Empagliflozin in Heart Failure: Diuretic and Cardio-Renal Effects

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT03027960
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Empagliflozin — DRUG
    10mg empagliflozin for a 2-week period
  • Placebo Oral Capsule — DRUG
    10 mg placebo for a 2-week period

Study Details

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.

Key Dates

Start date
Jun 27, 2017
Status verified
Jun 2020
Primary completion
May 14, 2019
Completion
Jun 1, 2019

Study Design

Enrollment
21 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Placebo, then empagliflozin
    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.
  • Experimental: Empagliflozin, then Placebo
    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.

Primary Outcome Measure

urine sodium concentrations via ion selective electrodes [ Time Frame: 36 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Yale New Haven HospitalNew HavenConnecticut06511-

Find similar trials in New Haven, CT

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Yale New Haven Hospital· New Haven, CT

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