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NCT03027960: EMPA
Empagliflozin in Heart Failure: Diuretic and Cardio-Renal Effects
Phase 1 trial testing Empagliflozin in Heart Failure in 21 participants. Completed in 1 June 2019.
14 May 2019
Quick facts
| Lead sponsor | Yale University |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 21 |
| Start date | 27 June 2017 |
| Primary completion | 14 May 2019 |
| Estimated completion | 1 June 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Empagliflozin (empagliflozin) — full drug profile →
- Placebo Oral Capsule
Conditions studied
- Heart Failure — all drugs for Heart Failure →
- Type II; Diabetes — all drugs for Type II; Diabetes →
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):
-
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 -
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 -
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 -
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:
- PubMed search for NCT03027960
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Empagliflozin
Trials testing the same drug.
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- NCT06625073 — Randomized Trial of SGLT2i in Heart Transplant Recipients · Phase 4 · recruiting
- NCT07107945 — A Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease · Phase 3 · recruiting
- NCT07214818 — SGLT2 Inhibitors in Adult Primary Nephrotic Syndrome · Phase 2, PHASE3 · active not recruiting
- NCT07180745 — Empagliflozin Versus Statins in Non-Alcoholic Fatty Liver Disease · Phase 4 · not yet recruiting
Other recruiting trials for Heart Failure
Currently open trials in the same condition.
- NCT06118983 — Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe (I-TRANSFER-HF) · NA · recruiting
- NCT07496372 — Efficacy and Safety of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) in Advanced Heart · Phase 3 · recruiting
- NCT07527156 — Prolonged Nasogastric Administration of Ketones in Decompensated Heart Failure · Phase 4 · recruiting
- NCT07263035 — Urine Sodium-Driven Diuretic Adjustment Strategy in Acute Decompensated Heart Failure · Phase 4 · recruiting
- NCT07531966 — Vascular Complications After Kidney Transplantation · recruiting
Other Yale University trials
Trials by the same sponsor.
- NCT06900998 — Pilot Study: Effects of Nimodipine on Alcohol Drinking · Phase 2 · not yet recruiting
- NCT04910984 — Developing a Chatbot to Promote HIV Testing · NA · not yet recruiting
- NCT07458087 — Accuracy of the Accuro 3S · NA · not yet recruiting
- NCT07398404 — A Multiple Health Behavior Change (MHBC) Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Pa · Phase 1, PHASE2 · not yet recruiting
- NCT07305324 — Improving Liver Fibrosis Diagnosis in Primary Care Using FibroX AI · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03027960 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Yale University
- Last refreshed: 26 June 2020
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