Empagliflozin in Heart Failure: Diuretic and Cardio-Renal Effects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-27

Study Completion Date

2019-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Acute and Chronic Empagliflozin Heart Failure

NCT05553938

Heart Failure

RECRUITING PHASE1

Empagliflozin Impact on Hemodynamics in Patients With Heart Failure

NCT03030222

Heart Failure

COMPLETED PHASE4

Effects of Empagliflozin on Diuresis and Renal Function in Patients With Acute Decompensated Heart Failure

NCT04049045

Acute Decompensated Heart Failure

COMPLETED PHASE2

Empagliflozin Versus Placebo on the Rate of Arrhythmic Events in Heart Failure Patients

NCT03271879

Heart Failure Diabetes Mellitus Arrythmia

UNKNOWN PHASE4

Empagliflozin in Heart Failure Patients With Reduced Ejection Fraction

NCT03198585

Heart Failure With Reduced Ejection Fraction

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Study Objectives

1. Study the acute/short term effect and cardio-renal mechanisms of sodium-glucose cotransporter 2 (SGLT2) inhibition in patients with heart failure.
2. Determine the effect of chronic combined SLLGT2 and loop diuretic exposure in patients with heart failure.

Primary Outcomes

1. Aim 1 (Acute): Determine if acute SGLT2 inhibition will improve the natriuretic effect of a loop diuretic compared to placebo.
2. Aim 2 (Chronic): Determine the effect of 14 days of SGLT2 inhibition on blood volume.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure Type II; Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Empagliflozin

Intervention Type DRUG

10mg empagliflozin for a 2-week period

Placebo Oral Capsule

Intervention Type DRUG

10 mg placebo for a 2-week period

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.

Group Type EXPERIMENTAL

Empagliflozin

Intervention Type DRUG

10mg empagliflozin for a 2-week period

Placebo Oral Capsule

Intervention Type DRUG

10 mg placebo for a 2-week period

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Empagliflozin

10mg empagliflozin for a 2-week period

Intervention Type DRUG

Placebo Oral Capsule

10 mg placebo for a 2-week period

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Stable HF as defined by:
* No hospitalization for \>60 days
* Stable HF medications for \>=2 weeks, and stable diuretics for 4 weeks
* Opinion of HF cardiologist that the patient is at their optimal volume status
* Chronic daily oral loop diuretic dose \>=20mg furosemide equivalents
* Diagnosis of type II diabetes
* Patient monitors blood glucose regularly at home
* eGFR \>=45 mL/min/1.73 m2
* \>=18 years old

Exclusion Criteria

* Active titration of chronic HF medications expected during the study period
* Use of a non-loop diuretic, aside from an aldosterone antagonist (\<=25mg spironolactone or \<=50mg eplerenone)
* Critical stenotic valvular disease, complex congenital heart disease, or prior heart transplant
* History of diabetic ketoacidosis, "brittle" diabetes, and/or frequent hypoglycemia or severe hypoglycemic episodes requiring emergent intervention (ER visit or EMS response, glucagon administration or forced oral carbs) in the last 6 months
* History of bladder dysfunction, incontinence, pyelonephritis, urosepsis, or frequent urinary tract infections
* Anemia (defined as hemoglobin \<8g/dL)
* Pregnancy or breastfeeding
* History of serious hypersensitivity
* Participation in another trial with an investigational drug within the 30 days prior to informed consent
* Use of another SGLT-2 inhibitor
* Appears unlikely, or unable to participate in the required study procedures, as assessed by the study PI or research RN (ex: clinically-significant psychiatric, addictive, or neurological disease)
* Inability to give written informed consent or follow study protocol

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No