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RESEARCH

Clinical Trials in Canada

In the past couple of decades, pulmonary hypertension 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. 

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How can I participate in pulmonary hypertension research?

Patient participation in research is essential to making scientific advancements in the diagnosis and treatment of pulmonary hypertension. Numerous early-stage and clinical-stage research studies are currently taking place in research centres throughout Canada. Check out the list below for more information on studies that are currently recruiting participants. For additional information, speak to your pulmonary hypertension team or visit ClinicalTrials.gov.

Disclaimer: This information is updated on a rolling basis. PHA Canada is not responsible for errors or omissions.

 

Thanks to advancements in research, many pulmonary hypertension treatments are available in Canada. However, they aren’t always available through public funding in every province and territory. This means people in some parts of the country don’t have equal access to the vital treatments they need. Visit our advocacy section to learn more and join us in representing a united pulmonary hypertension community.

Pediatric Pulmonary Hypertension Network (PPHNet) Informatics Registry

University of Colorado

Population:

Pediatric PH

Start Date:

October 1, 2014

End Date:

December 1, 2031

Observational

Phase:

STUDY SUMMARY

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.

A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients

United Therapeutics

Population:

PAH

Start Date:

August 30, 2018

End Date:

December 1, 2025

III

Phase:

STUDY SUMMARY

Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background therapy in subjects with World Health Organization Group 1 PAH.

Reducing Right Ventricular Failure in Pulmonary Arterial Hypertension (RELIEVE-PAH)

V-Wave Ltd

Population:

PAH

Start Date:

February 14, 2020

End Date:

December 31, 2026

-

Phase:

STUDY SUMMARY

The objectives of the RELIEVE-PAH study are to obtain first-in-human experience with the study device in patients with severe pulmonary arterial hypertension, including evidence of initial safety, device performance and possible signals of clinical effectiveness.

Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)

Duke University

Population:

PAH

Start Date:

March 5, 2020

End Date:

September 1, 2027

Observational

Phase:

STUDY SUMMARY

The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the pharmacokinetics of understudied drugs currently being administered to children per standard of care as prescribed by their treating provider.

A Long-term Follow-up Study of Sotatercept for PAH Treatment (SOTERIA)

Acceleron Pharma, Inc.

Population:

PAH

Start Date:

May 12, 2021

End Date:

February 5, 2031

III

Phase:

STUDY SUMMARY

The primary objective of this open-label, long-term follow-up study is to evaluate the long-term safety and tolerability of sotatercept when added to background pulmonary arterial hypertension (PAH) therapy in adult participants with PAH who have completed prior sotatercept studies. The secondary objective is to evaluate continued efficacy in adult participants with PAH who have completed prior sotatercept studies.

PET/MR Pre- and Post Radiotherapy for Cardiopulmonary Dysfunction Evaluation

University Health Network

Population:

Radiotherapy induced PH

Start Date:

June 1, 2021

End Date:

June 1, 2025

-

Phase:

STUDY SUMMARY

This study aims to demonstrate correlation of combined PET/MR and plasma metabolomics markers in patients at risk of developing cardiopulmonary disfunction after radiotherapy.

Hemodynamic Testing Strategies to Assess Pulmonary Hypertension in Heart Failure

Mount Sinai Hospital

Population:

Group 2 PH

Start Date:

October 19, 2021

End Date:

June 1, 2025

Observational

Phase:

STUDY SUMMARY

The goal of this observational study is to learn about heart function and high lung blood pressure in patients with heart failure. The main question it aims to answer is whether we can improve the ability to predict patients who will have complications after they receive treatment including heart transplant and left ventricular assist devices.

A Study of Sotatercept for the Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension Due to HFpEF (CADENCE)

Acceleron Pharma, Inc.

