Pulmonary Vascular Disease Clinical Trials

As a patient at Cedars-Sinai, you will have access to the latest clinical trials and research for pulmonary vascular disease. Backed by a respected team of specialists and researchers, our clinical trials aim to further the advancement of diagnosing and treating your condition.

Questions? See the Clinical Trials FAQs.

Condition:

Pulmonary arterial hypertension

Key Inclusion Criteria

  • ≥18 to ≤75 years old
  • Body mass index >18.5 kg/m2
  • Symptomatic pulmonary hypertension
  • World Health Organization Group I pulmonary arterial hypertension associated with connective tissue disease

Summary:

The purpose of this study is to determine the safety and effectiveness of oral (given by mouth) bardoxolone methyl in individuals with pulmonary arterial hypertension (PAH) associated with connective tissue disease (CTD-PAH). To assess the effectiveness of the drug, researchers will evaluate how bardoxolone methyl affects exercise ability and measures of clinical improvement. Researchers will also observe how bardoxolone methyl affects selected measures of clinical worsening and other CTD-PAH disease symptoms. To evaluate safety, the study will monitor vital signs, laboratory assessments and ECGs, in addition to tracking any adverse events that may be experienced.

Condition:

Pulmonary embolism

Key Inclusion Criteria

  • 18-75 years old with body weight between 50-130 kg (110-286 lbs)
  • Admitted to the hospital with a clinical diagnosis of acute PE with an onset of symptoms in the five days prior to diagnosis categorized as low-risk, intermediate-risk or submassive PE and for whom catheter-based therapy is not planned

Summary:

This study focuses on individuals who have a blood clot in their lung(s) called a pulmonary embolism (PE). Normal standard of care for a blood clot is treatment with heparin followed by a blood thinner. The purpose of the study is to evaluate the safety of increasing doses of an investigational drug called DS-1040b when administered with standard-of-care treatment and to assess whether adding this drug to standard of care may help in the treatment of blood clots. Researchers aim to determine the best way to give DS-1040b and which dose of the drug is safe to use. Participants will be randomly assigned to receive either DS-1040b or placebo (inactive substance).

Key Inclusion Criteria

  • At least 18 years old
  • Diagnosed with an acute pulmonary embolism by computed tomography (CT) angiogram within the past 48 hours
  • Non-English speakers will be included with the use of the short form consent.

Summary

This study focuses on adults who have been diagnosed with an acute (new, sudden) pulmonary embolism by computed tomography (CT) angiogram within the past 48 hours. The purpose of the study is to determine whether a new software analysis technique applied to non-contrast CT scans can detect pulmonary emboli in patients diagnosed with acute pulmonary emboli by CT angiogram. Pulmonary embolism is most commonly diagnosed by performing a CT scan of the chest while injecting IV contrast to outline the blood vessels in the lungs and any blood clots in those vessels. 

Researchers believe that the study’s software analysis technique will help doctors diagnose pulmonary embolism from CT scans without having to inject IV contrast. This would be helpful to patients with kidney problems, as IV contrast poses risks of kidney damage.

Condition:

Pulmonary embolism

Key Inclusion Criteria

  • 18-75 years old
  • Chest computed tomography angiogram evidence of proximal pulmonary embolism (PE) with a filling defect in at least one main pulmonary artery or lobar artery
  • PE symptom duration ≤14 days 

Summary:

This study focuses on patients who have a blood clot in one or both of their pulmonary arteries (large blood vessels in the chest) that is interfering with blood flow through the heart and lungs. The purpose of the study is to determine how much of a pulmonary embolism (clot) can be dissolved when treated with a very low dose of a thrombolytic drug (clot buster) called alteplase (tPA) along with standard anticoagulant (blood thinning) therapy, compared to standard-of-care anticoagulant therapy alone. tPA is approved by the U.S. Food and Drug Administration (FDA) for breaking down blood clots in pulmonary embolism; however, it is not approved at the dosage the study is using.

Participants will be assigned to one of two study groups. The first group will receive the usual drug to treat pulmonary embolism (heparin) plus a placebo (inactive substance) IV infusion. The second group will receive the usual drug to treat pulmonary embolism (heparin) plus the tPA IV infusion.

Condition:

Pulmonary hypertension

Key Inclusion Criteria

  • At least 18 years old
  • Surgical implantation of LVAD
  • Evidence of pulmonary hypertension on baseline right heart catheterization

Summary:

The purpose of this study is to evaluate the safety and effects of an investigational drug called macitentan in patients with pulmonary hypertension (PH) after left ventricular assist device (LVAD) implantation. Pulmonary hypertension is a disorder of the blood vessels of the lungs, which can occur or worsen after implantation of an LVAD. Researchers will assess the effects of macitentan on the properties and function of the heart, as well as on blood pressure in the pulmonary arteries.

