Status:
RECRUITING
Comparing Natriuretic Effects of ER Torsemide to IR Torsemide in Patients With Heart Failure
Lead Sponsor:
Sarfez Pharmaceuticals, Inc.
Conditions:
Heart Failure
Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 ...
Detailed Description
Research Plan Study Design This is a double-blind, double-dummy, two-period, two-arm, randomized, crossover study. Initial Study Procedures Identification of Participants: Patients with a known hi...
Eligibility Criteria
Inclusion
- Age: 18 years or older.
- Informed Consent: Willing and able to sign the informed consent form.
- Stable Chronic HF: A clinical diagnosis of chronic heart failure considered stable by the patient's cardiologist/physician or another experienced clinician for at least one month prior to randomization.
- Current Diuretic Therapy: Receiving an oral dose of 20 mg to 80 mg daily of furosemide, or 10 mg to 40 mg daily dose of torsemide, or 1 mg to 4 mg daily dose of bumetanide, for about 30 days prior to randomization.
- Stable HF Medications: No anticipated changes in HF medications during the study period.
- Female Participants: Premenopausal women of childbearing potential must have a negative pregnancy test prior to study initiation and agree to use effective contraceptive methods throughout the study period.
Exclusion
- Other Diuretics: Requirement for a diuretic other than furosemide, bumetanide, or torsemide (except for spironolactone, eplerenone, finerenone, or SGLT2 inhibitors) at randomization or during the study.
- Recent Cardiovascular Events: Myocardial infarction, stroke, transient ischemic attack, acute kidney injury, or acute HF requiring hospitalization within 30 days prior to randomization.
- Severe Lung Disease: Severe or symptomatic lung disease or respiratory symptoms distinct from HF.
- Urinary Issues: History of urinary incontinence, or inability to empty the bladder.
- Uncontrolled Comorbidities: Uncontrolled diabetes mellitus or hypertension.
- Renal Dysfunction: Estimated GFR \< 30 ml/min/1.72m².
- Cardiac Conditions: History of flash pulmonary edema or amyloid cardiomyopathy.
- Breastfeeding: Female participants who are breastfeeding.
- Recent Participation in Clinical Trials: Participation in another clinical trial within the last three months prior to randomization.
- Requirements for treatment with a non-steroidal anti-inflammatory drug (except for Aspirin up to 200 mg as PRN daily).
- Serum potassium concentration \<3.5 or \>5.5 mmol/L.
Key Trial Info
Start Date :
May 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 15 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06995144
Start Date
May 28 2025
End Date
March 15 2026
Last Update
January 8 2026
Active Locations (1)
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1
Future Life Clinical Trials
Miami, Florida, United States, 33169