HF2 Registry - Hemodynamic Frontiers in Heart Failure Registry

University of Kansas Medical Center2,000 enrolled

Overview

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.

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

2,000

Conditions

Heart Failure

Interventions

ObservationalDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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.

Locations (12)

Scripps Health

La Jolla, California, United States

RECRUITING

Indiana University

Bloomington, Indiana, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Central Contacts

Kartik Munshi, MPH

CONTACT

913-945-6445 kmunshi@kumc.edu

Data from ClinicalTrials.gov

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