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ERtugliflozin triAl in DIabetes With Preserved or Reduced ejeCtion FrAcTion mEchanistic Evaluation in Heart Failure

NCT03416270 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-05-06

Study results available
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Summary

This study aims to elucidate the mechanisms whereby the SGLT2i "ertugliflozin" modifies cardiorenal interactions that regulate fluid volume and neurohormonal activation in patients with type 2 diabetes and heart failure (T2D-HF).

Conditions

Interventions

DRUG

Ertugliflozin

Ertugliflozin Tablets Total Dose 15mg (10mg + 5 mg) once daily for 12 weeks

DRUG

Placebo

Placebo once daily for 12 weeks

Sponsors & Collaborators

  • University Medical Center Groningen

    collaborator OTHER

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • University of Toronto

    collaborator OTHER

  • Toronto General Hospital

    collaborator OTHER

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • David ZI Cherney, MD PhD · University Health Network, Toronto General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-28
Primary Completion
2021-04-14
Completion
2021-04-14

Countries

  • Canada
  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03416270 on ClinicalTrials.gov