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

NCT04907123 Phase 3 UNKNOWN

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.

Details

Lead sponsor	University of Turin, Italy
Phase	Phase 3
Status	UNKNOWN
Enrolment	198
Start date	2021-10
Completion	2025-01

Conditions

• Heart Failure

Interventions

• Intensive sodiuria-guided diuretic treatment
• Standard diuretic treatment

Primary outcomes

• Evidence of significant reduction of congestion defined as absolute reduction of at least 1 point in wet score grading of congestion after 48 hours of treatment — 48 hours
  Assessment of WET score (Gheorghiade et al, EJHF 2010)

Countries

Italy