PH Research & Clinical Trials in Canada

In the past couple of decades, PH medical research has evolved immensely throughout the world. Medical professionals are delving deeper into the science and uncovering new information every day. And while this has taken place internationally, we are incredibly fortunate to have leading research and clinical trials taking place right here in Canada.

Please note that the below information was last updated in February 2019, and will be updated every four to six months meaning that changes in projects may have occured.

Disclaimer: PHA Canada is not responsible for errors and omitions. For more information or to express an interest in any of these research projects, speak to your PH medical team or visit ClinicalTrials.gov.


Recruiting:

Trial Name Population Start Date End Date Study Summary (from Authors) Phase (I, II, III or IV) Institution/Sponsor
A Study to Assess Whether Macitentan Delays Disease Progression in Children With Pulmonary Arterial Hypertension (PAH) (TOMORROW) PAH November 2017 July 2022 This is a –prospective, multicenter, open-label, randomized, controlled, parallel group, group-sequential, event-driven Phase 3 study to evaluate efficacy, safety and pharmacokinetics (PK) of macitentan in children. III Actelion
A Study To Evaluate Safety And Efficacy Of IV Sildenafil In The Treatment Of Neonates With Persistent Pulmonary Hypertension Of The Newborn Neonates With Persistent Pulmonary Hypertension Of The Newborn (Pphn) Or Hypoxic Respiratory Failure And At Risk For Pphn August 5, 2013 December 31, 2018 This study will evaluate whether IV sildenafil can reduce the time on inhaled nitric oxide treatment and reduce the failure rate of available treatments for persistent pulmonary hypertension of the newborn. III Pfizer
An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension PAH May 2012 May 2021 This study is an international, multi-center, open-label study designed to provide oral treprostinil (UT-15C) to eligible subjects with pulmonary arterial hypertension who have completed the TDE-PH-310 study. The purpose of this study is to assess the long-term safety of UT-15C and to assess the effects of long-term treatment with UT-15C on exercise capacity. III United Therapeutics
Bardoxolone Methyl in Patients With Connective Tissue Disease-associated Pulmonary Arterial Hypertension - CATALYST Connective Tissue Disease-Associated Pulmonary Arterial Hypertension October 2016 May 2020 This study assesses the safety and efficacy of bardoxolone methyl relative to placebo in patients with connective tissue disease-associated pulmonary arterial hypertension to determine the recommended dose range and evaluate the change from baseline in 6-minute walk distance (6MWD) following 24 weeks of study participation. III Reata Pharmaceuticals, Inc.
Dyspnea in Chronic Thromboembolic Pulmonary Hypertension Subjects will include 20 clinically stable patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH) recruited from the Pulmonary Hypertension outpatient clinics at Hotel Dieu Hospital, Kingston, Ontario. December 25, 2018 November 2019 Pulmonary embolism, or clots blocking the blood vessels of the lungs, is a common clinical condition requiring treatment with blood thinners. In most patients, recovery is complete. A small proportion of patients, however, develop complications (high blood pressure in the lung circulation, i.e. pulmonary hypertension). Persisting breathlessness during activity is a common symptom in many of these patients and leads to a reduced ability to engage in daily physical activity. The reason for this activity-related breathlessness remains uncertain and is the main question of the proposed study. Using new sophisticated technology, the investigators will determine the root causes of perceived breathing difficulty. The investigators will test the idea that breathlessness is fundamentally the result of increased drive to breathe from control centers in the brain. The investigators will measure drive to breathe by measuring the electrical activity descending from the brain to the main muscle of breathing - the diaphragm. The investigators will discover if the increased drive to breathe is due to accumulation of carbon dioxide in the blood as a result of poor blood perfusion of areas of the lung due to the effects of blockage by clots. The investigators also will investigate whether weakness and fatigue of the muscles of breathing, as a result of the high breathing demands that are present in patients with blood clots in the lungs, contribute to breathlessness. With this information it is hopeful that better treatment options will be developed to relieve this distressing symptom. 
  Queen's University
Extended Access Program to Assess Long-term Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension RANGER (RANGER) Patients with pulmonary hypertension (PH) who previously participated in controlled clinical studies with bardoxolone methyl April 18, 2017 December 2021 This extended access study will assess the long-term safety and tolerability of bardoxolone methyl in qualified patients with pulmonary hypertension (PH) who previously participated in controlled clinical studies with bardoxolone methyl. III Reata Pharmaceuticals, Inc.
Inflammatory Biomarkers of Pediatric Pulmonary Hypertension Patients of any age coming for cardiac catheterization and healthy controls coming for urology surgery
June 20, 2018 December 2019 To investigate if the inflammatory protein, high mobility group box 1 (HMGB1), along with other inflammatory mediators, is elevated in pediatric patients with congenital heart disease (CHD) and pulmonary hypertension as compared to those with CHD alone, or with healthy controls.   The Hospital for Sick Children
Long-term Ambrisentan Extension Study for Pediatric Patients Who Participated in AMB112529 PAH June 2011 October 2022 An open label, long term extension to Study AMB112529. All subjects may remain in the extension study for a minimum of six months. The primary objective is the long-term safety and tolerability of ambrisentan in the paediatric PAH population. Secondary objectives are all cause mortality and change from baseline in Study AMB112529 on efficacy parameters.

