NCT03509545

Brief Summary

To compare the effects of 40 mg once-daily Torsemide ER to 40 mg twice daily Furosemide on 24-hour sodium excretion.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 26, 2018

Completed
3.2 years until next milestone

Study Start

First participant enrolled

June 30, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

April 17, 2018

Last Update Submit

April 21, 2026

Conditions

Body Weight Changes

Keywords

natriuresis

Outcome Measures

Primary Outcomes (1)

  • change in 24-hour sodium excretion compared to baseline

    the difference in 24 hour sodium excretion between ER Torsemide and Furosemide

    24 hours

Secondary Outcomes (1)

  • Changes in body weight

    2 weeks

Study Arms (2)

CHF Patients: ER Torsemide 40 mg

EXPERIMENTAL

CHF patients will be given 40 mg ER Torsemide

Drug: CHF Patients: ER Torsemide 40 mg

CHF Patients: Furosemide 40 mg

ACTIVE COMPARATOR

CHF patients are on 40 mg of Furosemide

Drug: CHF Patients: Furosemide 40 mg

Interventions

CHF Patients: ER Torsemide 40 mgDRUG

ER Torsemide 40mg given once daily to CHF patients

Also known as: Demadex
CHF Patients: ER Torsemide 40 mg
CHF Patients: Furosemide 40 mgDRUG

Stable CHF patients taking twice-daily 40 mg Furosemide

Also known as: Lasix
CHF Patients: Furosemide 40 mg

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients of either gender over 18 years of age with clinical diagnosis of CHF and on a stable dose of 40 mg Furosemide.

You may not qualify if:

  • Requirement for any other diuretic, history of cardiac dysrhythmia, other concurrent cardiovascular illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Syngene International

Bangalore, Karnataka, 560099, India

Location

MeSH Terms

Conditions

Body Weight Changes

Interventions

TorsemideFurosemide

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsSulfanilamidesAniline CompoundsAmines

Study Officials

  • Anil K, MD

    Syngene

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2018

First Posted

April 26, 2018

Study Start

June 30, 2021

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

April 24, 2026

Record last verified: 2026-04

Locations

IN(1)