Short-term changes in pulmonary congestion depending on diuretic administration method

JRCT ID: jRCT1041230150

Registered date:07/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: heart failure
• Date of first enrollment: 07/02/2024
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Patients will be assigned to receive either 16 mg of tolvaptan sodium phosphate intravenously over 1 hour once daily or 15 mg of tolvaptan orally once daily for up to 7 days. Standard laboratory tests, including catheterization, will be performed to measure pulmonary fluid concentrations using the reds system.

Outcome(s)

• Primary Outcome: Rate of change in pulmonary fluid concentration from pre-dose values and rate of improvement with the Remote Dielectric Sensing (reds) system.
• Secondary Outcome: Changes in urine output, weight, blood tests, and right heart catheterization

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

1. patients between 20 and 80 years of age
2. systolic blood pressure greater than 100 mmHg and heart rate less than 100 beats/minute at the time of enrollment
3. patients who are taking 20 mg of furosemide and are not receiving intravenous diuretics
4. Patients whose consent to participate in this study has been obtained by signing a consent form by the patient or a substitute consenter.

Exclude criteria

1. patients with cardiogenic shock (with continuous catecholamine administration and mechanical circulatory support)
2. patients with serum Na concentration less than 125 mEq/l or greater than 145 mEq/l
3. patients whose participation is deemed inappropriate by the attending physician
4. dialysis patients
5. patients who have difficulty with oral fluid intake

Related Information

• Primary Sponsor: Ohtani Hayato