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Short-term changes in pulmonary congestion depending on how diuretics are administered to patients with heart failure

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

3

The age of the subjects ranged from 52 to 78 years. All subjects were male. Left ventricular ejection fraction ranged from 25% to 60%. Serum Cre ranged from 0.65 to 2.3 mg/dl.

The target number of cases could not be reached because there were fewer heart failure admissions than originally anticipated.

No adverse event occurred

Statistical analysis of the primary and secondary endpoints was not performed because the target number of patients was not reached.

It was suggested that tolvaptan sodium phosphate ester injection may improve pulmonary congestion faster than tolvaptan orally disintegrating tablets.

No

https://jrct.mhlw.go.jp/latest-detail/jRCT1041230150

Ohtani Hayato

Hamamatsu University School of Medicine

1-20-1 Handayama Chuo Ward Hamamatsu city Shizuoka

ohtani@hama-med.ac.jp

Ohtani Hayato

Hamamatsu University School of Medicine

1-20-1 Handayama Chuo Ward Hamamatsu city Shizuoka prefecture

+81-53-435-2267

ohtani@hama-med.ac.jp

Complete

Feb. 07, 2024

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

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.

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

Both

heart failure

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.

Rate of change in pulmonary fluid concentration from pre-dose values and rate of improvement with the Remote Dielectric Sensing (reds) system.

Changes in urine output, weight, blood tests, and right heart catheterization

+81-53-435-2680

Jan. 23, 2024

none