Clinical trial NCT05594823: Flexible vs. Fixed Diuretic Regimen in the Management of Chronic Heart Failure: A Pilot Study
Official title: Flexible vs. Fixed Diuretic Regimen in the Management of Chronic Heart Failure: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Heart Failure
Heart Diseases
Keywords: diuretic
furosemide
flexible diuretic regimen
weight-based
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2022-10-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Mortality and morbidity composite outcome
timeFrame: 90 days
Secondary outcomes:
measure: Incidence of acute kidney injury
timeFrame: 90 days
measure: Heart Failure Hospitalizations
timeFrame: 90 days
measure: All-cause Hospitalizations
timeFrame: 90 days
Other outcomes:
Locations:
city: London
country: Canada
facility: St. Joseph's Health Care
state: Ontario
Study officials:
affiliation: Western University
name: Stuart Smith, MD
role: PRINCIPAL_INVESTIGATOR
References: