Ongoing Clinical Trials for Pulmonary Hypertension

Pulmonary hypertension is a serious condition affecting the blood vessels in the lungs, leading to increased blood pressure and strain on the heart. Currently, 15 clinical trials are underway across Europe, testing various medications and treatment approaches. These studies aim to improve exercise capacity, reduce symptoms, and enhance quality of life for patients with different forms of this disease, including pulmonary arterial hypertension, chronic thromboembolic pulmonary hypertension, and pulmonary hypertension associated with heart failure or lung disease.

Clinical trial locations

Long-term Safety Study of Tadalafil and Macitentan for Patients with Pulmonary Arterial Hypertension or Chronic Thromboembolic Pulmonary Hypertension

This study evaluates the long-term safety of a combination treatment using tadalafil and macitentan, as well as macitentan alone, for patients with two types of lung conditions affecting blood pressure in the lungs. The trial is designed for patients who have participated in previous studies of these medications.

Main inclusion criteria: Participants must have signed an informed consent form. Children under 18 require parental consent along with their own agreement if old enough. Participants must have been treated with macitentan, selexipag, or a combination of macitentan and tadalafil at the end of a previous study. No alternative access to the study medication should be available, and the participant should continue to benefit from the treatment. Women of childbearing potential must have negative pregnancy tests and use appropriate birth control methods throughout the study.

Main exclusion criteria: The specific exclusion criteria were not detailed in the source material, but generally would include conditions that could interfere with the safe use of the medications or accurate assessment of results.

Focus and goal: The study aims to monitor the safety of these treatments over an extended period, tracking any adverse effects and ensuring patient well-being. Regular health assessments and monitoring will be conducted throughout the study period, which extends until December 2027.

Investigational drugs: The study uses macitentan, an endothelin receptor antagonist that helps relax blood vessels and reduce blood pressure in the lungs. It is administered orally in tablet form and is currently approved for treating pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension.

Study of TX000045 for Pulmonary Hypertension in Heart Failure Patients with Preserved Ejection Fraction

This trial investigates TX000045 as a potential treatment for a specific type of high blood pressure in the lungs that occurs in people whose hearts pump normally but are too stiff to fill properly with blood.

Main inclusion criteria: Participants must be between 18 and 80 years old and either male or female who cannot have children. Women must be postmenopausal or have had certain surgeries. Participants must have a confirmed diagnosis of pulmonary hypertension with heart failure and preserved ejection fraction, with specific heart measurements from tests. They must have heart failure classified as NYHA functional class II-III and be able to walk between 100 and 450 meters in a 6-minute walk test. Medications for heart failure or cardiovascular disease must be stable for at least 30 days before screening.

Main exclusion criteria: Patients with other serious health conditions, those currently in another clinical trial, those who had a recent heart attack or stroke, those with severe liver or kidney disease, pregnant or breastfeeding women, those with a history of drug or alcohol abuse, and those who have had an organ transplant are excluded.

Focus and goal: The study aims to evaluate whether TX000045 can lower the pressure in the blood vessels of the lungs and improve breathing and physical activity. The 24-week treatment period includes regular monitoring through blood tests, echocardiograms, and 6-minute walk tests.

Investigational drug: TX000045 is administered through injection under the skin. It works by targeting specific pathways to help relax and widen blood vessels in the lungs, which can lower blood pressure and improve breathing.

Study on Dapagliflozin for Patients with Pulmonary Arterial Hypertension to Improve Exercise Capacity and Heart Function

This study examines whether dapagliflozin, a medication originally developed for diabetes, can improve heart and lung function in patients with pulmonary arterial hypertension who are already receiving other treatments.

Main inclusion criteria: Participants must have a confirmed diagnosis of pulmonary arterial hypertension, including idiopathic, heritable, or connective tissue disease-associated types. If diagnosed with group 4 pulmonary hypertension, no further invasive treatments should be planned. Symptoms must be classified as WHO functional class II-III. Participants must be stable on pulmonary vasodilator treatment for at least four weeks. Women of childbearing potential must use reliable birth control and have a negative pregnancy test. Participants must be 18 years or older, able to understand Danish, and capable of performing a cardiopulmonary exercise test.

