Trial intelligence / Profile preview

Spironolactone for AF Maintenance in Hypertension (SPONSoR)

NCT06204640Phase 3

Key facts

Status
Not yet recruiting
Start
Mar 2024
Primary completion
Jan 2028
Sponsor
CHU Caen Normandie
Modality
Small Molecules
Conditions
Atrial fibrillation (AFib)
01

Overview

Phase 3, randomised, open-label trial in Atrial fibrillation (AFib) comparing Spironolactone with Standard of Care (2 arms). Primary endpoint: Atrial Fibrillation Recurrence at 12 months. Planned start Mar 2024; status: not yet recruiting.

02

Design

2 arms
Study design
RandomizedOpen-label
  • Spironolactone

    Spironolactone + Standard of Care

  • Standard of Care

    Standard of Care alone

03

Endpoints

Primary

  • Atrial Fibrillation Recurrence

Secondary

  • Symptomatic Atrial Fibrillation Recurrence

  • Delay of Atrial Fibrillation Recurrence

  • Atrial Fibrillation Burden

  • Major Adverse Cardiovascular Events

  • Cerebral/Systemic Thrombo-embolic and Bleeding Events

  • Atrial Fibrillation Heart Rate

  • Blood Pressure

  • Safety of Spironolactone

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