To assess the effect of natriuresis guided therapy in acute heart failure to improve diuretic response, decongestion, and clinical outcomes
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Co-primary outcome: total natriuresis after 24-hours first occurrence of heart
failure hospitalization or all-cause mortality after 6 months.
Secondary outcome
Secondary outcomes: 48- and 72-hour sodium excretion, length of hospital stay,
and percentage change in NT-proBNP at 48 and 72 hours
Safety endpoint: doubling of serum creatinine at 24- or 48-hours.
Background 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.
Study 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
Intervention
Natriuresis guided treatment versus standard of care
Study burden and risks
Since this is a pragmatic trial, the study will be embedded within the normal
care of patients with acute heart failure, which already includes timed urinary
collections and laboratory assessment at set time points. The patients in the
natriuresis guided therapy will undergo additional urinary assessments, and
undergo more stringent monitoring of response, and therefore might receive more
intravenous diuretics. For study parameters, blood and urine will be collected
at set time points. Survival and rehospitalisation will be assessed after 6
months by telephone call.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
1. Male of female >= 18 years of age
2. Primary diagnosis of acute/decompensated heart failure as assessed by
treating physician
a. Acute heart failure 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 failure impairment receiving dialysis or
requiring ultrafiltration
3. Inability to follow instructions
4. Previous participation in this study
5. Any 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04606927 |
| CCMO | NL75163.042.20 |