Main exclusion criteria: Pregnant or breastfeeding women, those who had a recent heart attack or stroke, those with severe liver or kidney disease, current participants in other trials, those with drug or alcohol abuse history, and those with allergies to the study medication are excluded.

Focus and goal: The 90-day study evaluates how dapagliflozin affects exercise capacity and heart and lung function. Participants undergo various tests including cardiopulmonary exercise testing, walking tests, and heart function assessments.

Investigational drug: Dapagliflozin, marketed as Forxiga, is taken orally in tablet form. Originally used for diabetes, it helps the body remove excess sugar through urine, which may also help reduce the workload on the heart and improve blood flow.

Study on Sotatercept for Treating Pulmonary Hypertension in Patients with Heart Failure with Preserved Ejection Fraction

This extension study evaluates the long-term safety and tolerability of sotatercept in patients who have completed a previous study for pulmonary hypertension associated with heart failure where the heart pumps normally but is too stiff to fill properly.

Main inclusion criteria: Participants must have completed the previous study MK-7962-007 without discontinuing the study medication. They must have pulmonary hypertension and can be either male or female adults within the age range specified by the study.

Main exclusion criteria: Patients with other serious medical conditions, pregnant or breastfeeding women, those who participated in another trial within 30 days, those with allergic reactions to the study medication, uncontrolled high blood pressure, severe liver or kidney disease, drug or alcohol abuse history, and those unable to comply with study procedures are excluded.

Focus and goal: The study monitors participants for up to 42 months, assessing long-term safety, tolerability, and effectiveness. Regular assessments include measuring pulmonary vascular resistance and six-minute walk distance at various intervals.

Investigational drug: Sotatercept is administered as an injection under the skin. It targets specific proteins involved in blood vessel function, aiming to improve blood flow and reduce lung pressure. The medication is still under investigation for its long-term effects.

Study on the Effects of Mosliciguat for Patients with Pulmonary Hypertension Linked to Interstitial Lung Disease

This trial studies mosliciguat, an inhaled medication, for patients who have high blood pressure in the lungs due to scarring of lung tissue.

Main inclusion criteria: Participants must be willing and able to provide informed consent. They must have a diagnosis of interstitial lung disease confirmed by high-resolution CT scan, including idiopathic interstitial pneumonia, chronic hypersensitivity pneumonitis, or connective tissue disease-associated lung disease with reduced lung function. Participants must have confirmed pulmonary hypertension diagnosed by right heart catheterization and be able to walk at least 100 meters in six minutes.

Main exclusion criteria: Patients with other serious heart or lung diseases, those who had a recent heart attack or stroke, uncontrolled high blood pressure, pregnant or breastfeeding women, current participants in another trial, those with drug or alcohol abuse history, known allergies to the study medication, recent cancer diagnosis, severe liver or kidney disease, and active infections are excluded.

Focus and goal: The 16-week study assesses whether mosliciguat can reduce resistance in the blood vessels of the lungs, measured through regular right heart catheterizations. The study also tracks changes in walking distance and blood markers of heart stress.

Investigational drug: Mosliciguat is administered as an inhalation powder using a dry powder inhaler. It works by relaxing blood vessels in the lungs, which may help lower blood pressure and improve breathing.

Study on the Long-term Safety and Efficacy of Ralinepag for Patients with Pulmonary Arterial Hypertension

This open-label extension study evaluates the long-term safety and effectiveness of ralinepag in patients who have participated in earlier phases of research involving this medication.

Main inclusion criteria: Participants must be at least 18 years old and have pulmonary arterial hypertension. They must have signed an informed consent form and be willing to attend scheduled visits, follow the treatment plan, and complete all required tests. Participants must have completed necessary procedures from a previous ralinepag study. Both men and women must agree to use highly effective birth control during the study and for 30 days after the last dose.

Main exclusion criteria: Patients who have not participated in a previous Phase 2 or Phase 3 study of ralinepag, those with medical conditions other than pulmonary arterial hypertension, those outside the specified age range, and vulnerable populations are excluded.

