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Recruiting

Population:
CTEPH
Start Date:
November 1, 2018
End Date:
September 30, 2022
Phase:
Observational
Institution:
Queen's University
Study Summary
  • 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. 
Population:
Heart Failure PH
Start Date:
Tuesday, October 19, 2021
End Date:
Saturday, June 1, 2024
Phase:
Observational
Institution:
Mount Sinai Hospital, Canada
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[s] it aims to answer are 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.
Population:
PAH
Start Date:
June 1, 2021
End Date:
June 1, 2023
Phase:
Not Applicable
Institution:
University Health Network, Toronto
Study Summary
  • PET/MR as imaging biomarkers for cardiopulmonary dysfunction with a focus on Pulmonary hypertension (PH).
    The purpose of this study is to be able to Demonstrate correlation of combined PET/MR and plasma metabolomics markers in patients at risk of developing cardiopulmonary disfunction after RT.
Population:
Pediatric PH
Start Date:
June 20, 2018
End Date:
June 1, 2023
Phase:
Observational
Institution:
The Hospital for Sick Children
Study Summary
  • 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.
Population:
CTEPH
Start Date:
July 7, 2020
End Date:
May 14, 2024
Phase:
3
Institution:
Actelion
Study Summary
  • The purpose of the study is to evaluate the effect of macitentan 75 mg versus placebo on exercise capacity at Week 28 in participants with chronic thromboembolic pulmonary hypertension (CTEPH).
Population:
Pulmonary fibrosis associated with pulmonary hypertension
Start Date:
December 4, 2020
End Date:
December 1, 2022
Phase:
III
Institution:
Bellerophon Pulse Technologies
Study Summary
  • A randomized, double-blind, placebo-controlled dose escalation and verification study to assess the safety and efficacy of pulsed inhaled nitric oxide (iNO) in subjects at risk for pulmonary hypertension associated with pulmonary fibrosis on long term oxygen therapy (Part 1 and Part 2) - REBUILD
Population:
PAH
Start Date:
November 20, 2019
End Date:
May 12, 2023
Phase:
IB
Institution:
Laval University
Study Summary
  • The primary objective of this Phase 1B study is to confirm the safety of using olaparib in PAH patients, and precise the sample size of a future Phase 2 trial. In addition to safety, efficacy signals will thus be assessed.
Population:
PH and various lung diseases
Start Date:
Tuesday, November 10, 2020
End Date:
Thursday, December 21, 2023
Phase:
1
Institution:
Thunder Bay Regional Research Institute
Study Summary
  • The goal of this research is to optimize the MRI system to obtain ideal lung images using Hyperpolarized (HP) Noble and Inert Fluorinated Gases as contrast agents. Lung coils tuned to the frequencies of these gases will be used. This study will take place at TBRHSC in the Cardiorespiratory Department and in the Research MRI facility.
Population:
PAH
Start Date:
Monday, August 1, 2022
End Date:
Wednesday, September 30, 2026
Phase:
3
Institution:
Johns Hopkins University
Study Summary
  • The investigators' central hypothesis is that early combination therapy with two PAH-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 (WHO) functional class at 12 months after initiation of PAH treatment than therapy with sildenafil alone.
Population:
Pediatric Pulmonary Hypertension (PPH)
Start Date:
October 2014
End Date:
December 1, 2030
Phase:
Observational
Institution:
University of Colorado, Denver
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.

Population:
PAH
Start Date:
February 14, 2020
End Date:
June 30, 2022
Phase:
Not Applicable
Institution:
V-Wave Ltd
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.

