Pragmatic Urinary Sodium-based treatment algoritHm in Acute Heart Failure
Not yet recruiting
- Conditions
- 10019280Acute heart failure
- Registration Number
- NL-OMON55107
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 310
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Co-primary outcome: total natriuresis after 24-hours first occurrence of heart<br /><br>failure hospitalization or all-cause mortality after 6 months. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes: 48- and 72-hour sodium excretion, length of hospital stay,<br /><br>and percentage change in NT-proBNP at 48 and 72 hours<br /><br>Safety endpoint: doubling of serum creatinine at 24- or 48-hours. </p><br>