Population:

Group 2 PH

Start Date:

December 29, 2021

End Date:

February 20, 2027

II

Phase:

STUDY SUMMARY

This is a Phase 2, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of sotatercept versus placebo in adults with combined postcapillary and precapillary pulmonary hypertension (Cpc-PH) due to heart failure with preserved ejection fraction (HFpEF). Efficacy is measured by change from baseline in pulmonary vascular resistance (PVR, primary endpoint) and 6-minute walk distance (6MWD, key secondary endpoint).

Mono vs. Dual Therapy for Pediatric Pulmonary Arterial Hypertension

Johns Hopkins University

Population:

Pediatric PAH

Start Date:

August 1, 2022

End Date:

September 30, 2026

III

Phase:

STUDY SUMMARY

The investigators' central hypothesis is that early combination therapy with two pulmonary-arterial-hypertension-specific oral therapies that have been shown to be well tolerated in the pediatric population, sildenafil and bosentan, will result in better World Health Organization functional class at 12 months after initiation of PAH treatment than therapy with sildenafil alone.

Assessment of Recovery of Functional Capillary Surface Area in Patients Undergoing a Balloon Pulmonary Angioplasty for Chronic Thromboembolic Pulmonary Hypertension

Jewish General Hospital

Population:

CTEPH

Start Date:

January 30, 2023

End Date:

January 30, 2025

-

Phase:

STUDY SUMMARY

Many patients with chronic thromboembolic pulmonary hypertension (CTEPH) are treated with balloon pulmonary angioplasty [BPA] which mechanically opens the narrow pulmonary arteries. It is unclear how much downstream functional pulmonary capillary surface area [FCSA] is recovered during BPA. We plan to measure FCSAIn CTEPH patients, before and after a session of BPA.

TrEatment Approach in the Multimodal Era Registry (TEAM)

International CTEPH Association

Population:

CTEPH

Start Date:

April 12, 2023

End Date:

April 1, 2028

Observational

Phase:

STUDY SUMMARY

The goal of this observational patient registry is to learn how expert centers treat patients with chronic thromboembolic pulmonary hypertension (CTEPH).

Efficacy and Safety of Seralutinib in Adult Subjects With PAH (PROSERA)

Gossamer Bio

Population:

PAH

Start Date:

December 28, 2023

End Date:

October 1, 2025

III

Phase:

STUDY SUMMARY

The PROSERA Study is a Phase 3 clinical research study designed to help researchers understand whether an inhaled investigational product called seralutinib may be an effective and safe future treatment for adults with pulmonary arterial hypertension. The primary objective of the study is to determine the effect of seralutinib on improving exercise capacity in subjects with WHO Group 1 PAH who are FC II or III. The secondary objective for this trial is to determine time to clinical worsening.

LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF (LEVEL)

Tenax Therapeutics, Inc.

Population:

Group 2 PH

Start Date:

January 10, 2024

End Date:

July 1, 2027

III

Phase:

STUDY SUMMARY

This study will evaluate the efficacy of oral levosimendan compared with placebo in subjects with pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF) as measured by the change in 6-Minute Walk Distance.

A Study of HS135 for the Treatment of Pulmonary Arterial Hypertension in Adults

35Pharma Inc.

Population:

PAH

Start Date:

October 23, 2024

End Date:

July 1, 2027

I

Phase:

STUDY SUMMARY

A phase 1B open-label, multiple ascending dose study assessing the pharmacokinetics, safety, pharmacodynamics, and efficacy of HS135 added to background pulmonary arterial hypertension therapy.

Feasibility Trial for a Right Ventricular Failure Platform Trial (CRAVE)

University of Alberta

Population:

PH + RV dysfunction

Start Date:

February 1, 2025

End Date:

December 31, 2025

II

Phase:

STUDY SUMMARY

The primary objective of the CRAVE feasibility trial is to assess the feasibility of conducting a larger CRAVE platform trial by performing a randomized trial of 30 participants with pulmonary hypertension and right ventricular dysfunction, comparing empagliflozin or ranolazine plus standard of care to standard of care alone.

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