Population:
PAH
Start Date:
March 15, 2021
End Date:
February 1, 2023
Phase:
II
Institution:
Altavant Sciences GmbH
Study Summary
  • The purpose of this study is to assess the safety and efficacy of Rodatristat Ethyl in pulmonary arterial hypertension (PAH) patients. Rodatristat Ethyl is a peripherally restricted TPH inhibitor being studied as a potential treatment for PAH. 
Population:
PAH
Start Date:
June 30, 2020
End Date:
October 31, 2023
Phase:
III
Institution:
Actelion
Study Summary
  • The purpose of this study is to demonstrate superiority of macitentan 75 milligrams (mg) in prolonging the time to the first clinical events committee (CEC)-adjudicated morbidity or mortality (M/M) event in participants with symptomatic pulmonary arterial hypertension (PAH) compared to macitentan 10 mg.

Population:
PAH
Start Date:
Friday, March 18, 2022
End Date:
Friday, June 30, 2028
Phase:
3
Institution:
Acceleron Pharma Inc.
Study Summary
  • The objective of this study is to evaluate the effects of sotatercept (MK-7962, formerly called ACE-011) treatment (plus background pulmonary arterial hypertension (PAH) therapy) versus placebo (plus background PAH therapy) on time to clinical worsening (TTCW) in participants who are newly diagnosed with PAH and are at intermediate or high risk of disease progression.
Population:
PAH
Start Date:
Thursday, December 2, 2021
End Date:
Sunday, December 1, 2024
Phase:
2 and 3
Institution:
Aerovate Therapeutics
Study Summary
  • IMPAHCT: Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial is a Phase 2b/Phase 3 study to evaluate the safety and efficacy of AV-101 (dry powder inhaled imatinib) in patients with Pulmonary Arterial Hypertension (PAH). The Phase 2b primary endpoint will be the placebo corrected change in pulmonary vascular resistance (PVR). The Phase 3 primary endpoint will be the placebo corrected change in 6-minute walk distance (6MWD) after 24 weeks of treatment.
Population:
PAH
Start Date:
August 30, 2018
End Date:
December 1, 2022
Phase:
III
Institution:
United Therapeutics
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 (WHO) Group 1 PAH.
Population:
CPC-PH
Start Date:
Wednesday, December 29, 2021
End Date:
Tuesday, January 9, 2024
Phase:
2
Institution:
Acceleron Pharma Inc.
Study Summary
  • The objective of this study is to evaluate the efficacy, safety and tolerability of sotatercept versus placebo in adults with Cpc-PH due to HFpEF. Efficacy is measured by change from baseline in pulmonary vascular resistance (PVR, primary endpoint) and 6-minute walk distance (6MWD, key secondary endpoint).
Population:
PAH
Start Date:
Wednesday, May 12, 2021
End Date:
Thursday, September 30, 2027
Phase:
3
Institution:
Acceleron Pharma Inc.
Study Summary
  • The primary objective of this open-label, LTFU study is to evaluate the long-term safety and tolerability of sotatercept when added to background 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.
Population:
Pediatric PAH
Start Date:
October 24, 2017
End Date:
February 29, 2024
Phase:
III
Institution:
Actelion
Study Summary
  • This is a prospective, multicenter, open-label, randomized, controlled, parallel Phase 3 study with an open-label single-arm extension period to evaluate pharmacokinetics (PK), safety and efficacy of macitentan in children with pulmonary arterial hypertension (PAH).
Population:
PAH
Start Date:
December 1,2021
End Date:
November 30, 2025
Phase:
III
Institution:
Acceleron Pharma Inc.
Study Summary
  • The objective of this study is to evaluate the effects of sotatercept (MK-7962, formerly called ACE-011) treatment (plus maximum tolerated background pulmonary arterial hypertension (PAH) therapy) versus placebo (plus maximum tolerated background PAH therapy) on time to first event of all cause death, lung transplantation, or PAH worsening-related hospitalization of ≥24 hours, in participants with World Health Organization (WHO) functional class (FC) III or FC IV PAH at high risk of mortality.
Population:
PAH
Start Date:
June 1, 2019
End Date:
December 1 2022
Phase:
Observational
Institution:
Laval University
Study Summary
  • The investigators propose to determine whether or not MS seen in PAH patients impairs mitochondrial functions through an IRS1/PPARg/PGC1-dependent mechanism, which will ultimately decrease skeletal muscle function and perfusion, and thus overall exercise capacity.
Population:
PAH
Start Date:
January 16, 2020
End Date:
December 9, 2024
Phase:
III
Institution:
Actelion
Study Summary
  • The purpose of this study is to evaluate whether the addition of selexipag to standard of care treatment delays disease progression in children with Pulmonary Arterial Hypertension (PAH) in comparison to placebo.

