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

NCT05594823 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: REDA ID: 12724
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

diuretic; furosemide; flexible diuretic regimen; weight-based

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Incidence of acute kidney injury

  90 days

• Heart Failure Hospitalizations

  90 days

• All-cause Hospitalizations

  90 days

Study Arms (2)

Fixed - dose diuretic

ACTIVE COMPARATOR

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

Other: Ambulatory heart failure management with fixed dose furosemide

Flexible diuretic regimen

EXPERIMENTAL

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

Other: Ambulatory heart failure management with Flexible Diuretic Regimen with furosemide

Interventions

Ambulatory heart failure management with Flexible Diuretic Regimen with furosemide 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.

Flexible diuretic regimen

Ambulatory heart failure management with fixed dose furosemide 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.

Fixed - dose diuretic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Prescribed and tolerating furosemide with a minimum daily dose of 40mg oral daily
• New York Heart Association (NYHA) Class II or higher symptoms
• NT-proBNP cutoff of ≥ 1000 pg/mL performed within 30 days prior to randomization
• Age \> 18 years
• English speaking
• Access to a scale and ability to weigh themselves daily and reliable telephone access

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

St. Joseph's Health Care

London, Ontario, N6A 4V2, Canada

RECRUITING

MeSH Terms

Conditions

Heart Failure; Heart Diseases

Interventions

Furosemide

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds

Study Officials

• Stuart Smith, MD

  Western University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stuart Smith, MD

CONTACT

(519) 663-3428; stuart.smith@lhsc.on.ca

Andy Jiang, MD

CONTACT

andy.jiang@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist, Director of Heart Failure Services

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: October 26, 2022
• Study Start: January 3, 2023
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: March 13, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)