VAPorized Administration of Bumetanide for Outpatient Relief in Heart Failure

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

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07375212

Acronym

VAPOR-HF

Enrollment

Registered

2026-01-29

Start date

2026-01-21

Completion date

2026-01-21

Last updated

2026-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure Congestive

Keywords

VAPOR-HF, Nasal Bumex, Nasal Bumetanide, Intranasal Bumex, Intranasal Bumetanide

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).

Interventions

DRUGBumetanide, intranasal 4mg

Intranasal route of administration for 4mg of bumetanide

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Characterize Temporal Changes	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.

Secondary

Measure	Time frame	Description
Quantify the Change in Total Blood Volume	24 hours post-dose	Quantify the change in total blood volume in milliliters 24 hours post-dose of intranasal bumex.
Changes in Pertinent Labs	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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJason L Guichard, MD, PhD

Prisma Health

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026