HF2 Registry - Hemodynamic Frontiers in Heart Failure Registry

Last updated: May 21, 2024
Sponsor: University of Kansas Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Failure

Chest Pain

Congestive Heart Failure

Treatment

Observational

Clinical Study ID

NCT06425848
STUDY00147383
  • Ages 18-100
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. All patients would have been or will be implanted per indications from FDAapproval/CHAMPION trial. These would be patients with NYHA (New York HeartAssociation) Class III heart failure who had a prior hospitalization.

  2. Patients who meet the expanded FDA indication (BNP elevation without hospitalizationor NYHA class II).

Exclusion

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

Total Participants: 2000
Treatment Group(s): 1
Primary Treatment: Observational
Phase:
Study Start date:
October 21, 2022
Estimated Completion Date:
December 31, 2030

Study 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.

Connect with a study center

  • Scripps Health

    La Jolla, California 92037
    United States

    Active - Recruiting

  • Indiana University

    Bloomington, Indiana 47401
    United States

    Active - Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Fairview Health

    Maplewood, Minnesota 55109
    United States

    Site Not Available

  • Minneapolis Heart Institute Foundation/ Allina Health

    Minneapolis, Minnesota 55407
    United States

    Active - Recruiting

  • Saint Luke's Health System

    Kansas City, Missouri 64131
    United States

    Active - Recruiting

  • University of North Carolina/ Rex Hospital, Inc.

    Raleigh, North Carolina 27607
    United States

    Active - Recruiting

  • Providence Heart Institute

    Portland, Oregon 97225
    United States

    Active - Recruiting

  • Prisma Health

    Columbia, South Carolina 29203
    United States

    Active - Recruiting

  • Sanford Health

    Sioux Falls, South Dakota 57104
    United States

    Active - Recruiting

  • Austin Heart

    Austin, Texas 78756
    United States

    Active - Recruiting

  • Houston Methodist DeBakey Heart and Vascular Center

    Houston, Texas 77030
    United States

    Active - Recruiting

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