Patient-Executed, Clinician-Confirmed Diuretic Titration in Pulmonary Artery Pressure-Guided Heart Failure (SURPASS-HF)

NCT07743125 | Completed

• 1 other identifier: PRO00056040
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

heart failure; pulmonary artery pressure monitoring; remote hemodynamic monitoring; large language model; patient self-management

Outcome Measures

Primary Outcomes (5)

• Hospitalization(s)

  All cause and adjudicated heart failure specific hospitalization(s)

  90 days

• Urgent office visit(s)

  Unscheduled visits to outpatient office, urgent care, or emergency department for heart failure symptom or management of consequence directly related to heart failure management.

  90 days

• Adverse event(s)

  Events include syncope, acute kidney injury/failure, or significant electrolyte derangements requiring intravenous corrective therapy that were directly due to heart failure treatment(s).

  90 days

• Diastolic pulmonary artery pressure average

  Cohort wide average PA diastolic pressure during the first two weeks and last two weeks of study period.

  90 days

• Provider/treatment team intervention(s)

  Either by request from patient or necessity deemed by provider/treatment team, intervention that was not explicitly outlined in the patient specific protocol/therapy titration adjustment plan.

  90 days

Secondary Outcomes (2)

• Time in optimal PA pressure range (TIR-PAP)

  90 days

• Diuretic burst frequency

  90 days

Study Arms (1)

Shared Management

EXPERIMENTAL

Participants received a simplified treatment guide / sliding scale with instruction to adjust diuretic dosing according to remotely obtained pulmonary artery pressures, relayed to the patient daily via the Epic MyChart portal, under a previously published hemodynamic treatment algorithm with protocol-mandated laboratory testing after diuretic augmentation.

Other: Shared-management diuretic titration guided by remote PA pressure monitoring

Interventions

Shared-management diuretic titration guided by remote PA pressure monitoring OTHER

Participants received a simplified treatment guide / sliding scale with instruction to adjust diuretic dosing according to remotely obtained pulmonary artery pressures, relayed to the patient daily via the Epic MyChart portal, under a previously published hemodynamic treatment algorithm with protocol-mandated laboratory testing after diuretic augmentation.

Shared Management

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert Menomonee Falls Hospital

Menomonee Falls, Wisconsin, 53051, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending, Cardiovascular Medicine

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 3, 2026
• Study Start: January 14, 2026
• Primary Completion: April 14, 2026
• Study Completion: April 14, 2026
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Pending publication in peer reviewed journal + 3 months
• Access Criteria: Primary author, physically accessible in person only. Data encrypted on drive in physically secured location.

Locations

US (1)