VAPorized Administration of Bumetanide for Outpatient Relief in Heart Failure (VAPOR-HF)

January 21, 2026 updated by: Prisma Health-Upstate

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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Prisma Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Intranasal Bumetanide Recipient
All subjects in this study will receive the interventional drug, 4mg intranasal bumetanide,
Drug: Bumetanide, intranasal 4mg
Intranasal route of administration for 4mg of bumetanide
Other Names:
  • Intranasal Bumex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours post-dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantify the Change in Total Blood Volume
Time Frame: 24 hours post-dose
Quantify the change in total blood volume in milliliters 24 hours post-dose of intranasal bumex.
24 hours post-dose
Changes in Pertinent Labs
Time Frame: 24 hours post-dose
Describe the changes in the following labs at 24 hours post-dose of intranasal bumex: NT-proBNP, serum electrolytes, creatinine, hemoglobin, and hematocrit
24 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prisma Health-Upstate

Investigators

  • Principal Investigator: Jason L Guichard, MD, PhD, Prisma Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2026

Primary Completion (Actual)

January 21, 2026

Study Completion (Actual)

January 21, 2026

Study Registration Dates

First Submitted

July 16, 2025

First Submitted That Met QC Criteria

January 21, 2026

First Posted (Actual)

January 29, 2026

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 21, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2341204

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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