Ertugliflozin in Chronic Heart Failure (NCT04438213) | Clinical Trial Compass
RecruitingPhase 2
Ertugliflozin in Chronic Heart Failure
United States60 participantsStarted 2021-03-10
Plain-language summary
The purpose of this study is to determine the effects on heart failure signs and symptoms of the use of either ertugliflozin, metolazone or placebo, in conjunction with intravenous loop diuretic use in acute settings and chronic oral loop diuretic therapy.
There are two general purposes for this study. The proposed study is both larger and more rigorous than essentially all PK/PD studies that form the basis of current practice with loop diuretics as well as all studies looking at add-on thiazide therapy (current guideline-recommended adjuvant). The second is to generate a mechanistic understanding of the pleotropic cardio-renal factors with chronic therapy that differentiate ertugliflozin from traditional diuretics particularly in how they maintain reduced blood volume without the complication of over-diuresis and volume depletion.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. A clinical diagnosis of chronic heart failure (either systolic or diastolic)
✓. Chronic daily oral loop diuretic dose use
✓. eGFR ≥20 mL/min/1.73 m2
✓. English speaking participants only
✓. Signed informed consent
Exclusion criteria
✕. Current use or plan to initiate renal replacement therapy or ultrafiltration
✕. Significant bladder dysfunction or urinary incontinence
✕. Inability to comply with the serial urine collection procedures
✕. Current use of a thiazide or thiazide like diuretics or use within 5 half-lives of the drug, including metolazone
✕. Current use of a SGLT-2 inhibitor, or in the treating provider's judgement, contraindication to be withdrawn from current use of an SGLT-2 inhibitor
What they're measuring
1
Change from baseline to day 7 of plasma volume by add-on to loop diuretic therapy
Timeframe: 7 days
2
Change from baseline to 6 weeks of plasma volume by add-on to loop diuretic therapy
Timeframe: 6 weeks
3
Natriuretic effect of adjuvant to loop diuretic therapy
✕. History of type 1 diabetes, diabetic ketoacidosis, "brittle" diabetes or frequent hypoglycemia or severe hypoglycemic episodes requiring emergent intervention (ER visit or EMS response, glucagon administration or forced oral carbs) in the last 3 months
✕. History of or current urosepsis or frequent urinary tract infections