NCT04907123

Systematic Escalation of diuREtics With Natriuresis in Heart Failure Patients: SERENA Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 198 (estimated)
• Sponsor: University of Turin, Italy · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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 standard diuretic treatment in patients with acute decompensated heart failure with reduced ejection fraction (HFrEF) and low early urinary sodium excretion. The study will focus on patients at increased risk of resistance to diuretic therapy. In particular, patients admitted to the emergency department and cardiac intensive care unit due to an on-chronic or de-novo acute decompensated HF episode with a predominantly "wet" profile and low early spot urinary sodium (UNa+) excretion will be considered. Spot natriuresis is a low-cost, non-demanding laboratory test in use to identify diuretic-resistant patients with an inherent poor prognosis. Whether the early identification of diuretic resistant patients and the consequent more aggressive treatment may lead to a better outcome has not been demonstrated by randomized studies. This trial aims to assess if an intensive stepwise diuretic approach guided by systematic urinary output assessment including natriuresis evaluation versus a standard diuretic strategy based on urinary output alone effectively leads to faster euvolemia achievement and better prognosis in a real-world setting.

Conditions

• Heart Failure

Interventions

Type	Name	Description
OTHER	Intensive sodiuria-guided diuretic treatment	Intensive stepwise diuretic treatment based on combined diuresis and urinary sodium assessment
OTHER	Standard diuretic treatment	Stepwise diuretic therapy based on diuresis assessment

Timeline

• Start date: 2021-10-01
• Primary completion: 2024-10-01
• Completion: 2025-01-01
• First posted: 2021-05-28
• Last updated: 2021-05-28

Locations

1 site across 1 country: Italy