HF2 Registry - Hemodynamic Frontiers in Heart Failure Registry

Part of paid clinical trials in La Jolla, California.

Sponsor
University of Kansas Medical Center
Study ID
NCT06425848
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 21, 2022
Status verified
May 2024
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
2,000 participants (estimated)

Arms

  • Arm: Retrospective arm
    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).
  • Arm: Prospective arm
    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.

Primary Outcome Measure

Change in hemodynamics [ Time Frame: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant. ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
Scripps HealthLa JollaCalifornia92037
Timothy Jordan, MD
Thomas Heywood, MD (PRINCIPAL_INVESTIGATOR)
Indiana UniversityBloomingtonIndiana47401
Maya Guglin, MD
Maya Guglin, MD (PRINCIPAL_INVESTIGATOR)
University of Kansas Medical CenterKansas CityKansas66160
Kartik Munshi, MPH
[email protected]
Hirak Shah, MD (PRINCIPAL_INVESTIGATOR)
Fairview HealthMaplewoodMinnesota55109
Terrie-Ann Benjamin, MD
Terrie-Ann Benjamin, MD (PRINCIPAL_INVESTIGATOR)
Minneapolis Heart Institute Foundation/ Allina HealthMinneapolisMinnesota55407
Sarah Schwager, RN
Mosi Bennett, MD (PRINCIPAL_INVESTIGATOR)
Saint Luke's Health SystemKansas CityMissouri64131
Timothy Fendler, MD
Timothy Fendler, MD (PRINCIPAL_INVESTIGATOR)
University of North Carolina/ Rex Hospital, Inc.RaleighNorth Carolina27607
Elizabeth Volz, MD
Elizabeth Volz, MS (PRINCIPAL_INVESTIGATOR)
Providence Heart InstitutePortlandOregon97225
Christy Lenhart, RN
Jacob Abraham, MD (PRINCIPAL_INVESTIGATOR)
Prisma HealthColumbiaSouth Carolina29203
Suzanne Amaker
Patrick McCann, MD (PRINCIPAL_INVESTIGATOR)
Sanford HealthSioux FallsSouth Dakota57104
Orvaar Jonsson, MD
Orvaar Jonsson, MD (PRINCIPAL_INVESTIGATOR)
Austin HeartAustinTexas78756
Kunjan Bhatt, MS
Kunjan Bhatt, MD (PRINCIPAL_INVESTIGATOR)
Houston Methodist DeBakey Heart and Vascular CenterHoustonTexas77030
Saba Khan
Ashrith Guha, MD (PRINCIPAL_INVESTIGATOR)
Arvind Bhimaraj, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in La Jolla, CA

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Scripps Health· La Jolla, CAIndiana University· Bloomington, INUniversity of Kansas Medical Center· Kansas City, KSFairview Health· Maplewood, MNMinneapolis Heart Institute Foundation/ Allina Health· Minneapolis, MNSaint Luke's Health System· Kansas City, MO

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