| Trial ID: | L5881 |
| Source ID: | NCT03027960
|
| Associated Drug: |
Empagliflozin
|
| Title: |
Empagliflozin in Heart Failure: Diuretic and Cardio-Renal Effects
|
| Acronym: |
EMPA
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Heart Failure|Type II; Diabetes
|
| Interventions: |
DRUG: Empagliflozin|DRUG: Placebo Oral Capsule
|
| Outcome Measures: |
Primary: urine sodium concentrations via ion selective electrodes, Determine if acute SGLT2 inhibition will improve the natriuretic effect of a loop diuretic compared to placebo. Measuring the natriuretic effect of a loop diuretic (placebo v acute SGLT2 inhibition) via urine sodium output., 36 days | Secondary: blood volume, Determine the effect of 14 days of SGLT2 inhibition on blood volume. Daxor Blood Volume Sample Collection 1. Volumex Injection: The Volumex tracer (radiolabeled albumin) is injected as an intravenous bolus (IV-push). (As soon as the tracer injection begins, a stopwatch is started and never zeroed out. Running times are used for the entire procedure). 2. Serial Blood Collection A series of 5 post-Volumex blood samples is collected, after tracer injection, allowing for complete mixing in the bloodstream. 3. Sample Timing: Samples are ideally spaced \~6 minutes apart, and are collected approximately 12, 18, 24, 30 and 36 minutes after Volumex administration., 14 days
|
| Sponsor/Collaborators: |
Sponsor: Yale University | Collaborators: Boehringer Ingelheim
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
21
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
|
| Start Date: |
2017-06-27
|
| Completion Date: |
2019-06-01
|
| Results First Posted: |
|
| Last Update Posted: |
2020-06-26
|
| Locations: |
Yale New Haven Hospital, New Haven, Connecticut, 06511, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03027960
|
