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The purpose of this study is to test the use of tolvaptan (commercial name Samsca) when given in addition to intravenous (IV) diuretics early during an episode of acute heart failure. It will be compared to a high dose of IV diuretics alone or the use of metolazone in addition to IV diuretics. The investigators are looking to see if there is improvement in the symptoms and outcomes of persons with acute heart failure.
This is a single-center, randomized trial to assess the effects of 30 mg daily of tolvaptan when given concomitantly with home dose of diuretic (Lasix equivalent) intravenously (IV) versus 5mg daily of metolazone given concomitantly with home dose of diuretic (Lasix equivalent) IV, versus 2.5 times home dose of diuretic (Lasix equivalent) IV in participants hospitalized for acutely decompensated heart failure (ADHF).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tolvaptan 30 mg and IV Lasix | Experimental | Participants admitted to the hospital and diagnosed with acutely decompensated heart failure (ADHF) will receive 30 mg of tolvaptan concomitantly with their standard dose of diuretics. |
|
| Metolazone 5mg and IV Lasix | Active Comparator | Participants admitted to the hospital and diagnosed with acutely decompensated heart failure (ADHF) will receive 5mg metolazone concomitantly with their standard dose of diuretics. |
|
| IV Lasix | Active Comparator | Participants admitted to the hospital and diagnosed with acutely decompensated heart failure (ADHF) will receive two and a half (2.5) times their standard dose of diuretics. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tolvaptan 30 mg + IV Diuretics | Drug | Participants will receive oral daily tolvaptan 30 mg concomitantly with their standard dose of intravenous (IV) diuretics for the duration of their hospitalization. |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Hospitalization Measured in Days | The number of days hospitalized until discharge. | Duration of Hospitalization (Average of Five Days) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight | The difference in body weight from hospital admission to discharge measured in kilograms. | Baseline (hospital admission), Discharge (Average of 5 Days) |
| Total Diuretic Dose |
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Inclusion Criteria:
The participant must have signs of extracellular volume expansion, defined as two or more of the following four signs or symptoms:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Divya Gupta, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | United States | ||
| Emory University Hospital |
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| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077602 | Tolvaptan |
| D004232 | Diuretics |
| D005665 | Furosemide |
| D008788 | Metolazone |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Metolazone 5 mg + IV Diuretics | Drug | Participants will receive oral daily metolazone 5 mg concomitantly with their standard dose of intravenous (IV) diuretics for the duration of their hospitalization. |
|
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| 2.5 times the Diuretics Dose | Drug | Participants will receive two and a half (2.5) times their standard dose of intravenous (IV) diuretics for the duration of their hospitalization. |
|
|
The total dose of diuretics given throughout the duration of hospitalization measured in milligrams (mg).
| Up to Five Days |
| Change in estimated glomerular filtration rate (eGFR) | The difference in eGFR from baseline (hospital admission) to discharge. | Baseline (hospital admission), Discharge (Average of 5 days) |
| Number of Days Alive | The number of days participants remain alive over thirty days after hospital discharge. | Post Hospital Discharge (30 days) |
| Rate of Re-Hospitalization | The number of participants re-hospitalized for worsening heart failure or death at 30 days. | 30 Days Post Hospitalization |
| Number of Electrolyte Imbalance Related Adverse Events | The number of adverse events due to electrolyte imbalance throughout the duration of hospitalization. | Duration of Hospitalization (Average of Five Days) |
| Number of Participants Requiring Electrolyte Repletion | The number of participants that require electrolyte repletion throughout the duration of hospitalization. | Duration of Hospitalization (Average of Five Days) |
| Change in Sodium Level | The difference in sodium levels from baseline to hospital discharge measured in milliequivalents per liter (mEqL). | Baseline (hospital admission), Discharge (Average of 5 days) |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| D045283 | Natriuretic Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D013424 | Sulfanilamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D052999 | Quinazolinones |
| D011799 | Quinazolines |