Sponsor study identifier
interventional
30
1 country
1
Study Start
January 3, 2023
Actual (reported)Primary Completion
July 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Heart failure is a major cause of death and hospitalization in Canada. Many of the symptoms experienced by patients with heart failure relate to having fluid accumulate in the lungs causing difficulty breathing, swelling in the legs, and an increase in weight. Thus, one of the cornerstones of managing heart failure includes the use of medications known as diuretics that target the kidneys to reduce fluid accumulation via urination. Deciding on the correct dose of this medication can be quite nuanced as under-dosing can lead to accumulation of fluid, and over-dosing can dehydrate patients and potentially result in lightheadedness/fainting and damage to the kidneys. Currently, options for prescribing diuretics for heart failure include 1) giving patients a regular, fixed dose or 2) having patients monitor their daily weight as a surrogate of their fluid status and then take a dose of diuretic based on a pre-prepared scale. The rationale behind the flexible weight-based diuretic scale is that it can potentially detect early fluid accumulation and thus possibly prevent hospitalization or ED visits, and it also avoids over-dosing and potentially dehydrating patients. Currently, it is not clear whether the flexible diuretic regimen is better than the fixed-dose regimen in preventing ED visits, hospitalizations, kidney damage, or death and as such, this pilot study will directly compare the two commonly used regimens in the management of chronic heart failure patients.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 21, 2022
Actual (reported)October 26, 2022
Actual (reported)January 3, 2023
Actual (reported)July 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Mortality and morbidity composite outcome
Time to first event of a composite outcome including: ambulatory heart failure visit (clinic or emergency department) requiring intravenous diuretic, an increase in oral diuretic dose greater than or equal to 2.5 times their baseline dose prescribed at time of randomization, or the addition of metolazone; hospitalization for heart failure and/or acute kidney injury defined as a serum creatinine \> 1.5 times from baseline at time of randomization; and all-cause death up to 90 days post-randomization
90 days
Incidence of acute kidney injury
90 days
Heart Failure Hospitalizations
90 days
All-cause Hospitalizations
90 days
Pre-determined, fixed daily dose of diuretic (furosemide)
Variable daily dose of diuretic (furosemide) determined based on a pre-specified weight-based scale.
Subjects will be given a regimen that determines a variable daily dose of diuretic (furosemide) based on daily self-measured weights as part of the standard of care ambulatory management of chronic heart failure. Follow-up will occur at 90 days with routine bloodwork to monitor renal function.
Subjects will be prescribed a fixed daily dose of diuretic (furosemide) as part of the standard of care ambulatory management of chronic heart failure. Follow-up will occur at 90 days with routine bloodwork to monitor renal function.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Treatment programme
Ambulatory heart failure management with Flexible Diuretic Regimen with furosemide
The registry describes a treatment programme. Individual components, doses and actual administration are not established by this entry.
View registry recordTreatment programme
Ambulatory heart failure management with fixed dose furosemide
The registry describes a treatment programme. Individual components, doses and actual administration are not established by this entry.
View registry recordSt. Joseph's Health Care
London, Ontario, N6A 4V2, Canada
Stuart Smith, MD
Western University
First Submitted
October 21, 2022
First Posted
October 26, 2022
Study Start
January 3, 2023
Actual (reported)Primary Completion
July 2023
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 13, 2023
Record last verified: 2023-03
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Source: ClinicalTrials.gov.
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