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

Prisma Health-Upstate

Status and phase: Withdrawn; Phase 4

Conditions: Heart Failure Congestive

Treatments: Drug: Bumetanide, intranasal 4mg

Study type: Interventional

Funder types: Other

Identifiers

NCT07375212

2341204

Details and patient eligibility

About

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).

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Intranasal Bumetanide Recipient

Other group

Description:

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

Treatment:

Drug: Bumetanide, intranasal 4mg