VAPorized Administration of Bumetanide for Outpatient Relief in Heart Failure

NCT07375212 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 2341204
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Heart Failure Congestive

Keywords

VAPOR-HF; Nasal Bumex; Nasal Bumetanide; Intranasal Bumex; Intranasal Bumetanide

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours post-dose

Secondary Outcomes (2)

• Quantify the Change in Total Blood Volume

  24 hours post-dose

• Changes in Pertinent Labs

  24 hours post-dose

Study Arms (1)

Intranasal Bumetanide Recipient

OTHER

All subjects in this study will receive the interventional drug, 4mg intranasal bumetanide,

Drug: Bumetanide, intranasal 4mg

Interventions

Bumetanide, intranasal 4mg DRUG

Intranasal route of administration for 4mg of bumetanide

Also known as: Intranasal Bumex

Intranasal Bumetanide Recipient

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prisma Health-Upstate: lead

Study Sites (1)

Prisma Health

Greenville, South Carolina, 29605, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Bumetanide

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Jason L Guichard, MD, PhD

  Prisma Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: January 29, 2026
• Study Start: January 21, 2026
• Primary Completion: January 21, 2026
• Study Completion: January 21, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)