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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational | Device | We are collecting information for both retrospective and prospective arm to further understand the utility of PA pressure sensors. |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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All patients who have been or will be implanted with PA pressure sensor.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kartik Munshi, MPH | Contact | 913-945-6445 | kmunshi@kumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Hirak Shah, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Health | Recruiting | La Jolla | California | 92037 | United States |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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| 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 |
| Indiana University | Recruiting | Bloomington | Indiana | 47401 | United States |
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| University of Kansas Medical Center | Recruiting | Kansas City | Kansas | 66160 | United States |
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| Fairview Health | Not yet recruiting | Maplewood | Minnesota | 55109 | United States |
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| Minneapolis Heart Institute Foundation/ Allina Health | Recruiting | Minneapolis | Minnesota | 55407 | United States |
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| Saint Luke's Health System | Recruiting | Kansas City | Missouri | 64131 | United States |
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| University of North Carolina/ Rex Hospital, Inc. | Recruiting | Raleigh | North Carolina | 27607 | United States |
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| Providence Heart Institute | Recruiting | Portland | Oregon | 97225 | United States |
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| Prisma Health | Recruiting | Columbia | South Carolina | 29203 | United States |
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| Sanford Health | Recruiting | Sioux Falls | South Dakota | 57104 | United States |
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| Austin Heart | Recruiting | Austin | Texas | 78756 | United States |
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| Houston Methodist DeBakey Heart and Vascular Center | Recruiting | Houston | Texas | 77030 | United States |
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