Heart Failure CongestivePhase 4VAPOR-HFNCT07375212
VAPorized Administration of Bumetanide for Outpatient Relief in Heart Failure
A Phase 4 study testing Bumetanide, intranasal 4mg in people with Heart Failure Congestive, run by Prisma Health-Upstate at 1 site in United States.
Trial summary
This trial is seeking to determine whether a single 4mg intranasal dose of bumetanide acutely reduces pulmonary artery pressure and blood volume in the outpatient setting for patients with heart failure and an implanted device for remote patient monitoring (i.e. Cordella or CardioMEMS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure Congestive
- What is being tested?
- Bumetanide, intranasal 4mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2026to 21 Jan 2026
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 y with chronic HF (NYHA II-III).
- Successful CardioMEMS or Cordella implantation ≥ 3 months prior.
- Clinically mild or worse congestion (no IV diuretics within 7 days).
- eGFR ≥ 20 mL/min/1.73 m²; serum K⁺ 3.5-5.2 mmol/L.
Who cannot join
- SBP < 90 mmHg, HR < 50 bpm, or > 110 bpm at baseline.
- Acute HF hospitalization < 30 days.
- Chronic nasal pathology or recent intranasal surgery.
- Known allergy to bumetanide or sulfamides.
- Pregnancy or lactation.
- Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device which has not reached its primary endpoint.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Hemodynamic and Blood Volume Effects of Single-Dose Intranasal Bumetanide in Patients Implanted With the CardioMEMS™ and Cordella™ HF Systems: a 24-Hour Prospective Pilot Study
This trial is seeking to determine whether a single 4mg intranasal dose of bumetanide acutely reduces pulmonary artery pressure and blood volume in the outpatient setting for patients with heart failure and an implanted device for remote patient monitoring (i.e. Cordella or CardioMEMS).
- Conditions
- Heart Failure Congestive
- Being tested
- Bumetanide, intranasal 4mg
- Keywords
- VAPOR-HF, Nasal Bumex, Nasal Bumetanide, Intranasal Bumex, Intranasal Bumetanide
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bumetanide, intranasal 4mgDrug
Also called Intranasal Bumex
Intranasal route of administration for 4mg of bumetanide
| Study group | Role | What they receive |
|---|---|---|
| Intranasal Bumetanide Recipient | Other | All subjects in this study will receive the interventional drug, 4mg intranasal bumetanide, Receives: Drug: Bumetanide, intranasal 4mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize Temporal Changes
Characterize temporal changes in mean pulmonary artery pressure, systolic pulmonary artery pressure, diastolic pulmonary artery pressure, and heart rate at 1, 2, 3, 6, 12, and 24 hours post-dose of intranasal bumex.
Measured: 24 hours post-dose
Secondary outcomes (2)
Quantify the Change in Total Blood Volume
Quantify the change in total blood volume in milliliters 24 hours post-dose of intranasal bumex.
Measured: 24 hours post-dose
Changes in Pertinent Labs
Describe the changes in the following labs at 24 hours post-dose of intranasal bumex: NT-proBNP, serum electrolytes, creatinine, hemoglobin, and hematocrit
Measured: 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start21 Jan 2026
- Primary completion21 Jan 2026
- Study completion21 Jan 2026
Why it stopped: Change in Sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure CongestiveStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason L Guichard, MD, PhD, Principal investigator, Prisma Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07375212
- Sponsor's protocol ID
- 2341204
- Acronym
- VAPOR-HF
- Status last verified
- Jan 2026
- First submitted
- 16 Jul 2025
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Hemodynamic and Blood Volume Effects of Single-Dose Intranasal Bumetanide in Patients Implanted With the CardioMEMS™ and Cordella™ HF Systems: a 24-Hour Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT07375212
- Acronym / sponsor ID
- VAPOR-HF / 2341204
- Conditions
- Heart Failure Congestive
- Keywords
- VAPOR-HF, Nasal Bumex, Nasal Bumetanide, Intranasal Bumex, Intranasal Bumetanide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in Sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Study start
- 21 Jan 2026 (actual)
- Primary completion
- 21 Jan 2026 (actual)
- Study completion
- 21 Jan 2026 (actual)
- First posted
- 29 Jan 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.
This trial is seeking to determine whether a single 4mg intranasal dose of bumetanide acutely reduces pulmonary artery pressure and blood volume in the outpatient setting for patients with heart failure and an implanted device for remote patient monitoring (i.e. Cordella or CardioMEMS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intranasal Bumetanide Recipient | Other | Drug: Bumetanide, intranasal 4mgAll subjects in this study will receive the interventional drug, 4mg intranasal bumetanide, |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 y with chronic HF (NYHA II-III).
- Successful CardioMEMS or Cordella implantation ≥ 3 months prior.
- Clinically mild or worse congestion (no IV diuretics within 7 days).
- eGFR ≥ 20 mL/min/1.73 m²; serum K⁺ 3.5-5.2 mmol/L.
Key exclusion criteria (6 listed)
- SBP < 90 mmHg, HR < 50 bpm, or > 110 bpm at baseline.
- Acute HF hospitalization < 30 days.
- Chronic nasal pathology or recent intranasal surgery.
- Known allergy to bumetanide or sulfamides.
- Pregnancy or lactation.
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 |
|---|---|---|
| Bumetanide, intranasal 4mgAlso: Intranasal BumexIntranasal route of administration for 4mg of bumetanide | Drug | Intranasal Bumetanide Recipient |
Primary outcome
Characterize Temporal Changes
Time frame: 24 hours post-dose
Characterize temporal changes in mean pulmonary artery pressure, systolic pulmonary artery pressure, diastolic pulmonary artery pressure, and heart rate at 1, 2, 3, 6, 12, and 24 hours post-dose of intranasal bumex.
2 secondary outcomes
Quantify the Change in Total Blood Volume
Time frame: 24 hours post-dose
Changes in Pertinent Labs
Time frame: 24 hours post-dose
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Jason L Guichard, MD, PhD principal investigator
Prisma Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bumetanide, intranasal 4mg in people with Heart Failure Congestive, run by Prisma Health-Upstate 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 4 inclusion and 6 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: withdrawn, as of the sponsor's last update on 29 Jan 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Characterize Temporal Changes (time frame: 24 hours post-dose). 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 29 Jan 2026.