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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fixed - dose diuretic | Active Comparator | Pre-determined, fixed daily dose of diuretic (furosemide) |
|
| Flexible diuretic regimen | Experimental | Variable daily dose of diuretic (furosemide) determined based on a pre-specified weight-based scale. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of acute kidney injury | Rate of acute kidney injury defined as a serum creatinine increase of >1.5 times from baseline at 90 days from randomization | 90 days |
| Heart Failure Hospitalizations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stuart Smith, MD | Contact | (519) 663-3428 | stuart.smith@lhsc.on.ca | |
| Andy Jiang, MD | Contact | andy.jiang@lhsc.on.ca |
| Name | Affiliation | Role |
|---|---|---|
| Stuart Smith, MD | Western University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Health Care | Recruiting | London | Ontario | N6A 4V2 | Canada |
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|
| 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. |
|
Total number of hospitalizations due to heart failure (first and recurrent) during the 90 days post-randomization
| 90 days |
| All-cause Hospitalizations | Total number of hospitalizations for any cause during the 90 days post-randomization | 90 days |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D005665 | Furosemide |
| ID | Term |
|---|---|
| D013424 | Sulfanilamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
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