Enrolling by Invitation

Active (not recruiting)

Population:
Preterm Infant Pulmonary Hypertension
Start Date:
August 31, 2017
End Date:
December 2021
Phase:
Not Applicable
Institution:
Mount Sinai Hospital
Study Summary
  • The primary objective of this study is to develop new, sensitive, quantitative echocardiographic diagnostic criteria which will allow for the identification of extreme preterm neonates suffering from significantly high pressure in their pulmonary blood vessels, early in postnatal course, when the disease is likely to be most amenable to preventative/curative treatment.
Population:
PAH
Start Date:
March 2016
End Date:
December 2023
Phase:
III
Institution:
Bellerophon Pulse Technologies
Study Summary
  • 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 PULSE-PAH-004 to provide these patients with continued access to chronic iNO until the time of approval or development of iNO in PAH is discontinued.
Population:
Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction (LEPHT)
Start Date:
April 14, 2010
End Date:
December 31, 2023
Phase:
II
Institution:
Bayer
Study Summary
  • 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.
Population:
Pediatric Pulmonary Hypertension
Start Date:
August 2015
End Date:
December 1, 2022
Phase:
Observational
Institution:
Association for Pediatric Pulmonary Hypertension
Study Summary
  • 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.
Population:
PAH
Start Date:
July 29, 2019
End Date:
Tuesday, September 24, 2024
Phase:
III
Institution:
Actelion
Study Summary
  • This study aims to demonstrate that the FDC (fixed-dose combination) of macitentan and tadalafil is more effective than therapy with 10 mg of macitentan alone or 40 mg of tadalafil alone. This phase 3 study will evaluate the efficacy and safety at 16 weeks of an FDC (macitentan 10 mg and tadalafil 40 mg) against these two PAH-approved therapies given as monotherapy to further confirm the added value of the FDC.
Population:
Pediatric PAH
Start Date:
July 23, 2018
End Date:
December 31, 2026
Phase:
II
Institution:
Actelion
Study Summary
  • The purpose of this study to confirm the selexipag starting dose(s), selected based on pharmacokinetic (PK) extrapolation from adults, that leads to similar exposure as adults doses in children from greater than or equal to (>=) 2 to less than (˂) 18 years of age with Pulmonary Arterial Hypertension (PAH), by investigating the PK of selexipag and its active metabolite ACT-333679 in this population.
Population:
PAH
Start Date:
December 14, 2020
End Date:
November 2022
Phase:
II
Institution:
GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
Study Summary
  • The primary objective for this trial is to determine the effect of GB002 (seralutinib) on improving pulmonary hemodynamics in subjects with World Health Organization (WHO) Group 1 PAH who are Functional Class (FC) II and III. The secondary objective for this trial is to determine the effect of GB002 (seralutinib) on improving exercise capacity in this population.

