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HF2 Registry - Hemodynamic Frontiers in Heart Failure Registry
NCT06425848 · University of Kansas Medical Center
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Hemodynamic Frontiers in Heart Failure Registry
About this study
Longitudinal, multi-center, and non-interventional registry. Patients will be identified as eligible for pulmonary artery pressure sensor implant by a heart failure cardiologist from the heart failure clinic. They will consent for device implant and procedure (right heart catheterization) per standard of care. Patients may also consent to the registry participation, which is optional. They will be informed that the registry intends to gather data and that they may be approached in the future for additional research based on their data and clinical situation. Additionally, patients who underwent pulmonary artery pressure sensor implantation from January 1, 2019, will be identified and consent will be obtained for registry participation, which is optional.
Eligibility 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.
Study design
Enrollment target: 2000 participants
Age groups: adult, older_adult
Timeline
Starts: 2022-10-21
Estimated completion: 2030-12-31
Last updated: 2024-05-22
Interventions
Device: Observational
Primary outcomes
- • Change in hemodynamics (at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant.)
- • Changes in Echocardiogram (ECHO) (at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant)
- • Medication changes (at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant)
Sponsor
University of Kansas Medical Center · other
Contacts & investigators
ContactKartik Munshi, MPH · contact · kmunshi@kumc.edu · 913-945-6445
InvestigatorHirak Shah, MD · principal_investigator, University of Kansas Medical Center
All locations (12)
Scripps HealthRecruiting
La Jolla, California, United States
Indiana UniversityRecruiting
Bloomington, Indiana, United States
University of Kansas Medical CenterRecruiting
Kansas City, Kansas, United States
Fairview HealthNot Yet Recruiting
Maplewood, Minnesota, United States
Minneapolis Heart Institute Foundation/ Allina HealthRecruiting
Minneapolis, Minnesota, United States
Saint Luke's Health SystemRecruiting
Kansas City, Missouri, United States
University of North Carolina/ Rex Hospital, Inc.Recruiting
Raleigh, North Carolina, United States
Providence Heart InstituteRecruiting
Portland, Oregon, United States
Prisma HealthRecruiting
Columbia, South Carolina, United States
Sanford HealthRecruiting
Sioux Falls, South Dakota, United States
Austin HeartRecruiting
Austin, Texas, United States
Houston Methodist DeBakey Heart and Vascular CenterRecruiting
Houston, Texas, United States