HF2 Registry - Hemodynamic Frontiers in Heart Failure Registry

Heart Failure Clinical Trial

— HF2 Registry  

Official title:

Hemodynamic Frontiers in Heart Failure Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06425848
• Other study ID #: STUDY00147383
• Status: Recruiting
• Start date: October 21, 2022
• Est. completion date: December 31, 2030

Study information

• Verified date: May 2024
• Source: University of Kansas Medical Center
• Contact: Kartik Munshi, MPH
• Phone: 913-945-6445
• Email: kmunshi[@]kumc.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
United States	Austin Heart	Austin	Texas
United States	Indiana University	Bloomington	Indiana
United States	Prisma Health	Columbia	South Carolina
United States	Houston Methodist DeBakey Heart and Vascular Center	Houston	Texas
United States	Saint Luke's Health System	Kansas City	Missouri
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Scripps Health	La Jolla	California
United States	Fairview Health	Maplewood	Minnesota
United States	Minneapolis Heart Institute Foundation/ Allina Health	Minneapolis	Minnesota
United States	Providence Heart Institute	Portland	Oregon
United States	University of North Carolina/ Rex Hospital, Inc.	Raleigh	North Carolina
United States	Sanford Health	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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