Flexible vs. Fixed Diuretic Regimen in the Management of Chronic Heart Failure: A Pilot Study

NCT ID: NCT05594823

Last Updated: 2023-03-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-03
• Study Completion Date: 2023-07-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fixed - dose diuretic

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

Group Type: ACTIVE_COMPARATOR

Ambulatory heart failure management with fixed dose furosemide

Intervention Type: OTHER

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.

Flexible diuretic regimen

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

Group Type: EXPERIMENTAL

Ambulatory heart failure management with Flexible Diuretic Regimen with furosemide

Intervention Type: OTHER

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.

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Stuart Smith, MD

Cardiologist, Director of Heart Failure Services

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stuart Smith, MD

Role: PRINCIPAL_INVESTIGATOR

Western University

Locations

St. Joseph's Health Care

London, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Stuart Smith, MD

Role: CONTACT

stuart.smith@lhsc.on.ca

(519) 663-3428

Andy Jiang, MD

Role: CONTACT

andy.jiang@lhsc.on.ca

Facility Contacts

Stuart Smith, MD

Role: primary

(519) 663-3428

Other Identifiers

REDA ID: 12724

Identifier Type: -

Identifier Source: org_study_id