Google Maps

NCT07743125

Overview

NCT ID: NCT07743125
Lead Sponsor: Medical College of WisconsinOTHER
Official Title: SURPASS-HF: Safety and Utility of Remote Pulmonary Artery Sensor Shared-management in Heart Failure
Brief Summary: SURPASS-HF was a 90-day, single-center, single-arm, prospective feasibility study asking whether adults with heart failure and an implanted pulmonary artery (PA) pressure sensor can safely share in managing their own diuretic (water pill) dosing. Participants were already implanted with a CardioMEMS PA pressure sensor and managed by a single cardiovascular team using a previously published hemodynamic treatment algorithm. Each participant received a simplified treatment guide (sliding scale) prescribing how to adjust diuretic doses based on their own PA pressure readings, which were relayed to them daily through the Epic MyChart patient portal. Protocol-mandated laboratory testing followed each diuretic adjustment. The study measured safety (hospitalizations, urgent visits, kidney injury, syncope, electrolyte disturbances) and effectiveness (heart failure hospitalizations, average PA diastolic pressure, and how often the care team needed to intervene) over 90 days, with quality of life assessed by the Minnesota Heart Failure Questionnaire. A separate retrospective chart-review cohort of 31 CardioMEMS patients served as a comparison group.

Status and Timeline

Status: Completed
Last Update Posted: Aug 3, 2026Actual
Start Date: Jan 14, 2026Actual
Primary Completion Date: Apr 14, 2026Actual
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria (prospective arm participants must meet ALL of 1-7; retrospective cohort inclusion limited to criterion 1):

Currently implanted with and actively transmitting remote pulmonary artery pressures using the CardioMEMS HF system and exclusively managed by the Froedtert Menomonee Falls Cardiovascular Team according to previously published hemodynamic treatment algorithm.

Provision of signed and dated informed consent

Stated willingness to comply with study procedure and mandates and remain available for the duration of the study period of 90 days.

Males and females; Ages 40-90

Documented diagnosis of heart failure (regardless of ejection fraction) with volume related symptoms managed with a loop diuretic.

Willingness to participate in a shared-management strategy

Access to necessary resources for participating in a technology-based intervention (i.e., Epic MyChart via computer, smartphone, or tablet with internet access)

Exclusion Criteria (any ONE excludes):

Allergy/intolerance to loop or thiazide diuretics.

Oliguria/anuria either acute or chronic.

Chronic kidney disease Stage IV, V, or undergoing renal replacement therapy.

Transplant organ recipient

Chronic immunosuppressant therapy

Idiopathic fluid collections (for example ascites, pulmonary or pericardial effusions)

Currently undergoing chemotherapy for malignancy or having received chemotherapeutic treatment in the past 12 months.

Hospice plan of care or prior designation of hospice plan of care within 12 months.

Advanced heart failure designation with or without durable mechanical circulatory support.

Technically or medically illiterate precluding use of Epic MyChart application.

Blister packaged medications

Resident of group/assisted living facility.

Either partially or completely dependent on social/family support for IADLs/ADLs

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 21Actual
Primary Purpose: Health Services Research
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: No data available
Locations: Froedtert Menomonee Falls Hospital

Overview

Status and Timeline

Participation Criteria

Study Plan

Contacts and Locations

Similar Studies