Clinical trial NCT06425848: HF2 Registry - Hemodynamic Frontiers in Heart Failure Registry
Official title: Hemodynamic Frontiers in Heart Failure Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Keywords: Pulmonary Artery (PA) pressure monitor
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2024-05-22
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who have been or will be implanted with PA pressure sensor.

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.

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.

Primary outcomes:
measure: Change in hemodynamics
timeFrame: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant.
measure: Changes in Echocardiogram (ECHO)
timeFrame: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant
measure: Medication changes
timeFrame: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant
measure: Sodium
timeFrame: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant
measure: Potassium
timeFrame: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant
measure: Hemoglobin
timeFrame: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant
measure: B-type natriuretic peptide (BNP)
timeFrame: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant
measure: aminoterminal pro B-type natriuretic peptide (NT-proBNP)
timeFrame: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Health
state: California
city: Bloomington
country: United States
facility: Indiana University
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Maplewood
country: United States
facility: Fairview Health
state: Minnesota
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation/ Allina Health
state: Minnesota
city: Kansas City
country: United States
facility: Saint Luke's Health System
state: Missouri
city: Raleigh
country: United States
facility: University of North Carolina/ Rex Hospital, Inc.
state: North Carolina
city: Portland
country: United States
facility: Providence Heart Institute
state: Oregon
city: Columbia
country: United States
facility: Prisma Health
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford Health
state: South Dakota
city: Austin
country: United States
facility: Austin Heart
state: Texas
city: Houston
country: United States
facility: Houston Methodist DeBakey Heart and Vascular Center
state: Texas
Study officials:
affiliation: University of Kansas Medical Center
name: Hirak Shah, MD
role: PRINCIPAL_INVESTIGATOR
References: