HF2 Registry - Hemodynamic Frontiers in Heart Failure Registry
- Conditions
- Heart Failure
- Interventions
- Device: Observational
- Registration Number
- NCT06425848
- Lead Sponsor
- University of Kansas Medical Center
- Brief Summary
The purpose of the HF2 (Hemodynamic Frontiers in Heart Failure) registry is to collect relevant patient-level demographic, clinical, laboratory, and hemodynamic data from patients implanted with pulmonary artery pressure sensor at participating centers to advance scientific knowledge about ambulatory hemodynamics monitoring and HF (Heart Failure) therapies. The data collected will be used for retrospective studies, quality improvement, identifying research cohorts, and member-initiated research.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2000
- 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.
- Patients who meet the expanded FDA indication (BNP elevation without hospitalization or NYHA class II).
- Patients less than 18 years of age.
- Pregnant women at the scheduled time of PA pressure sensor implant.
- Patients unable or unwilling to have continuity of care in the heart failure clinic.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Prospective arm Observational 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. Retrospective arm Observational 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).
- Primary Outcome Measures
Name Time Method Potassium at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant Potassium level, reported as milliequivalents per liter (mEq/L), will be collected at implant and 3 months, 6 months, 12 months, 24 months and 36 months post implant.
Hemoglobin at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant Hemoglobin concentration (Hb) reported as grams of hemoglobin per deciliter of blood (g/dL). Labs will be collected at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant
B-type natriuretic peptide (BNP) at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant BNP level, reported as 100 picograms per milliliter (pg/mL), will be collected at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant
aminoterminal pro B-type natriuretic peptide (NT-proBNP) at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant NT-proBNP level, reported as 100 picograms per milliliter (pg/mL), will be collected at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant
Change in hemodynamics at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant. Hemodynamic data such as mean PA pressure in mmHg, PA systolic pressure in mmHg, PA diastolic pressures in mmHg, will be collected at the time of implant of PA pressure sensor and at 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 Echo data such as Left Ventricular Ejection Fraction (LVEF) percentage will be collected at implant and at 3 months, 6 months, 12 months, 24 months and 36 months if available.
Medication changes at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant Medications changes such as type of diuretics, will be collected after implant and at 3 months, 6 months, 12 month, 24 months and 36 months. We are not collecting any doses or frequencies.
Sodium at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant Sodium levels, reported as millimoles per liter (mmol/L), will be collected at implant and 3 months, 6 months, 12 months, 24 months and 36 months post implant.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
Minneapolis Heart Institute Foundation/ Allina Health
🇺🇸Minneapolis, Minnesota, United States
Houston Methodist DeBakey Heart and Vascular Center
🇺🇸Houston, Texas, United States
Indiana University
🇺🇸Bloomington, Indiana, United States
Scripps Health
🇺🇸La Jolla, California, United States
University of North Carolina/ Rex Hospital, Inc.
🇺🇸Raleigh, North Carolina, United States
Fairview Health
🇺🇸Maplewood, Minnesota, United States
Sanford Health
🇺🇸Sioux Falls, South Dakota, United States
Providence Heart Institute
🇺🇸Portland, Oregon, United States
Prisma Health
🇺🇸Columbia, South Carolina, United States
Saint Luke's Health System
🇺🇸Kansas City, Missouri, United States
Austin Heart
🇺🇸Austin, Texas, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States