Observational Study for Heart Failure

(HF2 Registry Trial)

Recruiting at 11 trial locations

Overseen By Kartik Munshi, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Disqualifiers: Under 18, Pregnant, others

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

Compensation: Varies

Number of Visits: 1

2000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to better understand heart failure by collecting data from patients using special sensors in their pulmonary arteries. These sensors monitor heart-related pressure changes, offering insights into heart failure treatments. The trial consists of two parts: one for patients who already have the sensors and another for new patients receiving them. Suitable candidates include those with heart failure who have experienced a past hospitalization or symptoms like shortness of breath during regular activities. As an unphased trial, this study allows patients to contribute to groundbreaking research that could enhance heart failure treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the pulmonary artery pressure sensor is safe for heart failure patients?

Research has shown that using a sensor to monitor blood pressure in the lungs is generally safe for people with heart failure. Studies have found that tracking this pressure can reduce hospital visits and improve overall health. One study found that patients could perform daily activities more easily when using these sensors.

The Cordella Pulmonary Artery Sensor System, a specific device for this purpose, has undergone safety evaluations. Previous studies support its safety and effectiveness in managing heart failure. Although no treatment is without risks, research suggests that these sensors are well-tolerated and can offer significant health benefits for those with heart failure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new frontier in managing heart failure by using pulmonary artery (PA) pressure sensors. Unlike traditional treatments, which often rely on medications to manage symptoms, this approach provides real-time data on heart health, potentially allowing for more precise and timely interventions. By monitoring PA pressure, doctors can adjust treatments more effectively, potentially reducing hospitalizations and improving patient outcomes. The trial aims to assess whether this approach can lead to better management of heart failure, offering a more personalized and proactive care strategy.

What evidence suggests that the pulmonary artery pressure sensor is effective for heart failure?

This trial includes two arms studying the use of a pulmonary artery pressure sensor. Studies have shown that monitoring pressure in the pulmonary artery with a sensor can significantly reduce hospital visits for people with heart failure. In one study, patients with these sensors experienced fewer hospital stays, with only 0.41 events per patient-year, compared to a higher rate in those without the sensor. Another study found that these devices can lower both the risk of death and the severity of the disease. Additionally, monitoring blood flow through these sensors helped reduce pressure in the pulmonary artery, benefiting heart failure patients. Overall, this technology shows promise in improving outcomes for those living with heart failure. ^{2 6 7 8 9}

Who Is on the Research Team?

Hirak Shah, MD

Principal Investigator

University of Kansas Medical Center

Are You a Good Fit for This Trial?

Inclusion Criteria

I have Class III heart failure and was hospitalized for it before.

I have heart failure symptoms without needing hospitalization.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation

Patients undergo pulmonary artery pressure sensor implant and right heart catheterization as per standard of care

1 day

1 visit (in-person)

Data Collection

Hemodynamic, BNP, hemoglobin, potassium, ECHO, NT-proBNP, and sodium data are collected at implant and at 3, 6, 12, 24, and 36 months post-implant

36 months

Multiple visits (in-person) at specified intervals

Follow-up

Participants are monitored for safety and effectiveness after data collection

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Pulmonary Artery Pressure Sensor

How Is the Trial Designed?

Group I: Retrospective arm Experimental Treatment 1 Intervention

Patients who underwent PA pressure implantation from January 1, 2019 will be identified for registry participation. Patients who were implanted before November 8, 2022 will be considered enrolled in the retrospective arm of the registry and may not need to consent if consent waiver is granted by the institutional IRB (Institutional Review Board).

Group II: Prospective arm Experimental Treatment 1 Intervention

Patients will be identified as eligible for PA pressure sensor implant by a heart failure cardiologist. Patients will consent for device implant and procedure (right heart catheterization) as per standard of care. Patients may also consent to registry participation as per local institutional guidelines and requirements.

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10542655/

Efficacy of pulmonary artery pressure monitoring in patients ... Heart failure hospitalizations occurred 473 times among 943 patients in the PA pressure monitoring group (0.41 events per patient-year) and 699 times among 955 ...

2. nature.com nature.com/articles/s41598-024-63742-0

Effectiveness of remote pulmonary artery pressure ... This meta-analysis examines the efficacy of PAP monitoring devices (CardioMEMS and Chronicle) in preventing adverse outcomes in HF patients.

3. ahajournals.org ahajournals.org/doi/10.1161/CIRCHEARTFAILURE.124.012754

Relationship Between Remote, Ambulatory Pulmonary ... Using a remote, ambulatory pulmonary artery (PA) pressure monitor, has been shown to reduce mortality and morbidity.

4. jacc.org jacc.org/doi/10.1016/j.jchf.2024.05.017

Results of the PROACTIVE-HF Trial | JACC: Heart Failure The primary and secondary safety and effectiveness endpoints of PROACTIVE-HF were exceeded. The safety profile was excellent with 99.2% freedom ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1875213624003097

Results from the CardioMEMS HF System Post-Market ... After 2 years of haemodynamic-guided care, systolic PA pressure was reduced, with an average pressure change versus baseline of –4.3 ± 8.43 mmHg (P < 0.0001); ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39152983/

Seated Pulmonary Artery Pressure Monitoring in Patients ... Conclusions: Remote management of seated mPAP is safe and results in a low rate of HF hospitalizations and mortality. These results support the ...

7. ahajournals.org ahajournals.org/doi/10.1161/CIRCHEARTFAILURE.122.009960

Use of a Pulmonary Artery Pressure Sensor to Manage ... Reductions of 3 to 5 mm Hg in mean PAP (PAM) were associated with improved functional capacity, reduced hospitalizations, and better overall ...

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/P230040B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The Cordella Pulmonary Artery Sensor System is intended to measure, record and transmit pulmonary artery pressure (PAP) data from NYHA Class III heart failure ...

9. cms.gov cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?ncaid=313&proposed=Y

NCA - Implantable Pulmonary Artery Pressure Sensors for ... Overall, mortality due to HF remains high at approximately 50% at 5 years (Roger 2021). Risk stratification models continue to evolve. A 2021 study suggested ...