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Diuretic
Immediate vs Extended Release Torsemide for Heart Failure
Phase 2
Recruiting
Led By Parta Hatamizadeh, MD, MPH
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 hours after breakfast, 6 hours after lunch, and 24 hours
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to compare the effectiveness of two different forms of a medication called torsemide in patients with stable heart failure. The study will look at whether an extended release version of the medication is better
Who is the study for?
This trial is for adults over 18 with stable chronic heart failure, who've been on a steady dose of certain diuretics. They must be able to eat a high-sodium diet and not change their heart failure meds during the study.
What is being tested?
The study compares two forms of torsemide: immediate release versus extended release, after eating a salty meal. It's double-blind and crossover, meaning patients switch between treatments without knowing which they're taking.
What are the potential side effects?
While specific side effects aren't listed here, torsemide can generally cause increased urination, dehydration symptoms, dizziness or lightheadedness due to blood pressure changes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 hours after lunch
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 hours after lunch
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cumulative Na+ excretion over 6 hours
Secondary study objectives
Fluid and Na+ excretion over the 6 hours
K+ excretion
creatinine clearance
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Extended release torsemideExperimental Treatment2 Interventions
Group II: Immediate release torsemideActive Control2 Interventions
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Who is running the clinical trial?
University of FloridaLead Sponsor
1,402 Previous Clinical Trials
764,740 Total Patients Enrolled
12 Trials studying Heart Failure
1,011 Patients Enrolled for Heart Failure
Sarfez Pharmaceuticals, Inc.Lead Sponsor
4 Previous Clinical Trials
96 Total Patients Enrolled
2 Trials studying Heart Failure
48 Patients Enrolled for Heart Failure
Parta Hatamizadeh, MD, MPHPrincipal InvestigatorUniversity of Florida
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