Heart FailureSURPASS-HFNCT07743125
Patient-Executed, Clinician-Confirmed Diuretic Titration in Pulmonary Artery Pressure-Guided Heart Failure (SURPASS-HF)
A study testing Shared-management diuretic titration guided by remote PA pressure monitoring in people with Heart Failure, run by Medical College of Wisconsin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Shared-management diuretic titration guided by remote PA pressure monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2026to 14 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, 53051
About this study
Official title: SURPASS-HF: Safety and Utility of Remote Pulmonary Artery Sensor Shared-management in Heart Failure
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.
Read the detailed description
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.
- Conditions
- Heart Failure
- Being tested
- Shared-management diuretic titration guided by remote PA pressure monitoring
- Keywords
- heart failure, pulmonary artery pressure monitoring, remote hemodynamic monitoring, large language model, patient self-management
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared-management diuretic titration guided by remote PA pressure monitoringOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Shared-management diuretic titration guided by remote PA pressure monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization(s)
All cause and adjudicated heart failure specific hospitalization(s)
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 90 days
Secondary outcomes (2)
Time in optimal PA pressure range (TIR-PAP)
within +/- 5mmHg of individual patient PA diastolic goal
Measured: 90 days
Diuretic burst frequency
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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start14 Jan 2026
- Primary completion14 Apr 2026
- Study completion14 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Atzenhoefer, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07743125
- Sponsor's protocol ID
- PRO00056040
- Acronym
- SURPASS-HF
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data are held in a locked, hash-verified dataset and will be shared on reasonable request to the principal investigator, subject to institutional and ethical approvals.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SURPASS-HF: Safety and Utility of Remote Pulmonary Artery Sensor Shared-management in Heart Failure
- ClinicalTrials.gov ID
- NCT07743125
- Acronym / sponsor ID
- SURPASS-HF / PRO00056040
- Conditions
- Heart Failure
- Keywords
- heart failure, pulmonary artery pressure monitoring, remote hemodynamic monitoring, large language model, patient self-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 14 Jan 2026 (actual)
- Primary completion
- 14 Apr 2026 (actual)
- Study completion
- 14 Apr 2026 (actual)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shared Management | Experimental | Other: Shared-management diuretic titration guided by remote PA pressure monitoringParticipants 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. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shared-management diuretic titration guided by remote PA pressure monitoringParticipants 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 |
Primary outcome
Hospitalization(s)
Time frame: 90 days
All cause and adjudicated heart failure specific hospitalization(s)
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.
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).
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.
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.
2 secondary outcomes
Time in optimal PA pressure range (TIR-PAP)
Time frame: 90 days
Diuretic burst frequency
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data are held in a locked, hash-verified dataset and will be shared on reasonable request to the principal investigator, subject to institutional and ethical approvals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shared-management diuretic titration guided by remote PA pressure monitoring in people with Heart Failure, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalization(s) (time frame: 90 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.