NCT06425848

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Oct 2022

Longer than P75 for all trials

Geographic Reach
1 country

12 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
Oct 2022Dec 2030

Study Start

First participant enrolled

October 21, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 29, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 22, 2024

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

May 22, 2024

Status Verified

May 1, 2024

Enrollment Period

8.2 years

First QC Date

February 29, 2024

Last Update Submit

May 21, 2024

Conditions

Heart Failure

Keywords

Pulmonary Artery (PA) pressure monitor

Outcome Measures

Primary Outcomes (8)

  • 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

Study Arms (2)

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

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

Interventions

ObservationalDEVICE

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

Prospective armRetrospective arm

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Scripps Health

La Jolla, California, 92037, United States

RECRUITING

Indiana University

Bloomington, Indiana, 47401, United States

RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

Fairview Health

Maplewood, Minnesota, 55109, United States

NOT YET RECRUITING

Minneapolis Heart Institute Foundation/ Allina Health

Minneapolis, Minnesota, 55407, United States

RECRUITING

Saint Luke's Health System

Kansas City, Missouri, 64131, United States

RECRUITING

University of North Carolina/ Rex Hospital, Inc.

Raleigh, North Carolina, 27607, United States

RECRUITING

Providence Heart Institute

Portland, Oregon, 97225, United States

RECRUITING

Prisma Health

Columbia, South Carolina, 29203, United States

RECRUITING

Sanford Health

Sioux Falls, South Dakota, 57104, United States

RECRUITING

Austin Heart

Austin, Texas, 78756, United States

RECRUITING

Houston Methodist DeBakey Heart and Vascular Center

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Observation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Hirak Shah, MD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kartik Munshi, MPH

CONTACT

913-945-6445kmunshi@kumc.edu

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 29, 2024

First Posted

May 22, 2024

Study Start

October 21, 2022

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

May 22, 2024

Record last verified: 2024-05

Locations

US(12)