Last reviewed · How we verify

NCT03027960: EMPA

Empagliflozin in Heart Failure: Diuretic and Cardio-Renal Effects

Completed Phase 1 Last updated 26 June 2020
What this trial tests

Phase 1 trial testing Empagliflozin in Heart Failure in 21 participants. Completed in 1 June 2019.

Timeline
27 June 2017
Primary endpoint
14 May 2019
1 June 2019

Quick facts

Lead sponsorYale University
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingdouble
Primary purposetreatment
Enrollment21
Start date27 June 2017
Primary completion14 May 2019
Estimated completion1 June 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Yale University

Who can join

18 and older, any sex, with Heart Failure or Type II; Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Sodium Glucose Cotransporter-2 Inhibition in Heart Failure: Potential Mechanisms, Clinical Applications, and Summary of Clinical Trials.
    Lytvyn Y, Bjornstad P, Udell JA, Lovshin JA, et al · · 2017 · cited 330× · PMID 29061576 · DOI 10.1161/circulationaha.117.030012
  2. Empagliflozin in Heart Failure: Diuretic and Cardiorenal Effects.
    Griffin M, Rao VS, Ivey-Miranda J, Fleming J, et al · · 2020 · cited 312× · PMID 32410463 · DOI 10.1161/circulationaha.120.045691
  3. Empagliflozin in Heart Failure: Regional Nephron Sodium Handling Effects.
    Rao VS, Ivey-Miranda JB, Cox ZL, Moreno-Villagomez J, et al · · 2024 · cited 26× · PMID 38073038 · DOI 10.1681/asn.0000000000000269
  4. SAVOR-TIMI to DECLARE-TIMI: A Review on Cardiovascular Outcome Trials of Incretin-modulators and Gliflozins.
    Singh AK, Singh R. · · 2019 · cited 2× · PMID 31161099 · DOI 10.4103/ijem.ijem_12_19

Verify or expand the search:

Other trials of Empagliflozin

Trials testing the same drug.

Other recruiting trials for Heart Failure

Currently open trials in the same condition.

Other Yale University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03027960.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing