HF2 Registry - Hemodynamic Frontiers in Heart Failure Registry (HF2 Registry)

Hemodynamic Frontiers in Heart Failure Registry

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Device: Observational

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.

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Kartik Munshi, MPH; Phone Number: 913-945-6445; Email: kmunshi@kumc.edu

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Recruiting
      • Scripps Health
      • Contact: Timothy Jordan, MD
      • Principal Investigator: Thomas Heywood, MD
  • Indiana
    • Bloomington, Indiana, United States, 47401
      • Recruiting
      • Indiana University
      • Principal Investigator: Maya Guglin, MD
      • Contact: Maya Guglin, MD
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas Medical Center
      • Principal Investigator: Hirak Shah, MD
      • Contact: Kartik Munshi, MPH; Email: kmunshi@kumc.edu
  • Minnesota
    • Maplewood, Minnesota, United States, 55109
      • Not yet recruiting
      • Fairview Health
      • Contact: Terrie-Ann Benjamin, MD
      • Principal Investigator: Terrie-Ann Benjamin, MD
    • Minneapolis, Minnesota, United States, 55407
      • Recruiting
      • Minneapolis Heart Institute Foundation/ Allina Health
      • Principal Investigator: Mosi Bennett, MD
      • Contact: Sarah Schwager, RN
  • Missouri
    • Kansas City, Missouri, United States, 64131
      • Recruiting
      • Saint Luke's Health System
      • Contact: Timothy Fendler, MD
      • Principal Investigator: Timothy Fendler, MD
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • Recruiting
      • University of North Carolina/ Rex Hospital, Inc.
      • Contact: Elizabeth Volz, MD
      • Principal Investigator: Elizabeth Volz, MS
  • Oregon
    • Portland, Oregon, United States, 97225
      • Recruiting
      • Providence Heart Institute
      • Principal Investigator: Jacob Abraham, MD
      • Contact: Christy Lenhart, RN
  • South Carolina
    • Columbia, South Carolina, United States, 29203
      • Recruiting
      • Prisma Health
      • Principal Investigator: Patrick McCann, MD
      • Contact: Suzanne Amaker
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57104
      • Recruiting
      • Sanford Health
      • Contact: Orvaar Jonsson, MD
      • Principal Investigator: Orvaar Jonsson, MD
  • Texas
    • Austin, Texas, United States, 78756
      • Recruiting
      • Austin Heart
      • Contact: Kunjan Bhatt, MS
      • Principal Investigator: Kunjan Bhatt, MD
    • Houston, Texas, United States, 77030
      • Recruiting
      • Houston Methodist DeBakey Heart and Vascular Center
      • Contact: Saba Khan
      • Principal Investigator: Ashrith Guha, MD
      • Principal Investigator: Arvind Bhimaraj, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients who have been or will be implanted with PA pressure sensor.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	Device: Observational; We are collecting information for both retrospective and prospective arm to further understand the utility of PA pressure sensors.
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.	Device: Observational; We are collecting information for both retrospective and prospective arm to further understand the utility of PA pressure sensors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in hemodynamics	Hemodynamic data such as mean PA pressure in mmHg, PA systolic pressure in mmHg, PA diastolic pressures in mmHg, will be collected at the time of implant of PA pressure sensor and at 3 months, 6 months, 12 months, 24 months and 36 months post implant.	at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant.
Changes in Echocardiogram (ECHO)	Echo data such as Left Ventricular Ejection Fraction (LVEF) percentage will be collected at implant and at 3 months, 6 months, 12 months, 24 months and 36 months if available.	at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant
Medication changes	Medications changes such as type of diuretics, will be collected after implant and at 3 months, 6 months, 12 month, 24 months and 36 months. We are not collecting any doses or frequencies.	at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant
Sodium	Sodium levels, reported as millimoles per liter (mmol/L), will be collected at implant and 3 months, 6 months, 12 months, 24 months and 36 months post implant.	at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant
Potassium	Potassium level, reported as milliequivalents per liter (mEq/L), will be collected at implant and 3 months, 6 months, 12 months, 24 months and 36 months post implant.	at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant
Hemoglobin	Hemoglobin concentration (Hb) reported as grams of hemoglobin per deciliter of blood (g/dL). Labs will be collected at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant	at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant
B-type natriuretic peptide (BNP)	BNP level, reported as 100 picograms per milliliter (pg/mL), will be collected at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant	at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant
aminoterminal pro B-type natriuretic peptide (NT-proBNP)	NT-proBNP level, reported as 100 picograms per milliliter (pg/mL), will be collected at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant	at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Investigators: Principal Investigator: Hirak Shah, MD, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2022
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: February 29, 2024
• First Submitted That Met QC Criteria: May 21, 2024
• First Posted (Actual): May 22, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2024
• Last Update Submitted That Met QC Criteria: May 21, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Pulmonary Artery (PA) pressure monitor
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: STUDY00147383

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No