Trial Outcomes & Findings for Pragmatic Urinary Sodium-based Treatment algoritHm in Acute Heart Failure (NCT NCT04606927)

Results Overview

The first component of the co-primary end-point is total natriuresis after 24 h (mmol). To assess this, urine is collected for 24 hours after the first administration of diuretics according to the study protocol and natriuresis is calculated as the total amount of diuresis (L) multiplied by the urinary sodium concentration (mmol/L).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

310 participants

Primary outcome timeframe

24 hours

Results posted on

2024-04-22

Participant Flow

Participant milestones

Participant milestones
Measure	Natriuresis Guided Treatment Natriuresis: Patients with insufficient decongestive response based on natriuresis (in the active arm) will be eligible for treatment adjustments according to the natriuresis guided treatment algorithm.	Standard of Care Standard of care
Overall Study STARTED	150	160
Overall Study COMPLETED	150	160
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pragmatic Urinary Sodium-based Treatment algoritHm in Acute Heart Failure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Natriuresis Guided Treatment n=150 Participants Natriuresis: Patients with insufficient decongestive response based on natriuresis (in the active arm) will be eligible for treatment adjustments according to the natriuresis guided treatment algorithm.	Standard of Care n=160 Participants Standard of care	Total n=310 Participants Total of all reporting groups
Age, Continuous	74 years n=5 Participants	74 years n=7 Participants	74 years n=5 Participants
Sex: Female, Male Female	61 Participants n=5 Participants	77 Participants n=7 Participants	138 Participants n=5 Participants
Sex: Female, Male Male	89 Participants n=5 Participants	83 Participants n=7 Participants	172 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	142 Participants n=5 Participants	155 Participants n=7 Participants	297 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment Netherlands	150 participants n=5 Participants	160 participants n=7 Participants	310 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

The first component of the co-primary end-point is total natriuresis after 24 h (mmol). To assess this, urine is collected for 24 hours after the first administration of diuretics according to the study protocol and natriuresis is calculated as the total amount of diuresis (L) multiplied by the urinary sodium concentration (mmol/L).

Outcome measures

Outcome measures
Measure	Natriuresis Guided Treatment n=131 Participants Natriuresis: Patients with insufficient decongestive response based on natriuresis (in the active arm) will be eligible for treatment adjustments according to the natriuresis guided treatment algorithm.	Standard of Care n=147 Participants Standard of care
Total Natriuresis After 24 Hours	409 mmol Standard Deviation 178	345 mmol Standard Deviation 202

PRIMARY outcome

Timeframe: 180 days

Outcome measures

Outcome measures
Measure	Natriuresis Guided Treatment n=150 Participants Natriuresis: Patients with insufficient decongestive response based on natriuresis (in the active arm) will be eligible for treatment adjustments according to the natriuresis guided treatment algorithm.	Standard of Care n=159 Participants Standard of care
First Occurrence of All-cause Mortality or Heart Failure Rehospitalization After 180 Days	46 Participants	50 Participants

SECONDARY outcome

Timeframe: 48 hours

48-hour natriuresis will be assessed by collecting urine for a second period of 24 hours after the first 24-hour urine collection according to the study protocol and natriuresis is calculated as the total amount of diuresis (L) multiplied by the urinary sodium concentration (mmol/L).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 72 hours

72-hour natriuresis will be assessed by collecting urine for a third period of 24 hours after the second 24-hour urine collection according to the study protocol and natriuresis is calculated as the total amount of diuresis (L) multiplied by the urinary sodium concentration (mmol/L).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Variable

Number of days of the index hospitalization

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 48 hours

Relative NT-proBNP change (%) after 48 hours compared with baseline

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 72 hours

Relative NT-proBNP change (%) after 72 hours compared with baseline

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 hours

The first safety endpoint is defined as number of patients with a doubling of serum creatinine at 24 hours compared with baseline serum creatinine.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 48 hours

The second safety endpoint is defined as the number of patients with a doubling of serum creatinine at 48 hours compared with baseline serum creatinine.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: During the index hospitalization (variable)

The third safety endpoint is defined as the number of patients with worsening heart failure during hospitalization.

Outcome measures

Outcome data not reported

Adverse Events

Natriuresis Guided Treatment

Serious events: 60 serious events

Other events: 0 other events

Deaths: 29 deaths

Standard of Care

Serious events: 70 serious events

Other events: 0 other events

Deaths: 33 deaths

Serious adverse events

Serious adverse events
Measure	Natriuresis Guided Treatment n=150 participants at risk Natriuresis: Patients with insufficient decongestive response based on natriuresis (in the active arm) will be eligible for treatment adjustments according to the natriuresis guided treatment algorithm.	Standard of Care n=160 participants at risk Standard of care
Cardiac disorders Diverse	40.0% 60/150 • Number of events 60 • During the study period (6 months)	43.8% 70/160 • Number of events 70 • During the study period (6 months)

Other adverse events

Other adverse events
Measure	Natriuresis Guided Treatment n=150 participants at risk Natriuresis: Patients with insufficient decongestive response based on natriuresis (in the active arm) will be eligible for treatment adjustments according to the natriuresis guided treatment algorithm.	Standard of Care n=160 participants at risk Standard of care
Cardiac disorders Other	0.00% 0/150 • During the study period (6 months)	0.00% 0/160 • During the study period (6 months)

Additional Information

Dr. Jozine ter Maaten

University Medical Center Groningen

Phone: 0503616161

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place