II GlaxoSmithKline
PARP-1 Inhibition in Pulmonary Arterial Hypertension The study population will include 6 well-characterized PAH patients that have been stable for >4 months on standard PAH-therapies, as per guidelines. August 16, 2017 December 2019 "At this stage, we propose a pilot study to assess the feasibility of the proposed trials in the PAH population. The overall HYPOTHESIS is that PARP1 inhibition with olaparib is a safe and effective therapy for PAH.
The primary objective of the study is to confirm feasibility, to support the safety of using olaparib in PAH patients, and precise the sample size of the coming Phase 1B trial. The feasibility of the comprehensive patient phenotyping that will be proposed within the phase 1B trial will thus be assessed, in addition to adverse events and efficacy signals. The design is open-label. A 4-week pre-treatment phase will allow ensuring that patients are on stable doses of medication. Patients will be given progressive doses of olaparib up to 400mg BID for 16 weeks."
I Laval University
Pediatric Pulmonary Hypertension Network (PPHNet) Informatics Registry (PPHNet) Pediatric Pulmonary Hypertension October 2014 December 2018 Patients are being asked to be in this research study because medical researchers hope that by gathering information about a large number of children with pulmonary hypertension over time, their understanding of the disease process will increase and lead to better treatment. Investigators believe that pulmonary hypertension in children is different than pulmonary hypertension in adults and this study will help us understand those differences.   University of Colorado, Denver
Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapy (REPLACE) PAH January 2017 January 2020 REPLACE is a randomized controlled study to confirm the potential clinical benefit of transition from PDE5i to riociguat. Satisfactory clinical response in patients who are on a stable dose of phosphodiesterase-5inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal will be compared between one group of patients randomized to maintain current treatment and another group where the PDE5i is replaced by riociguat. IV Bayer
Spironolactone Therapy in Chronic Stable Right HF Trial (STAR-HF) Adults with chronic, stable right HF April 1, 2018 January 2020 The purpose of this study is to evaluate the safety, tolerability and mechanistic effects of spironolactone, an aldosterone receptor antagonist, on sympathetic nervous system activity and right heart function and remodeling in patients with chronic right heart failure. IV Ottawa Heart Institute Research Corporation
Study of Angiogenic Cell Therapy for Progressive Pulmonary Hypertension: Intervention With Repeat Dosing of eNOS-enhanced EPCs (SAPPHIRE) Pulmonary Arterial Hypertension (PAH) on Top of Conventional Treatments September 28, 2017 October 2020 The SAPPHIRE clinical trial seeks to establish the efficacy and safety of repeated monthly dosing of autologous EPCs transfected with human eNOS (heNOS) in patients with symptomatic severe PAH on available PAH-targeted medical therapy. II Northern Therapeutics
The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension (TRITON) PAH May 2016 December 31, 2019 The objective of this clinical trial is to compare the efficacy and safety of an initial triple oral treatment regimen (macitentan, tadalafil, selexipag) versus an initial dual oral treatment regimen (macitentan, tadalafil, placebo) in newly diagnosed, treatment-naïve patients with pulmonary arterial hypertension. III Actelion
Tracking Outcomes and Practice in Pediatric Pulmonary Hypertension (TOPP-2) Pediatric Pulmonary Hypertension August 2015 December 2021 The TOPP-2 registry is an international, non-interventional, prospective registry including children and adolescents newly diagnosed with pulmonary hypertension (PH) to gain further insights in the disease course and long-term outcome of PH in childhood.   Association for Pediatric Pulmonary Hypertension