Focus and goal: The study monitors various health indicators including NT-proBNP levels, six-minute walk distance, and overall quality of life. Regular assessments track how the medication impacts the condition over an extended period until the estimated study conclusion in December 2025.

Investigational drug: Ralinepag is taken as a prolonged-release tablet orally. It is a prostacyclin receptor agonist that helps relax blood vessels and improve blood flow, thereby reducing pressure in the lung arteries.

Study on the Safety and Effectiveness of MK-5475 for Adults with Pulmonary Hypertension and COPD

This study tests MK-5475, an inhalation powder, for patients who have high blood pressure in the lungs associated with chronic obstructive pulmonary disease.

Main inclusion criteria: Participants must be between 40 and 85 years old and have pulmonary hypertension associated with chronic obstructive pulmonary disease. Females must not be pregnant or breastfeeding and must either be unable to have children or use acceptable birth control. Participants must have had a right heart catheterization within the last 12 months meeting certain criteria, show signs of obstructive lung disease on pulmonary function tests, and have WHO Functional Class II to IV symptoms. Any use of supplemental oxygen, COPD medications, PDE5 inhibitors, antihypertensives, diuretics, or anticoagulants must be stable.

Main exclusion criteria: Patients with other types of pulmonary hypertension not associated with COPD, those who had a recent heart attack or stroke, uncontrolled high blood pressure, severe liver or kidney disease, pregnant or breastfeeding women, recent participants in other trials, those with drug or alcohol abuse history, and those with cancer not in remission are excluded.

Focus and goal: The 24-week study evaluates whether MK-5475 can improve walking distance in six minutes and assesses its safety. Regular monitoring includes blood tests, electrocardiograms, and physical examinations.

Investigational drug: MK-5475 is administered as an inhalation powder. It targets specific pathways to help relax and widen blood vessels in the lungs, potentially lowering blood pressure and improving breathing.

A Study of High-Concentration Oxygen Treatment in Patients with Heart Failure, Pulmonary Hypertension, and Coronary Microvascular Dysfunction

This study examines how breathing 100% oxygen affects blood flow and blood vessel resistance in patients with various heart and lung conditions.

Main inclusion criteria: Participants must be at least 18 years old and scheduled for coronary flow testing showing problems with small heart blood vessels, right heart catheterization to check for high lung blood pressure, or combined heart catheterization as part of evaluation for heart transplant or mechanical heart pump. Participants must have clear coronary arteries with less than 50% narrowing and be able to understand and sign an informed consent form. Both males and females can participate.

Main exclusion criteria: Those under 18 or over 65, pregnant or breastfeeding women, those with severe pulmonary diseases other than those being studied, recent heart attack or unstable heart conditions, inability to lie flat, current participation in other trials, known medication allergies, severe kidney or liver dysfunction, uncontrolled high blood pressure, blood clotting disorders, mental conditions affecting consent, active infections, use of interfering medications, inability to follow procedures, and history of adverse reactions to oxygen therapy are excluded.

Focus and goal: During a standard heart catheterization procedure, participants receive 100% oxygen for 10 minutes. Measurements of blood flow, blood pressure, and blood vessel resistance are taken at baseline, 5 minutes, and 10 minutes after starting oxygen administration.

Investigational approach: Pure oxygen at 100% concentration is administered as a medical gas through oral delivery in liquid form. The study evaluates how this affects blood circulation throughout the body, particularly in the heart and lungs.

Study on the Safety and Effectiveness of Apixaban, Edoxaban, and Phenprocoumon for Patients with Chronic Thromboembolic Pulmonary Hypertension Undergoing Balloon Pulmonary Angioplasty

This study compares different blood-thinning medications in patients with chronic blood clots in the lungs who are undergoing a procedure to open blocked blood vessels.

Main inclusion criteria: Participants must have a confirmed diagnosis of either chronic thromboembolic pulmonary hypertension or chronic thromboembolic disease without pulmonary hypertension. They must have been on anticoagulation treatment for at least three months and be considered inoperable, reluctant to undergo surgery, or have residual pulmonary hypertension after surgery. The blood clots must be reachable for balloon pulmonary angioplasty treatment. Both male and female adults can participate.

