Recruiting

Diuretic Regimen

Sponsor:

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Code:

NCT05594823

Conditions

Heart Failure

Heart Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ambulatory heart failure management with Flexible Diuretic Regimen with furosemide

Ambulatory heart failure management with fixed dose furosemide

Study Details

Brief summary:

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.

Conditions

Heart Failure

Heart Diseases

Study ID

NCT05594823

Start date

Jan 3, 2023

Status verified date

Mar, 2023

Completion date

Jul, 2023

Anticipated

Primary completion date

Jul, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Diagnosis of heart failure, either reduced (Left ventricular ejection fraction \[LVEF\] ≤ 40%) or preserved (LVEF > 40%) ejection fraction as measured by echocardiography performed within the last 2 months
2. Prescribed and tolerating furosemide with a minimum daily dose of 40mg oral daily
3. New York Heart Association (NYHA) Class II or higher symptoms
4. NT-proBNP cutoff of ≥ 1000 pg/mL performed within 30 days prior to randomization
5. Age > 18 years
6. English speaking
7. Access to a scale and ability to weigh themselves daily and reliable telephone access

Exclusion Criteria:

1. Myocardial infarction, coronary artery bypass graft surgery, stent insertion and/or angioplasty within 14 days
2. Pregnancy
3. Inability to follow directions and self-monitor as part of a flexible diuretic regimen as discerned by the clinician
4. Allergic reaction to loop diuretics
5. Unable to provide informed consent

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Fixed - dose diuretic

Pre-determined, fixed daily dose of diuretic (furosemide)

experimental: Flexible diuretic regimen

Variable daily dose of diuretic (furosemide) determined based on a pre-specified weight-based scale.

Interventions

Ambulatory heart failure management with Flexible Diuretic Regimen with furosemide

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.

Ambulatory heart failure management with fixed dose furosemide

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.

Primary outcome measure

  • Mortality and morbidity composite outcome [ Time Frame: 90 days ]

Central Contacts and Locations

Central contacts

Locations

St. Joseph's Health Care

Recruiting

London, Ontario, Canada, N6A 4V2

Contacts

Stuart Smith, MD

(519) 663-3428

More Information

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Last update posted

Mar 13, 2023

Last verified

Mar, 2023

Keywords

  • diuretic
  • furosemide
  • flexible diuretic regimen
  • weight-based

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2023-03-13.