Registry for patients with heart failure using pulmonary artery pressure monitors
Hemodynamic Frontiers in Heart Failure Registry
This study is collecting information from patients with heart failure who have special sensors in their lungs to help improve treatment and understanding of their condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University of Kansas Medical Center Academic / other |
| Locations | 12 sites (La Jolla, California and 11 other locations) |
| Trial ID | NCT06425848 on ClinicalTrials.gov |
What this trial studies
The HF2 Registry aims to collect comprehensive data on patients with heart failure who have been implanted with pulmonary artery pressure sensors. This observational, multi-center registry will gather demographic, clinical, laboratory, and hemodynamic information to enhance understanding of ambulatory hemodynamics monitoring and heart failure therapies. Patients will be recruited from heart failure clinics and will have the option to consent to participate in the registry, which will also facilitate future research opportunities based on the collected data.
Who should consider this trial
Good fit: Ideal candidates include adults with NYHA Class III heart failure who have had prior hospitalizations or those meeting expanded FDA indications.
Not a fit: Patients under 18 years of age, pregnant women, or those unable to maintain continuity of care in a heart failure clinic may not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could lead to improved heart failure management and therapies through better understanding of patient data.
How similar studies have performed: Other studies utilizing similar observational approaches have shown promise in advancing heart failure management, indicating potential for success in this registry.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. All patients would have been or will be implanted per indications from FDA approval/CHAMPION trial. These would be patients with NYHA (New York Heart Association) Class III heart failure who had a prior hospitalization. 2. Patients who meet the expanded FDA indication (BNP elevation without hospitalization or NYHA class II). Exclusion Criteria: 1. Patients less than 18 years of age. 2. Pregnant women at the scheduled time of PA pressure sensor implant. 3. Patients unable or unwilling to have continuity of care in the heart failure clinic.
Where this trial is running
La Jolla, California and 11 other locations
- Scripps Health — La Jolla, California, United States (Recruiting)
- Indiana University — Bloomington, Indiana, United States (Recruiting)
- University of Kansas Medical Center — Kansas City, Kansas, United States (Recruiting)
- Fairview Health — Maplewood, Minnesota, United States (Not_yet_recruiting)
- Minneapolis Heart Institute Foundation/ Allina Health — Minneapolis, Minnesota, United States (Recruiting)
- Saint Luke's Health System — Kansas City, Missouri, United States (Recruiting)
- University of North Carolina/ Rex Hospital, Inc. — Raleigh, North Carolina, United States (Recruiting)
- Providence Heart Institute — Portland, Oregon, United States (Recruiting)
- Prisma Health — Columbia, South Carolina, United States (Recruiting)
- Sanford Health — Sioux Falls, South Dakota, United States (Recruiting)
- Austin Heart — Austin, Texas, United States (Recruiting)
- Houston Methodist DeBakey Heart and Vascular Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Hirak Shah, MD — University of Kansas Medical Center
- Study coordinator: Kartik Munshi, MPH
- Email: kmunshi@kumc.edu
- Phone: 913-945-6445
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.