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Recruiting NCT06425848

HF2 Registry - Hemodynamic Frontiers in Heart Failure Registry

— Observational Heart Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Observational.
Who it may be relevant to
Registry conditions: Heart Failure. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Hemodynamic Frontiers in Heart Failure Registry

Overview

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.

Interventions

  • Device Observational
    We are collecting information for both retrospective and prospective arm to further understand the utility of PA pressure sensors.

Primary outcome measures

  • Change in hemodynamics [Time frame: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant.]
  • Changes in Echocardiogram (ECHO) [Time frame: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant]
  • Medication changes [Time frame: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant]
  • Sodium [Time frame: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant]
  • Potassium [Time frame: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant]
  • Hemoglobin [Time frame: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant]
  • B-type natriuretic peptide (BNP) [Time frame: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant]
  • aminoterminal pro B-type natriuretic peptide (NT-proBNP) [Time frame: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant]

Eligibility criteria

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

United States · 12 centers
  • Scripps Health — La Jolla
  • Indiana University — Bloomington
  • University of Kansas Medical Center — Kansas City
  • Fairview Health — Maplewood
  • Minneapolis Heart Institute Foundation/ Allina Health — Minneapolis
  • Saint Luke's Health System — Kansas City
  • University of North Carolina/ Rex Hospital, Inc. — Raleigh
  • Providence Heart Institute — Portland
  • … and 4 more centers

Identifiers

NCT: NCT06425848 · STUDY00147383

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