Main exclusion criteria: Patients with medical conditions other than the specified types of chronic thromboembolic conditions and those outside the specified age range are excluded.

Focus and goal: The study evaluates bleeding and lung injury within 24 hours after the balloon pulmonary angioplasty procedure. Secondary evaluations include allergic reactions, kidney problems, blood clots, long-term bleeding complications, mortality, and unplanned hospitalizations over a 30-day period.

Investigational drugs: The study compares direct oral anticoagulants like apixaban, edoxaban, rivaroxaban, and dabigatran with vitamin K antagonists like phenprocoumon and acenocoumarol. All medications are taken orally in tablet or capsule form and work by preventing blood clots through different mechanisms.

Study on Sotatercept for Treating Pulmonary Hypertension in Adults with Heart Failure

This study evaluates sotatercept for treating a specific type of high blood pressure in the lungs that occurs due to heart failure where the heart pumps normally but is too stiff to fill properly.

Main inclusion criteria: Participants must be between 18 and 85 years old and willing not to participate in other experimental drug or device trials. They must have a clinical diagnosis of heart failure with preserved ejection fraction, with specific heart measurements confirmed by right heart catheterization within 28 days. Participants must belong to New York Heart Association functional class II or III, be able to walk at least 100 meters in six minutes, and have been on stable medications for at least 30 days. Women of childbearing potential must have negative pregnancy tests, agree to ongoing testing, use effective birth control, and not breastfeed. Men must use condoms and not donate blood or sperm during the study.

Main exclusion criteria: Patients with other types of heart or lung diseases, recent heart attack or stroke, severe liver or kidney disease, pregnant or breastfeeding women, current participants in another trial, those with drug or alcohol abuse history, recent major surgery, uncontrolled high blood pressure, known allergies to the study medication, and those unable to walk the required distance are excluded.

Focus and goal: The study assesses effectiveness and safety of sotatercept compared to placebo, monitoring changes in blood vessel function and walking ability over time. Regular follow-up visits track health status and any side effects.

Investigational drug: Sotatercept is administered via injection under the skin. It targets specific proteins to help relax blood vessels and improve blood flow, aiming to reduce lung pressure and improve heart function.

Study on the Effectiveness and Safety of Ralinepag for Patients with Pulmonary Arterial Hypertension

This study evaluates how effective and safe ralinepag is in improving treatment outcomes for patients with pulmonary arterial hypertension.

Main inclusion criteria: Participants must be at least 18 years old with a primary diagnosis of symptomatic pulmonary arterial hypertension, which can be idiopathic, inherited, or caused by various conditions. They must have had a right heart catheterization within the last three years or be willing to have one during screening. Symptoms must be classified as WHO/NYHA functional class II to IV. Participants must be on stable doses of specific medications for at least 30 days and able to walk at least 150 meters in six minutes. Both men and women must agree to use highly effective birth control and not donate sperm or eggs during the study.

Main exclusion criteria: The specific exclusion criteria match those of the long-term safety study of ralinepag, focusing on patients who have not participated in previous ralinepag studies and those with conditions other than pulmonary arterial hypertension.

Focus and goal: The 48-week study monitors the time until a patient’s condition worsens according to specific criteria. Regular assessments track exercise capacity, overall health status, and various health indicators to gather comprehensive data on the treatment’s impact.

Investigational drug: Ralinepag is taken as a prolonged-release tablet orally. As a prostacyclin receptor agonist, it helps dilate blood vessels and improve blood flow, thereby reducing pressure in the lung arteries.

Summary

The 15 ongoing clinical trials for pulmonary hypertension demonstrate a broad research effort across multiple European countries, with Germany hosting the most trials, followed by several countries with strong participation including Italy, France, Spain, Belgium, and Poland. The studies focus on various forms of the disease, including pulmonary arterial hypertension, chronic thromboembolic pulmonary hypertension, and pulmonary hypertension associated with heart failure or lung disease.

