A PHASE 2, OPEN-LABEL EXTENSION STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF PF-07868489 ADMINISTERED TO ADULT PARTICIPANTS WITH PULMONARY ARTERIAL HYPERTENSION

Date Added
June 18th, 2026
PRO Number
Pro00148603
Researcher
Rahul Argula

List of Studies


Keywords
Pulmonary Hypertension
Summary

The study is designed to give continued access to people with Pulmonary Arterial Hypertension (PAH) who were part of an earlier trial (Pfizer Pulmonary Arterial Hypertension [PAH] C5001001) of the medication PF-07868489. It also aims to see how safe the medication is over a longer period, how well people tolerate it, and whether it continues to work effectively for adults with Pulmonary Arterial Hypertension (PAH).

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

Enhancing Virtual Mindfulness Program to Improve Physical Activity in Adults With Pulmonary Hypertension: Usability Optimization, Feasibility Testing, and Implementation Strategy Development

Date Added
May 21st, 2026
PRO Number
Pro00150536
Researcher
Tania Von Visger

List of Studies

Keywords
Pulmonary Hypertension
Summary

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.

Institution
MUSC
Recruitment Contact
Tania Von Visger
614-822-6637
vonvisge@musc.edu

An Open-label Long-term Follow-up Study to Evaluate the Effects of Sotatercept when Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH (MK-7962-038)

Date Added
March 26th, 2026
PRO Number
Pro00150204
Researcher
Rahul Argula

List of Studies


Keywords
Pulmonary, Pulmonary Hypertension
Summary

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.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

MOMENTOUS study (iMpact Of an ecg ai ModEl oN The diagnosis Of pUlmonary hypertenSion)

Date Added
February 24th, 2026
PRO Number
Pro00148837
Researcher
Rachana Krishna

List of Studies


Keywords
Interstitial Lung Disease (ILD), Pulmonary Hypertension
Summary

The MOMENTOUS study will test the prospective performance of the Tempus Pulmonary Hypertension ECG model within patients with interstitial lung disease (ILD) who do not have a diagnosis of Pulmonary Hypertension. The purpose of the study is to provide information on the clinical utility of this new technology within a multicenter randomized study. The study will target approximately 1000 participants completing the study over a period of 2-3 years. Study participation will consist of 4 visits over a period of 6 months.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

A Prospective, Multi-Center, Open Label, Randomized Control Clinical Trial Evaluating the Safety and Efficacy of the Cordella Pulmonary Artery Sensor System in New York Heart Association (NYHA) Class II - III Heart Failure Patients

Date Added
November 12th, 2025
PRO Number
Pro00147296
Researcher
Vishal Rao

List of Studies

Keywords
Heart, Pulmonary Hypertension
Summary

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.

Institution
MUSC
Recruitment Contact
Shaquanda Goodwine
843-876-5783
shr37@musc.edu

A PHASE 1 / 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SINGLE ESCALATING DOSES OF PF-07868489 IN HEALTHY ADULT PARTICIPANTS AND, ADDITIONALLY, CLINICAL ACTIVITY OF REPEAT DOSES IN PARTICIPANTS WITH PULMONARY ARTERIAL HYPERTENSION

Date Added
August 28th, 2025
PRO Number
Pro00144472
Researcher
Rahul Argula

List of Studies


Keywords
Pulmonary Hypertension
Summary

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.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

A Real-world Patient Registry in Group 3 Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

Date Added
July 9th, 2025
PRO Number
Pro00144899
Researcher
Denise Gabrielle Sese

List of Studies

Keywords
Interstitial Lung Disease (ILD), Pulmonary Hypertension
Summary

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.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
(843) 792-0965
recruitment@musc.edu

A Phase 2, Multicenter, Double-blind, Extension Study to Evaluate the Effects of Sotatercept for the Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) due to Heart Failure with Preserved Ejection Fraction (HFpEF)

Date Added
May 27th, 2025
PRO Number
Pro00143751
Researcher
Daniel Silverman

List of Studies

Keywords
Cardiovascular, Pulmonary Hypertension
Summary

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.

Institution
MUSC
Recruitment Contact
Madison Johnson
843-792-4615
johme@musc.edu

A Phase 2, Randomized, Placebo-Controlled Trial to Assess the Efficacy and Safety of Mosliciguat in Participants with Pulmonary Hypertension Associated with Interstitial Lung Disease

Date Added
December 6th, 2024
PRO Number
Pro00140922
Researcher
Rahul Argula

List of Studies


Keywords
Interstitial Lung Disease (ILD), Pulmonary Hypertension
Summary

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.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

Pulmonary Artery Denervation Clinical Study using the Gradient Denervation System in Heart Failure Patients with Pulmonary Hypertension Group 2

Date Added
March 26th, 2024
PRO Number
Pro00135798
Researcher
Thomas Todoran

List of Studies


Keywords
Cardiovascular, Heart, Pulmonary Hypertension
Summary

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.

Institution
MUSC
Recruitment Contact
Anthony Awkar
843 876-5009
awkar@musc.edu



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