Right Heart Catheterization for Pulmonary Hypertension Detection

(PHINDER Trial)

Recruiting at 43 trial locations

Overseen By United Therapeutics Global Medical Information

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: United Therapeutics

Must not be taking: PAH medications

Disqualifiers: COPD, Sleep apnea, Pulmonary embolism, Ischemic heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to find better ways to detect pulmonary hypertension early in individuals with interstitial lung disease. Participants will undergo a right heart catheterization, which checks the pressure in the heart and lungs. The study is open to those diagnosed with interstitial lung disease who experience at least two signs or symptoms suggesting pulmonary hypertension, such as shortness of breath or fatigue. Joining this trial could help doctors develop more effective screening methods for these conditions. As an unphased trial, it offers participants the opportunity to contribute to groundbreaking research that could lead to earlier detection and better management of pulmonary hypertension.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently on FDA-approved pulmonary arterial hypertension medication.

What prior data suggests that right heart catheterization is safe for screening pulmonary hypertension in patients with interstitial lung disease?

Research has shown that right heart catheterization (RHC) is generally safe, with a very low risk of serious problems. A large study found the chance of a fatal event during the procedure to be just 0.055%. This means that out of every 1,000 people who undergo the test, fewer than one might experience a life-threatening issue.

The procedure measures pressure in the heart and lungs, and while complications can occur, they are uncommon. The most frequent risks include minor issues like bruising or bleeding at the catheter insertion site. Serious complications, such as heart rhythm problems or injury to blood vessels, are very rare.

Overall, RHC is well-tolerated and considered safe for most patients. Those considering participation in a study involving RHC can be assured of the procedure's strong safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on using right heart catheterization (RHC) for earlier detection of pulmonary hypertension in patients with interstitial lung disease. Unlike standard diagnostic methods like echocardiography, which provide indirect measurements, RHC offers direct and precise assessment of the heart and pulmonary arteries. This method can potentially identify pulmonary hypertension at an earlier stage, allowing for timely interventions and better management of the condition. By improving early detection, RHC could lead to better patient outcomes and transform the way pulmonary hypertension is diagnosed in interstitial lung disease patients.

What evidence suggests that right heart catheterization is effective for screening pulmonary hypertension in interstitial lung disease?

Research has shown that right heart catheterization (RHC) effectively checks heart pressures and assesses heart function. This procedure has been linked to improved patient outcomes, such as fewer hospital visits and reduced mortality rates. RHC is often used for conditions like severe heart failure, and its ability to directly measure heart function aids in identifying issues like pulmonary hypertension. These findings suggest that RHC plays a crucial role in diagnosing and managing heart-related conditions effectively.

In this trial, all patients enrolled in the single experimental study arm will undergo RHC to further evaluate its effectiveness in clinical settings. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

Inclusion Criteria

Patient gives voluntary written informed consent to participate in the study.

Idiopathic interstitial pneumonia, including idiopathic pulmonary fibrosis

Connective tissue disease-associated ILD with forced vital capacity (FVC) <70%

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Study Visit 1

Participants undergo clinical assessments including PFTs, HRCT, physical examination, 6-Minute Walk Test, blood draw, echocardiography, and questionnaires

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after assessments

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Right heart catheterization (RHC)

How Is the Trial Designed?

Group I: Experimental study arm Experimental Treatment 1 Intervention

All enrolled patients in this single arm study will receive a RHC.

Who Is Running the Clinical Trial?

United Therapeutics

Lead Sponsor

Trials

112

Recruited

14,500+

Dr. Martine Rothblatt

United Therapeutics

Chief Executive Officer since 1996

PhD in Medical Ethics from the Royal London College of Medicine and Dentistry, JD and MBA from UCLA

Dr. Michael Benkowitz

United Therapeutics

Chief Medical Officer since 2023

MD from Harvard Medical School

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/8782638/

The effectiveness of right heart catheterization in the initial ... ... RHC was associated with improved outcomes. Patients with higher baseline probability of surviving 2 months had the highest relative risk of death following RHC.

2. ahajournals.org ahajournals.org/doi/10.1161/JAHA.120.019843

Right Heart Catheterization in Cardiogenic Shock Is ... Thirty‐day readmission rates (18.7% versus 19.7%, P=0.04) and death on readmission (7.9% versus 9.3%, P=0.03) were also lower in the RHC group.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666084923002760

The Value of Right Heart Catheterization: Case Series ... Right heart catheterization (RHC) is an invasive procedure that allows for the direct measurement of intracardiac pressures and cardiac output.

4. jacc.org jacc.org/doi/10.1016/j.jchf.2024.03.020

Practical Guidance for Hemodynamic Assessment by Right ... More data are needed to demonstrate benefit of right heart catheterization in heart failure, in both improving survival and preventing rehospitalizations ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10352814/

Right heart catheterization in clinical practice: a review of ... This study indicates that patients with cardiogenic shock who undergo right heart catheterization have improved outcomes.

6. ahajournals.org ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.119.007791

Safety and Risk of Major Complications With Diagnostic ... Cardiogenic and septic shock, cardiac arrhythmia, and postsurgical complication were the most common causes of in-hospital death after LHC.

7. journal.chestnet.org journal.chestnet.org/article/S0012-3692(23)04884-5/fulltext

KEEPING THE RIGHT HEART IN MIND: SAFETY PROFILE OF ... RESULTS: A total of 317 cases fulfilled the inclusion criteria. Most patients were female (53.7%), with a mean age of 63.8 years. The main ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0735109706023382

Complications of Right Heart Catheterization Procedures in ... Four fatal events were recorded in association with any of the catheter procedures, resulting in an overall procedure-related mortality of 0.055% (95% ...

9. publications.ersnet.org publications.ersnet.org/content/errev/24/138/642

Right heart catheterisation: best practice and pitfalls in ... In summary, errors in measurement and data interpretation potentially encountered during RHC can increase the likelihood of misdiagnosis and complications.