Clinical Trials

A Study to Evaluate GB002 in Adults with Pulmonary Arterial Hypertension (PAH)

Jacksonville, FL, Rochester, MN

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A Study to Evaluate GB002 in Adults with Pulmonary Arterial Hypertension (PAH)

Location:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
2
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The primary objective of this trial is to determine the effect of GB002 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 is to determine the effect of GB002 on improving exercise capacity in this population.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Open for enrollment	View complete study & contact information
Jacksonville, Fla.	Open for enrollment	View complete study & contact information

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Site IRB:
- Rochester, Minnesota: 20-012607
- Jacksonville, Florida: 20-012607
NCT ID:
NCT04456998
Sponsor Protocol Number:
GB002-2101

Exercise Training to Improve Pulmonary Haemodynamic and Right Ventricular Function in Heart Failure Patients with Pulmonary Hypertension

Jacksonville, FL

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Exercise Training to Improve Pulmonary Haemodynamic and Right Ventricular Function in Heart Failure Patients with Pulmonary Hypertension

Location:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

The purposed of this study are to investigate whether structured exercise training improves cardiac and pulmonary haemodynamic function, exercise capacity, and short-term clinical outcomes in heart failure (HF) patients with Pulmonary Hypertension (PH), and to develop a multivariable exercise pulmonary gas exchange ‘score’ that accurately differentiates HF patients with pre- and post-capillary PH (CpcPH) from HF patients with isolated post-capillary PH (IpcPH).

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Jacksonville, Fla.	Open for enrollment	View complete study & contact information

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Site IRB:
- Jacksonville, Florida: 20-011347
NCT ID:
NCT04909008

A Study of Sotatercept for the Treatment of Cpc-PH Due to HFpEF (MK-7962-007/A011-16)

Jacksonville, FL

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A Study of Sotatercept for the Treatment of Cpc-PH Due to HFpEF (MK-7962-007/A011-16)

Location:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
2
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The purpose of this study is to evaluate the effectiveness and safety of sotatercept versus placebo in adults with Cpc-PH due to HFpEF. Effectiveness is measured by change from baseline in pulmonary vascular resistance (PVR, primary endpoint) and 6-minute walk distance (6MWD, key secondary endpoint).

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Jacksonville, Fla.	Open for enrollment	View complete study & contact information

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Site IRB:
- Jacksonville, Florida: 21-013403
NCT ID:
NCT04945460
Sponsor Protocol Number:
A011-16

A Study to Assess the Aria CV Pulmonary Hypertension System to Treat Pulmonary Arterial Hypertension

Rochester, MN

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A Study to Assess the Aria CV Pulmonary Hypertension System to Treat Pulmonary Arterial Hypertension

Location:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
0
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The purpose of this study is to assess the safety and performance of the Aria CV Pulmonary Hypertension System in patients with pulmonary arterial hypertension.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Contact us for the latest status	View complete study & contact information

Print study details

Site IRB:
- Rochester, Minnesota: 20-009881
NCT ID:
NCT04555161
Sponsor Protocol Number:
ASPIREPH202001

A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (ELEVATE 2)

Jacksonville, FL, Rochester, MN

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A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (ELEVATE 2)

Location:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
2
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The purpose of this study is to evaluate the effect of Rodatristat Ethyl from baseline on pulmonary vascular resistance as measured at right heart catheterization.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Open for enrollment	View complete study & contact information
Jacksonville, Fla.	Open for enrollment	View complete study & contact information

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Site IRB:
- Rochester, Minnesota: 21-005388
- Jacksonville, Florida: 21-005388
NCT ID:
NCT04712669
Sponsor Protocol Number:
RVT-1201-2002

Open-label Extension Study of GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)

Jacksonville, FL

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Open-label Extension Study of GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)

Location:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
2
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The purpose of this extension study is to evaluate the long-term effects of GB002 (seralutinib) in subjects who previously participated in a GB002 PAH study.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Jacksonville, Fla.	Open for enrollment	View complete study & contact information