Enrolling by invitation:

Trial Name Population Start Date End Date Study Summary (from Authors) Phase (I, II, III or IV) Institution/Sponsor
Effect of Morphine on Dyspnea and 6-Minute Walk Distance in Pulmonary Arterial Hypertension Pulmonary Arterial Hypertension May 8, 2017 December 31, 2018 Despite advances in treatment and corresponding improvements in survival, patients with pulmonary arterial hypertension (PAH) remain highly symptomatic. In one survey of 315 patients with PAH, sixty-eight percent had moderate or severe dyspnea on exertion and 40% had a profound and clinically significant deficit in quality of life. Palliative care is being increasingly investigated in life-limiting cardiovascular diseases to alleviate symptoms. In PAH, its implementation is frequently delayed until end-of-life. Opioids are a common palliative care intervention, however the efficacy and safety of opioids for symptom relief in PAH has not been evaluated. II University Health Network, Toronto
Revatio Portal-Pulmonary Arterial Hypertension Trial (RePo1) Portal Pulmonary Arterial Hypertension October 2012 November 2018 The investigators propose the first prospective, double blind, randomized controlled trial of treatment for pulmonary arterial hypertension (PAH) related to underlying portal hypertension. Specifically the investigators will evaluate the potential efficacy and safety of sildenafil (Revatio) in a 16 week blinded, multicentre study. II University Health Network, Toronto


Active (Not Recruiting):

