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Low enrollment
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The primary objective of the study is to compare efficacy of metolazone and chlorothiazide as add-on therapy in patients refractory to loop diuretics with heart failure with a reduced ejection fraction (HFrEF). This will be a single-center randomized pilot study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metolazone | Active Comparator | Metolazone 5 mg by mouth once daily for 2 days |
|
| Chlorothiazide | Active Comparator | Chlorothiazide 500 mg IV once daily for 2 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metolazone Oral Tablet | Drug | Day 1: Metolazone 5 mg PO Day 2: Metolazone 5 mg PO |
|
| Measure | Description | Time Frame |
|---|---|---|
| Net urine output at 24 hours | Milliliters of urine output minus the oral plus intravenous intake | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Net urine output at 48 hours | Milliliters of urine output minus the oral plus IV intake | 48 hours |
| Net fluid balance over 12 hours | the net fluid balance over 12 and 24 hours prior to the addition of metolazone or chlorothiazide compared to the 12 hours after addition of the study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Electrolyte disturbances | Frequency of hypokalemia, hypomagnesemia, hyponatremia | 48 hours |
| Worsening renal function | increase in serum creatinine greater that 0.5 mg/dL from the patient's baseline value on the day of the first dose of chlorothiazide or metolazone |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia Health System | Charlottesville | Virginia | 22908 | United States |
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| Chlorothiazide Injection | Drug | Day 1: Chlorothiazide 500 mg IV Day 2: Chlorothiazide 500 mg IV |
|
|
| 24 hours |
| Net fluid balance over 24 hours | Net fluid balance over 24 hours prior to the addition of metolazone or chlorothiazide compared to the 24 hours after addition of the study drug | 48 hours |
| Weight change | Change in documented weight in kg at 48 hours after starting metolazone or chlorothiazide | 48 hours |
| 48 hours |
| Hospital length of stay | Number of days hospitalized | Assessed until hospital discharge, an average of 7 days |
| ICU length of stay | Number of days patient is located in an ICU | Assessed until hospital discharge, an average of 7 days |
| In-hospital mortality | Incidence of in-hospital mortality | Assessed until hospital discharge, an average of 7 days |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 20, 2022 | Aug 15, 2022 | 2 |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
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| ID | Term |
|---|---|
| D008788 | Metolazone |
| D002740 | Chlorothiazide |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D052999 | Quinazolinones |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001581 | Benzothiadiazines |
| D049971 | Thiazides |
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