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Diuretic

Torsemide for Heart Failure (EXTOR-HF Trial)

Phase 4

Recruiting

Led By Nayle A Ancares, MD

Research Sponsored by Sarfez Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No anticipated changes in HF medications during the study period

Premenopausal women of child-bearing potential have a negative pregnancy test prior to beginning of the study and agree to use effective contraceptive methods during the study period

Must not have

Requirement for a diuretic other than furosemide, bumetanide or torsemide except for spironolactone, eplerenone, finerenone, or SGLT2 inhibitors, at randomization and during the study

Severe/symptomatic lung disease or respiratory symptoms distinct from HF

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 hours after lunch

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

No Placebo-Only Group

Summary

This trial is looking at patients with stable heart failure who are taking a specific type of medication. They will switch to a different medication for a week and then come to the clinic to receive a single dose

Who is the study for?

This trial is for men and women over 18 with stable heart failure, who have been on loop diuretics like furosemide. They must not expect to change their heart failure meds during the study and agree to use birth control if applicable. It's not for those with recent severe cardiac or kidney events, uncontrolled diabetes or hypertension, certain lung diseases, urinary issues, very low kidney function, a history of specific heart conditions, or breastfeeding women.

What is being tested?

The study tests immediate release (IR) versus extended release (ER) Torsemide in patients with stable heart failure already taking loop diuretics. Participants will switch from their current medication to IR/ER Torsemide for one week and then receive a single dose at the site where sodium excretion post-dosing and after a high salt meal will be measured.

What are the potential side effects?

While the trial description does not specify side effects, generally torsemide can cause dehydration symptoms due to increased urination; electrolyte imbalances like low potassium; dizziness; headache; gastrointestinal disturbances such as nausea or constipation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I don't expect to change my heart failure medications soon.

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I am a woman who can have children, not pregnant, and will use birth control during the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking diuretics other than spironolactone, eplerenone, finerenone, or SGLT2 inhibitors.

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I have severe lung problems not related to heart failure.

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My diabetes or high blood pressure is not under control.

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My kidney function is severely reduced.

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I am currently breastfeeding.

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I have trouble controlling my bladder or fully emptying it.

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I have had sudden lung swelling or heart issues due to amyloid.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 hours after breakfast, 6 hours after lunch, and 24 hours]

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 hours after breakfast, 6 hours after lunch, and 24 hours]

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 hours after breakfast, 6 hours after lunch, and 24 hours] for reporting.

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

Creatinine clearance

Fluid and Na+ excretion over the 6 hours

K+ excretion

Side effects data

From undefined Phase 1 trial • 23 Patients • NCT01276288

Headache

100%

80%

60%

40%

20%

Study treatment Arm

Empagliflozin (Empa)

Hydrochlorothiazide (HCT)

Torasemide (TOR)

Empa+ HCT

Empa + TOR

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 Treatment1 Intervention

Drug: Extended release torsemide 24 mg tablet. Subjects will receive oral dose of 24 mg extended release torsemide tablet and a placebo of 20 mg immediate release torsemide.

Group II: Immediate release torsemideActive Control1 Intervention

Drug: Immediate release torsemide 20 mg tablet. Subjects will receive oral dose of 20 mg of immediate release torsemide and a placebo of 24 mg extended release torsemide.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

torsemide

2012

Completed Phase 1

~150

0 / 9Eligibility criteria met