Past Trials

Population:
PAH
Start Date:
September 28, 2017
End Date:
December 1, 2025
Phase:
II & III
Institution:
Northern Therapeutics
Study Summary
  • 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.
Population:
Sarcoidosis-associated Pulmonary Hypertension (SAPH)
Start Date:
February 26, 2021
End Date:
Sunday, September 15, 2024
Phase:
II
Institution:
Actelion
Study Summary
  • The aim of the present study is to investigate whether selexipag could be helpful to treat patients with another form of PH called sarcoidosis-associated pulmonary hypertension (SAPH).
Population:
Right Heart Failure
Start Date:
April 1, 2018
End Date:
September 30, 2022
Phase:
IV
Institution:
Ottawa Heart Institute Research Corporation
Study Summary
  • 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.
Population:
PAH
Start Date:
June 30, 2020
End Date:
October 31, 2023
Phase:
III
Institution:
Actelion
Study Summary
  • The purpose of this study is to demonstrate superiority of macitentan 75 milligrams (mg) in prolonging the time to the first clinical events committee (CEC)-adjudicated morbidity or mortality (M/M) event in participants with symptomatic pulmonary arterial hypertension (PAH) compared to macitentan 10 mg.
Population:
Pediatric PH
Start Date:
June 20, 2018
End Date:
June 1, 2023
Phase:
Observational
Institution:
The Hospital for Sick Children
Study Summary
  • 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.

     
Population:
PAH
Start Date:
May 2012
End Date:
August 2021
Phase:
III
Institution:
United Therapeutics
Study Summary
  • 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.
Population:
PAH
Start Date:
July 7, 2010
End Date:
April 2, 2021
Phase:
III
Institution:
Actelion
Study Summary
  • 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)
Population:
PAH
Start Date:
June 2021
End Date:
December 2021
Phase:
Not Applicable
Institution:
University of Calgary
Study Summary
  • This study will determine the feasibility of a mobile application-based home exercise rehabilitation program for patients with pulmonary hypertension. The principal investigator and co-investigator will be unaware of allocation until after the beginning of the exercise program. There will be no blinding after intervention begins, as is typical with studies of exercise intervention.
Population:
PAH
Start Date:
March 2020
End Date:
March 2021
Phase:
Not Applicable
Institution:
Laval University
Study Summary
  • In this study, we intend to evaluate the impact of a 12 weeks home-based rehabilitation program on peripheral muscle function and metabolism, focusing on lipid infiltration, oxidative metabolism and epigenetic factors that can be involved in metabolic syndrome, in patients with Pulmonary Arterial Hypertension.
Population:
CTEPH
Start Date:
January 25, 2021
End Date:
October 30, 2022
Phase:
II
Institution:
Actelion
Study Summary
  • Selexipag is available in many countries for the treatment of pulmonary arterial hypertension (PAH). Due to the similarities between PAH and chronic thromboembolic pulmonary hypertension (CTEPH) and the observed efficacy of other PAH medicines in CTEPH, it is believed that selexipag could benefit to patients with CTEPH. This study aims to assess the efficacy and safety of selexipag in subjects with inoperable or persistent/recurrent CTEPH.
Population:
PAH
Start Date:
August 22, 2019
End Date:
August 1, 2021
Phase:
I
Institution:
Steeve Provencher
Study Summary
  • The main objective of this proposal is to extend the investigator's preclinical findings on the role of epigenetics and DNA damage and Bromodomain-Containing Protein 4 (BRD4) inhibition as a therapy for a devastating disease, pulmonary arterial hypertension (PAH).
     
Population:
CTEPH
Start Date:
January 25, 2021
End Date:
October 30, 2022
Phase:
II
Institution:
Actelion
Study Summary
  • Selexipag is available in many countries for the treatment of pulmonary arterial hypertension (PAH). Due to the similarities between PAH and chronic thromboembolic pulmonary hypertension (CTEPH) and the observed efficacy of other PAH medicines in CTEPH, it is believed that selexipag could benefit to patients with CTEPH. This study aims to assess the efficacy and safety of selexipag in subjects with inoperable or persistent/recurrent CTEPH.
Population:
PAH
Start Date:
April 26, 2016
End Date:
December 2020
Phase:
IV
Institution:
University of Calgary
Study Summary
  • This is a prospective, multi-center, open-label, exploratory study with patients followed for a period of one year. The treatment duration period in this study begins at the initiation of ambrisentan plus riociguat and will continue for 12 months. Patients will come to clinic for a visit at month 4 and 12. Assessments will include Right Heart Catheterization, 6 Minute walk test, cardiac MRI, questionnaires and nt-Pro-BNP.