HF2 Registry - Hemodynamic Frontiers in Heart Failure Registry

Официальное название

Hemodynamic Frontiers in Heart Failure Registry

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Change in hemodynamics [Срок оценки: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant.]
• Changes in Echocardiogram (ECHO) [Срок оценки: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant]
• Medication changes [Срок оценки: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant]
• Sodium [Срок оценки: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant]
• Potassium [Срок оценки: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant]
• Hemoglobin [Срок оценки: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant]
• B-type natriuretic peptide (BNP) [Срок оценки: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant]
• aminoterminal pro B-type natriuretic peptide (NT-proBNP) [Срок оценки: at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

США · 12 центров

• Scripps Health — La Jolla
• Indiana University — Bloomington
• University of Kansas Medical Center — Kansas City
• Fairview Health — Maplewood
• Minneapolis Heart Institute Foundation/ Allina Health — Minneapolis
• Saint Luke's Health System — Kansas City
• University of North Carolina/ Rex Hospital, Inc. — Raleigh
• Providence Heart Institute — Portland
• … и ещё 4 центра

Идентификаторы

NCT: NCT06425848 · STUDY00147383

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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