 28, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|End Stage Heart Failure||Drug: Sildenafil Citrate||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is an open label single arm trial.|
|Masking:||None (Open Label)|
|Official Title:||Sildenafil for the Prevention of Right Heart Failure Following Continuous-Flow Left Ventricular Assist Device Implantation (The REVAD Study)|
|Estimated Study Start Date :||March 2018|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||September 2019|
Experimental: sildenafil citrate
Following enrolment, participants will be given an initial dose of sildenafil 20 mg. If tolerated, a schedule of 20 mg three times daily (tid) will be initiated. Dosage will be titrated over 3-4 days to the target dose of 40 mg tid. If the initial dose is not tolerated, the participant will be exited from the trial.
Drug: Sildenafil Citrate
20 mg tablets
Other Name: Revatio
- Pulmonary vascular resistance (PVR) [ Time Frame: From Baseline to postoperative day 14 ]Change in PVR reported in Wood Units as measured invasively via right heart catheterization (RHC)
- Right heart failure (RHF) [ Time Frame: From enrolment to day 55 (end of study) ]Proportion of participants experiencing RHF defined as INTERMACS criteria: i) Requirement of continuous-flow right ventricular assist device (RVAD) implantation for hemodynamic support any time prior to study end
- RHF [ Time Frame: Postoperative day 14 to postoperative day 55 (end of study) ]Proportion of participants experiencing RHF defined as INTERMACS criteria: ii) Prolonged inotropic support beyond postoperative day 14 directed for clinical RHF
- RHF [ Time Frame: From enrolment to postoperative day 55 (end of study) ]Proportion of participants experiencing RHF defined as INTERMACS criteria: iii) Discontinuation of study drug for the purpose of introduction of additional pulmonary vasodilator for the purpose of treatment of clinical RHF at any time during the study protocol
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03356353
|Contact: Nowell Fine, MDfirstname.lastname@example.org|
|Contact: Jonathan Howlett, MDemail@example.com|
|Principal Investigator:||Jonathan Howlett, MD||University of Calgary|