VAPorized Administration of Bumetanide for Outpatient Relief in Heart Failure
Megadott ok: Change in Sponsor
Key facts
- Where
- Greenville, Egyesült ÁllamokSee the site
- Phase
- 4. fázis
Where in Egyesült Államok
- Prisma HealthGreenville, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- Prisma Health-Upstate
- Trial code
- NCT07375212
- Record updated
- 2026. január 29.
- Original description
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 full original descriptionShow less
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).
Inclusion: 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: Chronic nasal pathology or recent intranasal surgery; 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; Known allergy to bumetanide or sulfamides; SBP < 90 mmHg, HR < 50 bpm, or > 110 bpm at baseline; Acute HF hospitalization < 30 days; Pregnancy or lactation.