Trial Name Population Start Date End Date Study Summary (from Authors) Phase (I, II, III or IV) Institution/Sponsor
A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction (LEPHT) Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction April 14, 2010 June 6, 2012 The aim of this study is to assess whether increasing oral doses of Riociguat are safe and improve the well-being, symptoms and outcome in patients with pulmonary hypertension associated with left ventricular systolic dysfunction II
Bayer
BAY63-2521 - Long-term Extension Study in Patients With Chronic Thromboembolic Pulmonary Hypertension (CHEST-2) Patients who have completed 16 weeks of treatment in the double blind trial CHEST 1 July 1, 2009 December 31, 2018 Patients who have completed the 16 weeks treatment of the CHEST-1 trial (study number 11348) will be asked to participate in this long term extension study with BAY63-2521. The aim of the long term study is to collect additional information to evaluate the safety and tolerability of BAY63-2521. Patients will be treated with open label medication on their individual optimal dose between 0,5 mg - 2,5 mg tid.   Bayer
A Pharmacokinetics Study for Pediatric Participants With Pulmonary Arterial Hypertension PAH July 2012 April 2017 The purpose of this study to see how much study drug is in the blood after dosing children with pulmonary arterial hypertension (PAH) and to establish the correct dose for further clinical research. I & II Eli Lilly and Company
ACT-293987 in Pulmonary Arterial Hypertension PAH December 2009 February 2021 Long-term, single-arm, multicenter, open-label extension, Phase 3 study, to evaluate the safety and tolerability of ACT-293987 in patients with PAH who participated in the double-blind study AC-065A302 (GRIPHON) III Actelion
An Open-Label Extension Trial of UT-15C SR in Subjects With Pulmonary Arterial Hypertension (FREEDOM-EXT) PAH May 2006 December 2020 This study provides, or continues to provide, UT-15C SR (treprostinil diethanolamine) to eligible patients with pulmonary arterial hypertension who have completed protocols TDE-PH-202, TDE-PH-203, TDE-PH-205, TDE-PH-301, TDE-PH-302, TDE-PH-308 studies or any additional UT-15C SR clinical protocols evaluating subjects with PAH. The study assesses the long term safety of UT-15C and the effect of continued treatment with UT-15C on exercise capacity after one year of treatment. III United Therapeutics
BAY63-2521:Long-term Extension Study in Patients With Pulmonary Arterial Hypertension (PATENT-2) PAH March 2009 December 2018 Patients who have completed the 12 weeks treatment of the PATENT-1 trial (study number 12934) will be asked to participate in this long term extension study with BAY63-2521. III Bayer
Clinical Study of Pulsed, Inhaled Nitric Oxide Versus Placebo in Symptomatic Subjects With PAH (INOvation-1) PAH April 2016 December 2018 Phase 3, placebo controlled, double-blind, randomized clinical study to determine safety, tolerability, and efficacy of pulsed, inhaled nitric oxide (iNO) versus placebo in symptomatic subjects with pulmonary arterial hypertension (PAH). Part 1 and Part 2 III Bellerophon Pulse Technologies
Clinical Study to Assess the Long-term Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension (SERAPHIN OL) PAH October 2008 September 2021 The main objective of the AC 055 303/SERAPHIN OL study, which will follow the AC 055 302/SERAPHIN study, will be to assess the long-term safety and tolerability of ACT 064992 in patients with symptomatic PAH. III Actelion
Efficacy, Safety, and Tolerability Study of Pirfenidone in Combination With Sildenafil in Participants With Advanced Idiopathic PulmonaryFibrosis (IPF) and Risk of Group 3 Pulmonary Hypertension Group 3 PH This Phase IIb, randomized, placebo-controlled, multicenter, international study will evaluate the efficacy, safety, and tolerability of sildenafil or placebo added to pirfenidone (Esbriet) treatment in participants with advanced IPF and risk of Group 3 pulmonary hypertension (PH) who are on a stable dose of pirfenidone with demonstrated tolerability. Participants will be randomized to receive 1 year of treatment with either oral sildenafil or matching placebo while continuing to take pirfenidone. IIB Hoffmann-La Roche
Long-Term Extension Study of Inhaled Nitric Oxide (iNO) for PAH PAH March 2016 December 2018 An open-label, long-term study to evaluate the safety of inhaled nitric oxide (iNO) in subjects with pulmonary arterial hypertension (PAH) who participated in IK-7001-PAH-201 and to provide these patients with continued access to chronic iNO until the time of approval or when the trial is discontinued due to lack of efficacy. III Bellerophon Pulse Technologies
New International CTEPH Database CTEPH February 2015 January 2020 The New International CTEPH Database is a prospective, observational multi-center disease registry run by the International CTEPH Association (ICA), which will collect data in chronic thromboembolic pulmonary hypertension (CTEPH) patients worldwide. The registry will run for approximately 5 years. Its objective is to provide an overview on epidemiology of CTEPH, mode of diagnosis and treatment approaches worldwide as well as determinants of long-term outcomes as measured by New York Heart Association (NYHA) functional class and survival.   International CTEPH Association
Study of Ambrisentan in Subjects With Pulmonary Hypertension (ABS-LT) Eligible subjects are those participating in countries where ambrisentan is not yet commercially available. November 2008 October 2019 This Phase 3, international, multicenter, open-label study will monitor the long-term safety of ambrisentan in adults with pulmonary hypertension. The available ambrisentan doses for this study are 5 or 10 mg administered orally once daily; the approved doses of ambrisentan in the United States, Canada, and the European Union are 5 and 10 mg. Investigators will be able to adjust ambrisentan dose as clinically indicated. A minimum of 4 weeks between dose adjustments is required. Participants receiving other therapies for pulmonary hypertension that are not contraindicated for concomitant use with ambrisentan are permitted to enroll in this study and continue to receive such therapies. Participants enrolled in this study will receive treatment with ambrisentan until such time as the investigator or participant chooses to stop ambrisentan treatment, ambrisentan becomes commercially available, or the Sponsor stops the study.   Gilead Sciences