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Completed

NCT Number: NCT07743125

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Froedtert Menomonee Falls Hospital

Menomonee Falls, Wisconsin, 53051, United States

About this study

Non-randomized, prospective, single-center feasibility study. Participants who complete the study function as their own comparative controls. Planned screening of 30 patients with planned enrollment of 15; actual enrollment was 21. Per protocol addendum, a retrospective chart-review cohort (N=31 patients with a CardioMEMS device and 6 months of data from implant date, not included in the prospective arm) serves as a control/baseline comparison using data already in the medical record; no additional visits, questionnaires, or blood draws were required for that cohort. Adverse events were pre-defined in the protocol as: hypokalemia, hospitalization, syncope, urgent clinic/ER visit, and acute kidney injury.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Hospitalization(s)

    Time frame: 90 days

    All cause and adjudicated heart failure specific hospitalization(s)

  2. Urgent office visit(s)

    Time frame: 90 days

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

  3. Adverse event(s)

    Time frame: 90 days

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

  4. Diastolic pulmonary artery pressure average

    Time frame: 90 days

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

  5. Provider/treatment team intervention(s)

    Time frame: 90 days

    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.

Secondary outcomes

  1. Time in optimal PA pressure range (TIR-PAP)

    Time frame: 90 days

    within +/- 5mmHg of individual patient PA diastolic goal

  2. Diuretic burst frequency

    Time frame: 90 days

    Determined by episodes of sustained pressure deviations from goal range which require a patient self-adjustment/burst of medication(s) according to their individualized treatment plan.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Official study title

SURPASS-HF: Safety and Utility of Remote Pulmonary Artery Sensor Shared-management in Heart Failure

Acronym: SURPASS-HF

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 3, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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