Empagliflozin in Heart Failure: Diuretic and Cardio-Renal Effects
EMPA
EMPA
Sponsor study identifier
interventional
21
1 country
1
Study Start
June 27, 2017
Actual (reported)Primary Completion
May 14, 2019
Actual (reported)Study Completion
June 1, 2019
Actual (reported)The investigators propose a small pilot proof of concept study to not only prove the existence of, but also probe the mechanisms underlying cardio-renal effects of empagliflozin in patients with heart failure. The investigators propose a 50 patient randomized, double-blind, placebo-controlled crossover study with patients with stable HF, type II diabetes and an eGFR \>45ml/min/1.73 m2 who are chronically receiving loop diuretics.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 1, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 17, 2017
Actual (reported)January 23, 2017
Actual (reported)June 27, 2017
Actual (reported)May 14, 2019
Actual (reported)June 1, 2019
Actual (reported)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
blood volume
14 days
Patients are randomized upon enrollment to determine whether they take empagliflozin or the matched placebo during the first 2-week treatment phase of the study. All patients then undergo a 2-week "washout period" before crossing over to the alternate therapy.
Patients are randomized upon enrollment to determine whether they take empagliflozin or the matched placebo during the first 2-week treatment phase of the study. All patients then undergo a 2-week "washout period" before crossing over to the alternate therapy.
10mg empagliflozin for a 2-week period
10 mg placebo for a 2-week period
Yale New Haven Hospital
New Haven, Connecticut, 06511, United States
Rao VS, Ivey-Miranda JB, Cox ZL, Moreno-Villagomez J, Maulion C, Bellumkonda L, Chang J, Field MP, Wiederin DR, Butler J, Collins SP, Turner JM, Wilson FP, Inzucchi SE, Wilcox CS, Ellison DH, Testani JM. Empagliflozin in Heart Failure: Regional Nephron Sodium Handling Effects. J Am Soc Nephrol. 2024 Feb 1;35(2):189-201. doi: 10.1681/ASN.0000000000000269. Epub 2023 Dec 11.
Griffin M, Rao VS, Ivey-Miranda J, Fleming J, Mahoney D, Maulion C, Suda N, Siwakoti K, Ahmad T, Jacoby D, Riello R, Bellumkonda L, Cox Z, Collins S, Jeon S, Turner JM, Wilson FP, Butler J, Inzucchi SE, Testani JM. Empagliflozin in Heart Failure: Diuretic and Cardiorenal Effects. Circulation. 2020 Sep 15;142(11):1028-1039. doi: 10.1161/CIRCULATIONAHA.120.045691. Epub 2020 May 15.
Jeffrey Testani, MD
Yale University
21 participants (actual enrollment reported by the registry).
First Submitted
January 17, 2017
First Posted
January 23, 2017
Study Start
June 27, 2017
Actual (reported)Sodium-glucose Co Transporter 2 (sGLT2) Inhibitor and Endogenous Ketone Production
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
May 14, 2019
Actual (reported)Study Completion
June 1, 2019
Actual (reported)Last Updated
June 26, 2020
Record last verified: 2020-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: