Trial Outcomes & Findings for Aquaresis Utility for Hyponatremic Acute Heart Failure Study (NCT NCT02183792)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

33 participants

Primary outcome timeframe

24 hours post randomization

Results posted on

2019-05-28

Participant Flow

Participant milestones

Participant milestones
Measure	Tolvaptan Tolvaptan 30-60mg once daily (with rescue loop diuretic or metolazone) Tolvaptan	Furosemide Furosemide continuous infusion 5mg/h with option to titrate (with rescue metolazone) Furosemide
Overall Study STARTED	18	15
Overall Study COMPLETED	18	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tolvaptan n=18 Participants Tolvaptan 30-60mg once daily (with rescue loop diuretic or metolazone) Tolvaptan	Furosemide n=15 Participants Furosemide continuous infusion 5mg/h with option to titrate (with rescue metolazone) Furosemide	Total n=33 Participants Total of all reporting groups
Age, Continuous	53 years STANDARD_DEVIATION 11.7 • n=18 Participants	59 years STANDARD_DEVIATION 8.9 • n=15 Participants	56 years STANDARD_DEVIATION 10.8 • n=33 Participants
Sex: Female, Male Female	7 Participants n=18 Participants	1 Participants n=15 Participants	8 Participants n=33 Participants
Sex: Female, Male Male	11 Participants n=18 Participants	14 Participants n=15 Participants	25 Participants n=33 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	18 participants n=18 Participants	15 participants n=15 Participants	33 participants n=33 Participants
Home Loop Diuretic Dose (Furosemide equivalents)	93 mg STANDARD_DEVIATION 63.5 • n=18 Participants	108 mg STANDARD_DEVIATION 77.5 • n=15 Participants	100 mg STANDARD_DEVIATION 68.5 • n=33 Participants

PRIMARY outcome

Timeframe: 24 hours post randomization

Outcome measures

Outcome measures
Measure	Tolvaptan n=18 Participants Tolvaptan 30-60mg once daily (with rescue loop diuretic or metolazone) Tolvaptan	Furosemide n=15 Participants Furosemide continuous infusion 5mg/h with option to titrate (with rescue metolazone) Furosemide
Median Urine Output at 24 Hours Post Randomization	2910 mL Interval 1100.0 to 4225.0	3150 mL Interval 2375.0 to 5680.0

SECONDARY outcome

Timeframe: 24 hours post randomization

Comparison between baseline and 24 hours post randomization concentrations.

Outcome measures

Outcome measures
Measure	Tolvaptan n=18 Participants Tolvaptan 30-60mg once daily (with rescue loop diuretic or metolazone) Tolvaptan	Furosemide n=15 Participants Furosemide continuous infusion 5mg/h with option to titrate (with rescue metolazone) Furosemide
Median Change in Serum Creatinine at 24 Hours Post Randomization Median 24h Change	-0.08 mg/dL Interval -0.14 to -0.04	-0.01 mg/dL Interval -0.19 to 0.15
Median Change in Serum Creatinine at 24 Hours Post Randomization Median Scr at Baseline	1.15 mg/dL Interval 0.88 to 1.51	0.87 mg/dL Interval 0.76 to 1.22
Median Change in Serum Creatinine at 24 Hours Post Randomization Median Scr at 24h	1.06 mg/dL Interval 0.76 to 1.37	0.96 mg/dL Interval -0.19 to 1.53

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 5 days

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days

Difference assessed at baseline, 8, 24, 48, 72 and 96 hours.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days

Difference assessed at baseline, 8, 24, 48, 72 and 96 hours.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: At baseline, 24 and 96 hours post randomization

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days

Hypo- and hyperkalemia defined as outside the range of 3.5 to 5.0 mEq/L Hypo- and hypermagnesemia defined as outside the range of 1.5-2.4 mEq/L

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: At baseline, 24 and 96 hours post randomization

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: At baseline, 24 and 96 hours post randomization

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: At baseline, 24 and 96 hours post randomization

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: At baseline, 24 and 96 hours post randomization

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: At baseline, 24, 48, 72 and 96 hours post randomization

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 5 days

Outcome measures

Outcome data not reported

Adverse Events

Tolvaptan

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Furosemide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tien Ng, Pharm.D.

University of Southern California School of Pharmacy

Phone: 3234421840

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place