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NCT Number: NCT06425848

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.

Recruiting

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Scripps Health, La Jolla, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

observational

Device

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

Primary outcomes

  1. Change in hemodynamics

    Time frame: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant.

    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.

  2. Changes in Echocardiogram (ECHO)

    Time frame: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant

    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.

  3. Medication changes

    Time frame: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant

    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.

  4. Sodium

    Time frame: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant

    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.

  5. Potassium

    Time frame: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant

    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.

  6. Hemoglobin

    Time frame: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant

    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

  7. B-type natriuretic peptide (BNP)

    Time frame: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant

    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

  8. 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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Kartik Munshi, MPH

CONTACT

[email protected]

913-945-6445

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Official study title

Hemodynamic Frontiers in Heart Failure Registry

Acronym: HF2 Registry

Important dates

Study start
2022
Primary completion
2030
Study completion
2030
First posted
May 22, 2024
Registry last updated
May 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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