Several medication classes are being investigated, including prostacyclin receptor agonists like ralinepag, endothelin receptor antagonists such as macitentan, soluble guanylate cyclase stimulators like riociguat and mosliciguat, and newer approaches with sotatercept. Some trials examine repurposing existing medications like dapagliflozin for this condition, while others evaluate combination therapies or compare different anticoagulation strategies.

Most studies emphasize long-term safety evaluation alongside effectiveness measures, with common outcome measurements including six-minute walk distance, pulmonary vascular resistance, and quality of life assessments. The trials vary in duration from 16 weeks to over three years, reflecting both acute effectiveness studies and long-term safety monitoring.

The geographic distribution of these trials provides broad access to experimental treatments across Europe, with most countries participating in multiple studies. This extensive research network suggests a coordinated international effort to advance treatment options for this serious condition affecting blood flow in the lungs and heart function.

#1 Clinical Trials Search in Europe

Pulmonary hypertension – Trials in Disease

Ongoing Clinical Trials for Pulmonary Hypertension

Clinical trial locations

Long-term Safety Study of Tadalafil and Macitentan for Patients with Pulmonary Arterial Hypertension or Chronic Thromboembolic Pulmonary Hypertension

Study of TX000045 for Pulmonary Hypertension in Heart Failure Patients with Preserved Ejection Fraction

Study on Dapagliflozin for Patients with Pulmonary Arterial Hypertension to Improve Exercise Capacity and Heart Function

Study on Sotatercept for Treating Pulmonary Hypertension in Patients with Heart Failure with Preserved Ejection Fraction

Study on the Effects of Mosliciguat for Patients with Pulmonary Hypertension Linked to Interstitial Lung Disease

Study on the Long-term Safety and Efficacy of Ralinepag for Patients with Pulmonary Arterial Hypertension

Study on the Safety and Effectiveness of MK-5475 for Adults with Pulmonary Hypertension and COPD

A Study of High-Concentration Oxygen Treatment in Patients with Heart Failure, Pulmonary Hypertension, and Coronary Microvascular Dysfunction

Study on the Safety and Effectiveness of Apixaban, Edoxaban, and Phenprocoumon for Patients with Chronic Thromboembolic Pulmonary Hypertension Undergoing Balloon Pulmonary Angioplasty

Study on Sotatercept for Treating Pulmonary Hypertension in Adults with Heart Failure

Study on the Effectiveness and Safety of Ralinepag for Patients with Pulmonary Arterial Hypertension

Summary

Ongoing Clinical Trials on Pulmonary hypertension

Testing the safety of stopping riociguat in patients with chronic thromboembolic pulmonary hypertension after successful balloon pulmonary angioplasty treatment

A study to evaluate the safety and effectiveness of inhaled treprostinil in patients with pulmonary hypertension associated with interstitial lung disease

A Study of Ferric Carboxymaltose to Improve Exercise Ability in Patients with Pulmonary Hypertension and Iron Deficiency

Long-term Safety Study of Tadalafil and Macitentan for Patients with Pulmonary Arterial Hypertension or Chronic Thromboembolic Pulmonary Hypertension

Vasopressin Versus Norepinephrine for Patients with Chronic Thromboembolic Pulmonary Hypertension After Pulmonary Endarterectomy Surgery

A study to evaluate the effectiveness of levosimendan in patients with pulmonary hypertension and heart failure with preserved ejection fraction.

A Study of High-Concentration Oxygen Treatment in Patients with Heart Failure, Pulmonary Hypertension, and Coronary Microvascular Dysfunction

Study on the Safety and Effectiveness of Apixaban, Edoxaban, and Phenprocoumon for Patients with Chronic Thromboembolic Pulmonary Hypertension Undergoing Balloon Pulmonary Angioplasty

Study of TX000045 for Pulmonary Hypertension in Heart Failure Patients with Preserved Ejection Fraction

Study on Sotatercept for Treating Pulmonary Hypertension in Adults with Heart Failure

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Pulmonary hypertension – Trials in Disease

Ongoing Clinical Trials for Pulmonary Hypertension

Clinical trial locations

Summary

Ongoing Clinical Trials on Pulmonary hypertension

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