Print study details

Site IRB:
- Jacksonville, Florida: 22-002092
NCT ID:
NCT04816604
Sponsor Protocol Number:
GB002-2102

An Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan to Treat Patients with Pulmonary Arterial Hypertension

Scottsdale/Phoenix, AZ

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An Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan to Treat Patients with Pulmonary Arterial Hypertension

Location:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
3
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, Ariz.	Open for enrollment	View complete study & contact information

Print study details

Site IRB:
- Scottsdale/Phoenix, Arizona: 20-007516
NCT ID:
NCT04273945
Sponsor Protocol Number:
AC-055-315

A Study of AV-101 (Dry Powder Inhaled Imatinib) in Patients With Pulmonary Arterial Hypertension (PAH)

Jacksonville, FL

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A Study of AV-101 (Dry Powder Inhaled Imatinib) in Patients With Pulmonary Arterial Hypertension (PAH)

Location:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
2/3
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The purpose of this study is to evaluate the safety and efficacy of AV-101 (dry powder inhaled imatinib) in patients with Pulmonary Arterial Hypertension (PAH). The Phase 2b part of the study will assess three doses to establish an optimal dose for the Phase 3 part of the study. 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Jacksonville, Fla.	Open for enrollment	View complete study & contact information

Print study details

Site IRB:
- Jacksonville, Florida: 22-001938
NCT ID:
NCT05036135
Sponsor Protocol Number:
AV-101-002

A Study of Treprostinil to Treat Interstitial Lung Disease Pulmonary Hypertension

Rochester, MN

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A Study of Treprostinil to Treat Interstitial Lung Disease Pulmonary Hypertension

Location:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
2
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The purpose of this study is to see if patients with Pulmonary Arterial Hypertension related to Interstitial Lung Disease (ILD-PAH) will have impaired cardiac output reserve and leg blood flow during exercise, and inhlaed treprostinil will acutely increase exertional leg blood flow and cardiac output with preserved skeletal muscle O2 uptake efficiency, and to see a baseline hemodynamic improvement in exertional cardiac output with inhaled treprostinil will predict subsequent NYHA class improvement at 3 months with chronic inhaled treprostinil therapy.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Open for enrollment	View complete study & contact information

Print study details

Site IRB:
- Rochester, Minnesota: 22-004971
NCT ID:
NCT05564637

Vardenafil Inhaled for Pulmonary Arterial Hypertension PRN Phase 2B Study

Rochester, MN

See Details

Vardenafil Inhaled for Pulmonary Arterial Hypertension PRN Phase 2B Study

Location:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
2
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The purpose of this study is to evaluate the effects of RT234 on exercise parameters assessed by a specialized exercise test (Cardiopulmonary Exercise Test or CPET) in patients with pulmonary arterial hypertension (PAH).

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Contact us for the latest status	View complete study & contact information

Print study details

Site IRB:
- Rochester, Minnesota: 22-008973
NCT ID:
NCT04266197

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Search Results 1-10 of 26 for

A Study to Evaluate GB002 in Adults with Pulmonary Arterial Hypertension (PAH)

Exercise Training to Improve Pulmonary Haemodynamic and Right Ventricular Function in Heart Failure Patients with Pulmonary Hypertension

A Study of Sotatercept for the Treatment of Cpc-PH Due to HFpEF (MK-7962-007/A011-16)

A Study to Assess the Aria CV Pulmonary Hypertension System to Treat Pulmonary Arterial Hypertension

A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (ELEVATE 2)

Open-label Extension Study of GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)

An Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan to Treat Patients with Pulmonary Arterial Hypertension

A Study of AV-101 (Dry Powder Inhaled Imatinib) in Patients With Pulmonary Arterial Hypertension (PAH)

A Study of Treprostinil to Treat Interstitial Lung Disease Pulmonary Hypertension

Vardenafil Inhaled for Pulmonary Arterial Hypertension PRN Phase 2B Study

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