The purpose of this pilot study is to refine a mobile app, based on usability data, from 15 adults living with pulmonary hypertension (PH). The app is intended to reduce symptom burden and improve health-related quality of life for adults with PH, a chronic and debilitating cardiopulmonary condition. Participants will be asked to use the app and provide their thoughts about how to make it better by completing surveys and through interview. We also aim to assess readiness for broader implementation through surveys and targeted interviews with PH providers (N=15). Optimizing barriers and facilitators to implementation and gathering clinician perspectives will inform the design of a future randomized controlled feasibility trial.
This is a Phase 3, open-label, follow-up study to evaluate the long-term safety,
tolerability, and efficacy of sotatercept when added to background PAH therapy for the treatment of PAH. Participants enrolled in this study are from the following parent studies: PULSAR, SPECTRA, STELLAR, HYPERION, and ZENITH. Participants eligible to enroll in this study will have participated in and completed the requirements of the MK-7962-004 study (Amendment 07 or later). In this study, participants will receive open-label sotatercept . The duration of participation for each participant will vary based on their enrollment date, but it is anticipated to be up to 3 years.
This study is enrolling patients diagnosed with New York Heart Association (NYHA) Class II and III Heart Failure (HF). The main purpose of this study is to investigate the safety and effectiveness of the study device in helping to reduce Heart Failure Hospitalizations (HFH). The study is divided into 3 time periods: a screening period, implant/treatment period, and a follow-up period.
The study involves implanting a Cordella™ Pulmonary Artery Sensor during a right-heart catheterization, after which, you will be randomized into the treatment group (your study doctor will use the data from your daily weight, blood pressure, heart rate measurements, and your daily sensor readings to treat your heart failure) or the active control group (your study doctor will only use the data from your daily weight, blood pressure, and heart rate measurements to treat your heart failure). You will have a 66% (2 in 3) chance of being in the treatment group and a 33% (1 in 3) chance of being in the active control group. Randomization is much like a like drawing straws where you have a 66/33 chance of being assigned to the treatment group or the active control group.
After you have been implanted for 6 months, you and your study doctor will be "unblinded" (able to see) the daily measurements from the Cordella™ Pulmonary Artery Sensor System. Follow-up visits will occur at 1, 3, 6, 12, 18, and 24 months, then annually up to 5 years.
Risks include complications from the implant procedure (bleeding, infection, damage to blood vessels, allergic reactions), risks from contrast dye, anesthesia, or medications (e.g., bleeding from blood thinners), and potential unknown device-related risks.
This study is the first time the drug PF-07868489 will be tested in humans. The goal is to see if the drug is safe and how the body reacts to it. In the first part, healthy adults will receive a single dose to check for any side effects and how the drug moves through the body. In the second part, patients with a specific lung condition called Pulmonary Arterial Hypertension (PAH) will receive multiple doses to see if the drug helps their condition and to further check its safety and effects.
The purpose of this study is to observe and capture demographic characteristics,
treatment patterns, and clinical outcomes of interest for patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) to further clinical understanding of the epidemiological landscape and outcomes of the disease and treatment. This study will follow patients for up to 5 years after enrollment.
The purpose of the study is to evaluate the safety and how well the medication sotatercept works versus placebo in treating Heart Failure with a Preserved Ejection Fraction. The study will also look at information obtained from the tests performed as part of the study to see if subjects have improvement in symptoms of heart failure. Participation in this study will last approximately 26 months. During the study period subjects will be asked to attend regular study visits with the research coordinator. These visits will include such activities as blood tests, questionnaires, physical evaluation by a study doctor, a right heart catheterization with exercise, echocardiogram, and 6 minute hall walks. There will be 35 visits as part of participation in this clinical trial.
Participants will be randomized to either the treatment group (and receive the medication) or the control group (and not receive the medication). Subjects will have a 2:1 chance of receiving the study medication during their participation in the trial. The treatment assignment is determined by randomization, where a computer selects at random which treatment group you will be in (like drawing straws). Neither the subject, nor the blinded personnel will know which group subjects are in. Neither the subject nor the study doctor will decide what group subjects are assigned. Participants from the placebo group in CADENCE who enter HARMONIZE at Visit 9a will be randomized 1:1 to one of the active treatment groups. Participants from an active treatment group in CADENCE entering HARMONIZE after Visit 9a will be allocated to continue in the same treatment group (ie, sotatercept dose level) as in CADENCE.
This study is investigating the drug, called mosliciguat, for the treatment of PH-ILD. Participation in the study may last for about 4 ½ years, although the actual time of participation may be shorter or longer. Part 1 of the study will take about 6 months. Part 2 of the study could last up to about 4 years. During the study, participants will be required to make clinic visits in person and at times will need to meet with study staff over the phone/video. At some of the clinic visits, participants will have blood drawn and have procedures to test their lungs and heart function. Participants will be randomly assigned to get mosliciguat or placebo in Part 1. In Part 2, all participants will get mosliciguat. Approximately 120 people will participate in this study.
This study is for patients who have heart failure with pulmonary hypertension. Heart failure means that the heart cannot pump blood as well as normal. Pulmonary hypertension happens when the pressure in the blood vessels leading from the heart to the lungs is too high, blood flowing through the lungs is limited, and the pressure in the lungs increases when you are physically active, causing symptoms of shortness of breath and tiredness.
The study uses the Gradient device to see if can help treat heart failure with pulmonary hypertension. This device and therapy is still investigational, which means it is currently not approved by a regulatory agency (such as U.S Food and Drug Administration) for regular hospital use and it includes only individuals who choose to take part. Risks in this study include those for standard cardiac catheterization techniques and the administration of anesthesia including allergic reactions, low blood pressure, skin rash, or difficulty breathing; however, all of the risks may not be known. The study will last approximately 3 years and includes the following visits: Baseline/Screening, Procedure, Discharge, 1 month, 6 months and visits annually for 3 years. Study related procedures include a physical exam, blood testing, 6 minute walk test, echocardiogram, CT scan and a Right heart catheterization.
The purpose of this research study is to continue to test how well the Endospan NEXUSTM Aortic Arch Stent Graft System performs in the treatment of a diseased aortic arch. The aortic arch is the top part of the main large vessel that carries blood away from the heart. A stent graft is a self-expanding frame that is covered with a material intended to seal the vessel walls.
The NEXUS Aortic Arch Stent Graft System is delivered to the diseased area of your aorta by traveling through your vascular system using fluoroscopic guidance (x-ray pictures), starting with a small incision or needle puncture near your groin (inner thigh). The NEXUS Aortic Arch Stent Graft System is being studied and is not approved by the FDA which means it is investigational in this study. The NEXUS Aortic Arch Stent Graft System has CE Mark which means it is approved for use in Europe. The NEXUS Aortic Arch Stent Graft System is only available through the clinical study in the United States.
The PHAR is a multicenter, prospective registry of newly evaluated patients at PHCCs in the United States who have either PAH or CTEPH. Baseline information will be collected at the time of initial evaluation at the PHCC (within six months of the initial outpatient PHCC visit) with follow-up data collected at approximately 6-month intervals. This study will determine how patients with PH are evaluated, tested, and treated, and will observe how well patients do. The goal of the project is to see if patients with PH are treated according to recommended guidelines and to see if there are certain factors which lead to better or worse outcomes in patients with PH. There is no intervention or study medication used and there is no limitation to how a patient is treated in this study.