Pragmatic Urinary Sodium-based Treatment algoritHm in Acute Heart Failure

Heart Failure Acute Clinical Trial

— PUSH-AHF  

Official title:

Pragmatic Urinary Sodium-based Treatment algoritHm in Acute Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04606927
• Other study ID #: 2020000710
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: November 2023
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Administration of loop diuretics to achieve decongestion is the current cornerstone of therapy for acute heart failure. Unfortunately, there is a lack of evidence of how to guide diuretic treatment. Recently, urinary sodium, as a response measure of diuretic response, has been proposed as a target for therapy. The hypothesis of this study is that natriuresis guided therapy in patients with acute heart failure will improve diuretic response, decongestion, and reduce length of hospital stay, as well as heart failure rehospitalisations.

Description:

Objective: To assess the effect of natriuresis guided therapy in acute heart failure to improve diuretic response, decongestion, and clinical outcomes Study design: Randomised, controlled, open label study Study population: 310 patients admitted with the primary diagnosis of acute heart failure requiring intravenous loop diuretics. Intervention: natriuresis guided treatment versus standard of care Main study parameters/endpoints: Co-primary outcome: total natriuresis after 24 hours, and first occurrence of all-cause mortality or heart failure rehospitalisation at 6 months Secondary outcomes: 48- and 72-hours natriuresis, length of hospital stay, percentage change in NT-proBNP at 48 and 72 hours. Safety endpoint: doubling of serum creatinine at 24 or 48 hours, worsening heart failure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 310
• Est. completion date: June 1, 2023
• Est. primary completion date: May 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female = 18 years of age

2. Primary diagnosis of acute /decompensated heart failure as assessed by treating physician a. Acute Heart failure can be de novo or exacerbation of known heart failure and diagnosis is based on criteria in the ESC HF guidelines

3. Requirement of intravenous diuretic use

Exclusion Criteria:

1. Dyspnoea primarily due to non-cardiac causes

2. Patients with severe renal impairment receiving dialysis or requiring ultrafiltration

3. Inability to follow instructions

4. Any other medical conditions that may put the patient at risk or influence study results in the investigator's opinion, or that the investigator deems unsuitable for the study

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure Acute

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety Endpoint: Doubling of Serum Creatinine at 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.	24 hours
Other	Safety Endpoint: Doubling of Serum Creatinine at 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.	48 hours
Other	Worsening Heart Failure	The third safety endpoint is defined as the number of patients with worsening heart failure during hospitalization.	During the index hospitalization (variable)
Primary	Total Natriuresis After 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).	24 hours
Primary	First Occurrence of All-cause Mortality or Heart Failure Rehospitalization After 180 Days		180 days
Secondary	48-hours Natriuresis	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).	48 hours
Secondary	72-hours Natriuresis	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).	72 hours
Secondary	Length of Hospital Stay	Number of days of the index hospitalization	Variable
Secondary	Percentage Change in NT-proBNP at 48 Hours	Relative NT-proBNP change (%) after 48 hours compared with baseline	48 hours
Secondary	Percentage Change in NT-proBNP at 72 Hours	Relative NT-proBNP change (%) after 72 hours compared with baseline	72 hours