Status:
UNKNOWN
Systematic Escalation of diuREtics With Natriuresis in Heart Failure Patients: SERENA Trial
Lead Sponsor:
University of Turin, Italy
Conditions:
Heart Failure
Eligibility:
All Genders
18-99 years
Phase:
PHASE3
Brief Summary
The present is a multicenter, prospective, randomized, open-label, blinded end-point trial aiming to investigate the clinical benefit of a stepwise, natriuresis-driven diuretic strategy versus standar...
Eligibility Criteria
Inclusion
- Admission for acute decompensate chronic heart failure or acute de novo heart failure
- Ejection Fraction \<40%
- Severe signs and symptoms of congestion with modified wet score ≥ 12
- Spot urinary sodium excretion ≤ 70 mEq/L at 2 hours from first intravenous loop diuretic administration
- Systolic blood pressure ≥90 mmHg
Exclusion
- Reversible etiology of acute heart failure (including acute coronary syndromes, myocarditis, acute pulmonary embolism, acute rhythm disorders, severe organic valve disease)
- Cardiogenic shock at admission or sign of hypoperfusion needing inotropic agents or mechanical circulatory support.
- eGFR lower than 15 ml/min/1.73m2 or dialysis
- Pregnancy or breastfeeding
Key Trial Info
Start Date :
October 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT04907123
Start Date
October 1 2021
End Date
January 1 2025
Last Update
May 28 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
A.O.U. Città della Salute e della Scienza di Torino
Torino, To, Italy, 10126