Recruiting

Observational Study

Sponsor:

University of Kansas Medical Center

Code:

NCT06425848

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Observational

Study Details

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.

Conditions

Heart Failure

Study ID

NCT06425848

Start date

Oct 21, 2022

Status verified date

May, 2024

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Arms

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).

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.

Interventions

Observational

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Kartik Munshi, MPH

913-945-6445kmunshi@kumc.edu

Locations

Scripps Health

Recruiting

La Jolla, California, United States, 92037

Principal Investigator:

Thomas Heywood, MD

Indiana University

Recruiting

Bloomington, Indiana, United States, 47401

Principal Investigator:

Maya Guglin, MD

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Kartik Munshi, MPH

kmunshi@kumc.edu

Principal Investigator:

Hirak Shah, MD

Minneapolis Heart Institute Foundation/ Allina Health

Recruiting

Minneapolis, Minnesota, United States, 55407

Principal Investigator:

Mosi Bennett, MD

Saint Luke's Health System

Recruiting

Kansas City, Missouri, United States, 64131

Principal Investigator:

Timothy Fendler, MD

University of North Carolina/ Rex Hospital, Inc.

Recruiting

Raleigh, North Carolina, United States, 27607

Principal Investigator:

Elizabeth Volz, MS

Providence Heart Institute

Recruiting

Portland, Oregon, United States, 97225

Principal Investigator:

Jacob Abraham, MD

Prisma Health

Recruiting

Columbia, South Carolina, United States, 29203

Principal Investigator:

Patrick McCann, MD

Sanford Health

Recruiting

Sioux Falls, South Dakota, United States, 57104

Principal Investigator:

Orvaar Jonsson, MD

Austin Heart

Recruiting

Austin, Texas, United States, 78756

Principal Investigator:

Kunjan Bhatt, MD

Houston Methodist DeBakey Heart and Vascular Center

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Ashrith Guha, MD

More Information

Sponsor

University of Kansas Medical Center

Last update posted

May 22, 2024

Last verified

May, 2024

Keywords

  • Pulmonary Artery (PA) pressure monitor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2024-05-22.