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| Name | Class |
|---|---|
| Boehringer Ingelheim | INDUSTRY |
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A proof-of-concept placebo-controlled trial to explore the acute and 14-day effects of empagliflozin on natriuresis and total body water in patients with cirrhosis and ascites. We will additionally investigate its effect on neurohumoral activation, and renal hemodynamics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empagliflozin | Active Comparator | Empagliflozin vs placebo for 14 days, followed by 14 day washout period, before crossing over to the alternate drug. |
|
| Placebo | Placebo Comparator | Empagliflozin vs placebo for 14 days, followed by 14 day washout period, before crossing over to the alternate drug. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin 10 MG | Drug | Participants will be randomized to Empagliflozin 10 mg or placebo for 14 days. A 14 day washout period follows and then participants is crossed over to the alternate treatment for 14 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in FENa with administration of study drug (10 mg empagliflozin vs. identical placebo) | Change in fractional excretion of sodium with administration of study drug (10 mg empagliflozin vs. identical placebo) | 14 days |
| Change in total body water (TBW) before and after a 14-day course of study drug | Change in total body water (TBW) before and after a 14-day course of study drug (10 mg/day empagliflozin vs. identical placebo) | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in renal blood flow before and after administration of study drug | Change in renal blood flow (RBF) as determined by PAH clearance, before and after the acute administration of study drug ((RPF assessed using ancillary protocol on page 31) | Baseline to Hour 6 |
| Change in plasma renin activity,total renin, aldosterone, norepinephrine and copeptin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Veena Rao, PHD | Contact | 2037373571 | veena.s.rao@yale.edu | |
| Kara Otis | Contact | 2037373571 | kara.otis@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Testani, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | Recruiting | New Haven | Connecticut | 06510 | United States |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D017093 | Liver Failure |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
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Proof of concept, randomized, cross over, phase II double-blind placebo-controlled study
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double-blind placebo-controlled study
| Matching Placebo | Drug | Participants will be randomized to Empagliflozin 10 mg or placebo for 14 days. A 14 day washout period follows and then participants is crossed over to the alternate treatment for 14 days. |
|
Change in plasma renin activity (PRA), total renin, aldosterone, norepinephrine and copeptin before and after a 14-day course of study drug |
| 14 days |
| D004066 | Digestive System Diseases |