Incretin and Treatment With Inhibition of Sodium-glucose Cotransporter-2 Combination Insights Into Mechanisms Implicated in Congestive Heart Failure: "NATRIURETIC" Trial

Sponsor
University Health Network, Toronto
Study ID
NCT04535960
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin 25 MG + Liraglutide 1.8 MG — DRUG
    Patients will be randomized to initial therapy with empagliflozin 25mg PO daily for 6 weeks. After that, patients in the empagliflozin group will also receive liraglutide 1.8mg SC daily for additional 6 weeks.
  • Liraglutide 1.8 MG + Empagliflozin 25 MG — DRUG
    Patients will be randomized to initial therapy with liraglutide 1.8 mg SC daily, for 6 weeks. After that, patients will also receive empagliflozin 25mg PO daily for 6 weeks.

Study Details

This study aims to provide essential mechanistic insights into natriuretic and hemodynamic effects of SGLT2i and GLP-1RA agents in T2D patients. Ultimately, by obtaining physiological data in T2D patients without HF, our aims are to gain insight into how the use of this combined therapy may be used in T2D with HF in future work.

Key Dates

Start date
Jan 24, 2019
Status verified
May 2023
Primary completion
Oct 31, 2023
Completion
Oct 31, 2023

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Liraglutide
    Liraglutide Subcutaneous Total Dose 1.8mg daily for 6 weeks
  • Experimental: Empagliflozin
    Empagliflozin Tablets Total Dose 25mg daily for 6 weeks

Primary Outcome Measure

Proximal tubular natriuresis [ Time Frame: up to 12 weeks ]

Central Contacts

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