NCT07375212撤回4 期
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
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Characterize Temporal Changes
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Intranasal Bumetanide Recipient
Other
All subjects in this study will receive the interventional drug, 4mg intranasal bumetanide,
干预措施: Bumetanide, intranasal 4mg (Drug)
结局指标
主要结局
Characterize Temporal Changes
时间窗: 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.
次要结局
- Quantify the Change in Total Blood Volume(24 hours post-dose)
- Changes in Pertinent Labs(24 hours post-dose)
研究者
研究点 (1)
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