Condition:

Pulmonary hypertension

Key Inclusion Criteria

  • Patients newly treated with Opsumit defined as a new user of therapy, initiated less than or equal to 30 days prior to enrollment visit or at enrollment
  • Signed informed consent

Summary:

This observational study focuses on patients who are initiating therapy with a drug called Opsumit for the treatment of pulmonary arterial hypertension or another etiology (cause of disease). The purpose of the OPUS registry is to better understand the use of Opsumit in the clinical practice, including further characterization of the safety profile for the drug. Other goals include describing the demographic and clinical characteristics of patients treated with Opsumit. Opsumit is approved by the U.S. Food and Drug Administration for the treatment of pulmonary arterial hypertension.

Condition:

Pulmonary hypertension

Key Inclusion Criteria

  • At least 18 years old
  • Females must not be pregnant or lactating; males and females must use contraception
  • Confirmed diagnosis of World Health Organization (WHO) Group 3 pulmonary hypertension

Summary:

The purpose of this study is to evaluate the safety of a drug called treprostinil (Tyvaso) and the effectiveness of inhaled treprostinil in patients with pulmonary hypertension (PH) associated with interstitial lung disease (ILD) or combined pulmonary fibrosis and emphysema (CPFE). Researchers will examine the participant's ability to exercise after taking treprostinil.

Condition:

Heart failure, pulmonary vascular disease

Key Inclusion Criteria

  • At least 18 years old
  • Signs or symptoms of heart failure requiring treatment with at least one oral diuretic
  • Left ventricular ejection fraction (LVEF) ≥40%

Summary:

While several drugs are available to manage heart failure symptoms, no treatment has been approved specifically for left heart failure with preserved ejection fraction and pulmonary vascular disease. The purpose of the study is to determine the safety and effectiveness of a drug called macitentan in patients with this condition.

Condition:

Pulmonary hypertension, heart failure

Key Inclusion Criteria

  • 18–85 years old
  • Has undergone a right heart catheterization within 180 days of baseline assessment
  • Diagnosis of heart failure with a left ventricular ejection fraction ≥45%

Summary:

This study focuses on individuals who have pulmonary hypertension (PH) associated with left-sided heart failure with preserved ejection fraction (HFpEF). PH associated with HFpEF causes high blood pressure in the lungs due to the heart’s inability to function properly. The purpose of the study is to evaluate how oral treprostinil works to treat this condition. Researchers will examine the effect of oral treprostinil on the participant’s ability to exercise, as well as the time that PH associated with HFpEF remains stable, improves, or worsens.

Condition:

Idiopathic, heritable, connective tissue disease-associated and HIV-associated pulmonary arterial hypertension

Key Inclusion Criteria

  • Confirmed clinical diagnosis of IPAH, HPAH, PAH-CTD, PAH-HIV
  • NYHA Functional Class: II or III
  • 18-75 years old

Summary:

This study focuses on patients with pulmonary arterial hypertension (PAH) from the following subgroups: idiopathic PAH (IPAH), heritable PAH (HPAH), PAH associated with connective tissue disease (PAH-CTD) and PAH associated with HIV (PAH-HIV). The study is designed to evaluate the investigational use of a biologic product called CAP-1002. CAP-1002 consists largely of heart stem cells ("CDCs") grown from donated tissue from human heart muscle. The purpose of the study is to determine the maximum feasible dose and safety of CAP-1002 administered by central intravenous infusion (IV line) in PAH patients belonging to one of the subgroups listed above who have been started on PAH-specific medications. CAP-1002 will be used in addition to the participant’s regular treatment regimen.

Condition:
Pulmonary arterial hypertension

Key Inclusion Criteria

  • Completed the protocol-defined end-of-study (EOS) procedures and EOS visit in the original ralinepag study
  • Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other procedures
  • Both male and female participants agree to use a medically acceptable method of contraception

Summary:
This study focuses on individuals with pulmonary arterial hypertension (PAH) who have previously participated in another study with an investigational drug called ralinepag. PAH results from the small arteries (blood vessels) in the lungs becoming narrow or blocked. The purpose of the study is to evaluate the long-term effects of ralinepag on the participant's symptoms of PAH, ability to exercise, heart rate recovery (how quickly the heart rate slows down after a walking test) and quality of life. The study will also examine the long-term effects of ralinepag, when used with the patient's current treatment for PAH, on blood test results and study assessments as well as evaluate any side effects.

Condition:
Pulmonary arterial hypertension

Key Inclusion Criteria

  • 18-75 years old
  • Diagnosis of symptomatic World Health Organization Group 1 pulmonary arterial hypertension (PAH)
  • Has had a right heart catheterization performed at or within 365 days of screening that is consistent with the diagnosis of PAH

Summary:
The purpose of this study is to assess an investigational drug called ralinepag in the treatment of pulmonary arterial hypertension (PAH). PAH results from the small arteries (blood vessels) in the lungs becoming narrow or blocked. Researchers aim to determine how well ralinepag works when used with the current treatment for PAH, in addition to how it affects the ability to exercise, heart rate recovery (how quickly the heart rate slows down after a walking test) and quality of life. The study will also examine the effects of ralinepag, when used with the patient's current treatment for PAH, on blood test results and study assessments, as well as evaluate any side effects.