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Pragmatic Urinary Sodium-based Treatment algoritHm in Acute Heart Failure (PUSH-AHF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04606927
Recruitment Status : Completed
First Posted : October 28, 2020
Results First Posted : April 22, 2024
Last Update Posted : April 22, 2024
Sponsor:
Information provided by (Responsible Party):
Jozine ter Maaten, University Medical Center Groningen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Heart Failure Acute
Intervention Other: Natriuresis
Enrollment 310
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Natriuresis Guided Treatment Standard of Care
Hide Arm/Group Description 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
Period Title: Overall Study
Started 150 160
Completed 150 160
Not Completed 0 0
Arm/Group Title Natriuresis Guided Treatment Standard of Care Total
Hide Arm/Group Description 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 Total of all reporting groups
Overall Number of Baseline Participants 150 160 310
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 150 participants 160 participants 310 participants
74
(66 to 82)
74
(65 to 81)
74
(65 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants 160 participants 310 participants
Female
61
  40.7%
77
  48.1%
138
  44.5%
Male
89
  59.3%
83
  51.9%
172
  55.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants 160 participants 310 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
142
  94.7%
155
  96.9%
297
  95.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
8
   5.3%
5
   3.1%
13
   4.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Netherlands Number Analyzed 150 participants 160 participants 310 participants
150 160 310
1.Primary Outcome
Title Total Natriuresis After 24 Hours
Hide Description 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).
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Natriuresis Guided Treatment Standard of Care
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 131 147
Mean (Standard Deviation)
Unit of Measure: mmol
409  (178) 345  (202)
2.Primary Outcome
Title First Occurrence of All-cause Mortality or Heart Failure Rehospitalization After 180 Days
Hide Description [Not Specified]
Time Frame 180 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Natriuresis Guided Treatment Standard of Care
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 150 159
Measure Type: Count of Participants
Unit of Measure: Participants
46
  30.7%
50
  31.4%
3.Secondary Outcome
Title 48-hours Natriuresis
Hide Description 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).
Time Frame 48 hours
Outcome Measure Data Not Reported
4.Secondary Outcome
Title 72-hours Natriuresis
Hide Description 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).
Time Frame 72 hours
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Length of Hospital Stay
Hide Description Number of days of the index hospitalization
Time Frame Variable
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Percentage Change in NT-proBNP at 48 Hours
Hide Description Relative NT-proBNP change (%) after 48 hours compared with baseline
Time Frame 48 hours
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Percentage Change in NT-proBNP at 72 Hours
Hide Description Relative NT-proBNP change (%) after 72 hours compared with baseline
Time Frame 72 hours
Outcome Measure Data Not Reported
8.Other Pre-specified Outcome
Title Safety Endpoint: Doubling of Serum Creatinine at 24 Hours
Hide Description The first safety endpoint is defined as number of patients with a doubling of serum creatinine at 24 hours compared with baseline serum creatinine.
Time Frame 24 hours
Outcome Measure Data Not Reported
9.Other Pre-specified Outcome
Title Safety Endpoint: Doubling of Serum Creatinine at 48 Hours
Hide Description 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.
Time Frame 48 hours
Outcome Measure Data Not Reported
10.Other Pre-specified Outcome
Title Worsening Heart Failure
Hide Description The third safety endpoint is defined as the number of patients with worsening heart failure during hospitalization.
Time Frame During the index hospitalization (variable)
Outcome Measure Data Not Reported
Time Frame During the study period (6 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Natriuresis Guided Treatment Standard of Care
Hide Arm/Group Description 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
All-Cause Mortality
Natriuresis Guided Treatment Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   29/150 (19.33%)      33/160 (20.63%)    
Hide Serious Adverse Events
Natriuresis Guided Treatment Standard of Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   60/150 (40.00%)      70/160 (43.75%)    
Cardiac disorders     
Diverse *  60/150 (40.00%)  60 70/160 (43.75%)  70
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Natriuresis Guided Treatment Standard of Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/150 (0.00%)      0/160 (0.00%)    
Cardiac disorders     
Other *  0/150 (0.00%)  0/160 (0.00%) 
*
Indicates events were collected by non-systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jozine ter Maaten
Organization: University Medical Center Groningen
Phone: 0503616161
EMail: j.m.ter.maaten@umcg.nl
Layout table for additonal information
Responsible Party: Jozine ter Maaten, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT04606927    
Other Study ID Numbers: 2020000710
First Submitted: October 18, 2020
First Posted: October 28, 2020
Results First Submitted: November 1, 2023
Results First Posted: April 22, 2024
Last Update Posted: April 22, 2024