Comparing Natriuretic Effects of ER Torsemide to IR Torsemide in Patients With Heart Failure

Study acronym: NEXT-HF
StatusWithdrawn
PhasePhase 4
Started

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Record History

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  1. Reclassified as withdrawn (was completed) Sponsor's reason: No participants enrolled Show 6 more changesShow less
    • Enrollment target: 20 to 0
    • Primary and study completion dates: Dec 30, 2025 to Sep 16, 2026
    • Start date: May 28, 2025 to May 2025
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study description expanded, about 29 words
  2. Trial status: Recruiting to Completed
    • Study completion date changed from estimate of Mar 15, 2026 to Dec 30, 2025
    • Study description shortened, about 14 words
    • Site details revised
    v5
  3. Primary completion date changed from estimate of Dec 15, 2025 to Dec 30, 2025v4
  4. Re-verified, no change to tracked fieldsv3
  5. Secondary endpoints: details revised at 1 of 1 entry
    • Site contact updated
    • Eligibility criteria shortened, about 1 word
    v2
  6. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The primary objective of this study is to learn whether a morning dose of extended-release torsemide enhances renal sodium excretion after lunch (4-8 hours after dosing) compared to immediate-release torsemide. This is a randomized, double-blind, crossover study in patients with heart failure who are on a stable dose of a loop diuretic. The primary endpoint will be urinary sodium excretion (4-8 hours after dosing). This will be compared between the extended-release arm and the immediate-release arm to assess the efficacy of prolonged diuretic action. In addition, urinary potassium and creatinine excretion and creatinine clearance will be measured in all urine samples as the safety endpoints.
Trial Details
NCT Number NCT06995144
Lead Sponsor Sarfez Pharmaceuticals, Inc.
Conditions
(from sponsor)		 Heart Failure, Edema, Pulmonary Congestion, Fluid Overload
Related terms Edema, Heart Failure, Hypernatremia, Renal Insufficiency, Chronic
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov