NORM-guided Congestion Management in Heart Failure Pivotal Study
HFSA ePoster Library. Jason G. 10/11/26; 4236985; CTC-019
Dr. Guichard Jason
REGULAR CONTENT
Login now to access Regular content available to all registered users.
Abstract
Discussion Forum (0)
Rate & Comment (0)
General ePoster - EP.6.B: On 2026-10-11 13:15 (Monitor 01)
Topic: Clinical Trial Central abstract
Carolyn Borme. Prisma Health, Millsap, TX
NORM-HF: A Pivotal Randomized Trial Evaluating Continuous Congestion Monitoring and Physician-Directed Patient Self-Management in Heart Failure Background: Heart failure (HF) decompensation is frequently preceded by worsening congestion, but intervention often occurs only after symptoms develop. The NORM System was designed to provide continuous physiologic assessment of congestion and support physician-directed patient self-management. Methods: NORM-HF is an international, multicenter, prospective, randomized PROBE trial enrolling approximately 800 patients with NYHA Class II-III HF at risk for decompensation across sites in the United States, United Kingdom, and Europe. Patients are randomized 1:1 to standard of care or the NORM System. The system consists of an implantable inferior vena cava (IVC) sensor that measures IVC area and collapsibility to generate the NORM Score, a physiologic congestion index. Data are transmitted wirelessly to a wearable belt worn once a day and cloud-based platform. Patients in the intervention arm receive their daily congestion zone and follow pre-specified physician-directed self-management plans, while physicians monitor trends, adherence, and adjust care plans as needed. Results: Enrollment is ongoing. Conclusion: The primary endpoint is a composite of cardiovascular death and worsening HF events defined as HF hospitalization, emergency department/urgent care HF events, or outpatient IV HF diuretic therapy for worsening HF. The event-driven trial will continue until 680 primary endpoint events have occurred and is powered at approximately 88% to detect a hazard ratio of 0.70. NORM-HF will evaluate whether continuous congestion monitoring coupled with physician-directed patient self-management can reduce HF events and improve clinical outcomes. ClinicalTrials.gov Identifier: NCT07574593.
Topic: Clinical Trial Central abstract
Carolyn Borme. Prisma Health, Millsap, TX
NORM-HF: A Pivotal Randomized Trial Evaluating Continuous Congestion Monitoring and Physician-Directed Patient Self-Management in Heart Failure Background: Heart failure (HF) decompensation is frequently preceded by worsening congestion, but intervention often occurs only after symptoms develop. The NORM System was designed to provide continuous physiologic assessment of congestion and support physician-directed patient self-management. Methods: NORM-HF is an international, multicenter, prospective, randomized PROBE trial enrolling approximately 800 patients with NYHA Class II-III HF at risk for decompensation across sites in the United States, United Kingdom, and Europe. Patients are randomized 1:1 to standard of care or the NORM System. The system consists of an implantable inferior vena cava (IVC) sensor that measures IVC area and collapsibility to generate the NORM Score, a physiologic congestion index. Data are transmitted wirelessly to a wearable belt worn once a day and cloud-based platform. Patients in the intervention arm receive their daily congestion zone and follow pre-specified physician-directed self-management plans, while physicians monitor trends, adherence, and adjust care plans as needed. Results: Enrollment is ongoing. Conclusion: The primary endpoint is a composite of cardiovascular death and worsening HF events defined as HF hospitalization, emergency department/urgent care HF events, or outpatient IV HF diuretic therapy for worsening HF. The event-driven trial will continue until 680 primary endpoint events have occurred and is powered at approximately 88% to detect a hazard ratio of 0.70. NORM-HF will evaluate whether continuous congestion monitoring coupled with physician-directed patient self-management can reduce HF events and improve clinical outcomes. ClinicalTrials.gov Identifier: NCT07574593.
General ePoster - EP.6.B: On 2026-10-11 13:15 (Monitor 01)
Topic: Clinical Trial Central abstract
Carolyn Borme. Prisma Health, Millsap, TX
NORM-HF: A Pivotal Randomized Trial Evaluating Continuous Congestion Monitoring and Physician-Directed Patient Self-Management in Heart Failure Background: Heart failure (HF) decompensation is frequently preceded by worsening congestion, but intervention often occurs only after symptoms develop. The NORM System was designed to provide continuous physiologic assessment of congestion and support physician-directed patient self-management. Methods: NORM-HF is an international, multicenter, prospective, randomized PROBE trial enrolling approximately 800 patients with NYHA Class II-III HF at risk for decompensation across sites in the United States, United Kingdom, and Europe. Patients are randomized 1:1 to standard of care or the NORM System. The system consists of an implantable inferior vena cava (IVC) sensor that measures IVC area and collapsibility to generate the NORM Score, a physiologic congestion index. Data are transmitted wirelessly to a wearable belt worn once a day and cloud-based platform. Patients in the intervention arm receive their daily congestion zone and follow pre-specified physician-directed self-management plans, while physicians monitor trends, adherence, and adjust care plans as needed. Results: Enrollment is ongoing. Conclusion: The primary endpoint is a composite of cardiovascular death and worsening HF events defined as HF hospitalization, emergency department/urgent care HF events, or outpatient IV HF diuretic therapy for worsening HF. The event-driven trial will continue until 680 primary endpoint events have occurred and is powered at approximately 88% to detect a hazard ratio of 0.70. NORM-HF will evaluate whether continuous congestion monitoring coupled with physician-directed patient self-management can reduce HF events and improve clinical outcomes. ClinicalTrials.gov Identifier: NCT07574593.
Topic: Clinical Trial Central abstract
Carolyn Borme. Prisma Health, Millsap, TX
NORM-HF: A Pivotal Randomized Trial Evaluating Continuous Congestion Monitoring and Physician-Directed Patient Self-Management in Heart Failure Background: Heart failure (HF) decompensation is frequently preceded by worsening congestion, but intervention often occurs only after symptoms develop. The NORM System was designed to provide continuous physiologic assessment of congestion and support physician-directed patient self-management. Methods: NORM-HF is an international, multicenter, prospective, randomized PROBE trial enrolling approximately 800 patients with NYHA Class II-III HF at risk for decompensation across sites in the United States, United Kingdom, and Europe. Patients are randomized 1:1 to standard of care or the NORM System. The system consists of an implantable inferior vena cava (IVC) sensor that measures IVC area and collapsibility to generate the NORM Score, a physiologic congestion index. Data are transmitted wirelessly to a wearable belt worn once a day and cloud-based platform. Patients in the intervention arm receive their daily congestion zone and follow pre-specified physician-directed self-management plans, while physicians monitor trends, adherence, and adjust care plans as needed. Results: Enrollment is ongoing. Conclusion: The primary endpoint is a composite of cardiovascular death and worsening HF events defined as HF hospitalization, emergency department/urgent care HF events, or outpatient IV HF diuretic therapy for worsening HF. The event-driven trial will continue until 680 primary endpoint events have occurred and is powered at approximately 88% to detect a hazard ratio of 0.70. NORM-HF will evaluate whether continuous congestion monitoring coupled with physician-directed patient self-management can reduce HF events and improve clinical outcomes. ClinicalTrials.gov Identifier: NCT07574593.
Code of conduct/disclaimer available in General Terms & Conditions
{{ help_message }}
{{filter}}