| Trial ID: | L1760 |
| Source ID: | NCT03226457
|
| Associated Drug: |
Empagliflozin 25mg
|
| Title: |
SGLT2 Inhibition in Combination With Diuretics in Heart Failure
|
| Acronym: |
RECEDE-CHF
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT03226457/results
|
| Conditions: |
Heart Failure|Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Empagliflozin 25mg|DRUG: Placebo oral capsule|DRUG: Frusemide
|
| Outcome Measures: |
Primary: The Effect of Empagliflozin Versus Placebo on the Change in Urine Output., Change from urinary volume from baseline (mls)., Change from baseline to 6 weeks | Secondary: The Effect of Empagliflozin Versus Placebo on the Change in Urinary Sodium Excretion., The effect of empagliflozin versus placebo on the change in urinary sodium excretion: change in fractional urinary sodium excretion from baseline (%)., Change from baseline to 6 weeks|Number of Participants With a Change in CKD Category as Dictated by the Glomerular Filtration Rate, The effect of empagliflozin versus placebo on the change in glomerular filtration rate: Change in estimated glomerular filtration rate from baseline (ml/min/1.73m2). Data was recorded as a persistent reduction in CKD category in the empagliflozin group versus placebo, From baseline to 6 weeks|The Effect of Empagliflozin Versus Placebo on the Change in Serum Creatinine., Change in serum creatinine from baseline (mmol/L)., Change from baseline to 6 weeks|The Effect of Empagliflozin Versus Placebo on the Change to Urinary Protein/Creatinine Ratio., The effect of empagliflozin versus placebo on the change to urinary protein/creatinine ratio: Change in urinary protein/creatinine ratio from baseline (mg/mmol)., Change from baseline to 6 weeks|The Effect of Empagliflozin Versus Placebo on the Change to Urinary Albumin/Creatinine Ratio., The effect of empagliflozin versus placebo on the change to urinary albumin/creatinine ratio: Change in urinary albumin/creatinine ratio from baseline (mg/mmol)., Change from baseline to 6 weeks|The Effect of Empagliflozin Versus Placebo on the Change to the Renal Biomarker, Cystatin C., The effect of empagliflozin versus placebo on the change to the renal biomarker, cystatin C: Change in Cystatin C from baseline (ng/ml)., Change from baseline to 6 weeks
|
| Sponsor/Collaborators: |
Sponsor: University of Dundee | Collaborators: British Heart Foundation
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
23
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2017-12-11
|
| Completion Date: |
2019-01-09
|
| Results First Posted: |
2021-06-30
|
| Last Update Posted: |
2021-06-30
|
| Locations: |
University of Dundee, Ninewells Hospital and Medical School, Dundee, Angus, DD1 9SY, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT03226457
|
