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Diuretic

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

Study 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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~6 hours after lunch
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 hours after lunch for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cumulative Na+ excretion over 6 hours
Secondary outcome measures
Fluid and Na+ excretion over the 6 hours
K+ excretion
creatinine clearance

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Extended release torsemideExperimental Treatment2 Interventions
Group II: Immediate release torsemideActive Control2 Interventions

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,341 Previous Clinical Trials
715,620 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the safety profile of extended-release torsemide in individuals?

"The safety assessment for Extended release torsemide is rated 2 by our team at Power, reflecting the Phase 2 trial status where some safety data exists but no efficacy data has been reported."

Answered by AI

What is the upper limit for participant enrollment in this research investigation?

"Indeed, as per the details on clinicaltrials.gov, this trial is actively in search of participants. The study was first made public on March 1st, 2024 and underwent its most recent revision on March 11th, 2024. They aim to recruit a total of 26 individuals from one designated site."

Answered by AI

Are participants currently being enrolled in this clinical trial?

"Indeed, as per clinicaltrials.gov data, this investigation is actively seeking eligible individuals. The trial was initially posted on March 1st, 2024 and last modified on March 11th, 2024. Enrollment of 26 participants is planned at a single site."

Answered by AI

Does this study include individuals who are older than 55 years of age?

"To be considered for this research endeavor, individuals must fall within the age range of 18 to 100. There are separate trials available specifically catering to those under 18 years old and others tailored for participants above 65 years of age, totaling to a count of 24 and 745 respective trials."

Answered by AI

Which individuals meet the criteria for participation in this medical study?

"This research seeks 26 individuals aged between 18 to 100 with current heart failure. Interested participants must adhere to the following requirements: Capable of adhering to a diet containing around 3 grams of Na+ daily, willing and able to provide informed consent, no expected modifications in HF medications throughout the study duration, male or female above age 18 years old, an established clinical diagnosis of stable chronic HF as determined by the patient's cardiologist/physician within one month before randomization, maintaining a stable furosemide dose equivalent to either 40mg or 80mg per day (or similar doses of torsemide"

Answered by AI

Who else is applying?

What site did they apply to?
Division of Nephrology, Hypertension & Renal Transplantation, University of Florida
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Immediate Release Versus Extended Release Torsemide After Salty Meal
2024. "Immediate Release Versus Extended Release Torsemide After Salty Meal". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06176794.
~17 spots leftby Aug 2025
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