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RecruitingPhase 2

Ertugliflozin in Chronic Heart Failure

Ertugliflozin in Chronic Heart Failure: Cardio-renal and Diuretic Effects

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

Inclusion Criteria: 1. A clinical diagnosis of chronic heart failure (either systolic or diastolic) 2. Chronic daily oral loop diuretic dose use 3. eGFR ≥20 mL/min/1.73 m2 4. English speaking participants only 5. Signed informed consent Exclusion Criteria: 1. Current use or plan to initiate renal replacement therapy or ultrafiltration 2. Significant bladder dysfunction or urinary incontinence 3. Inability to comply with the serial urine collection procedures 4. Current use of a thiazide or thiazide like diuretics or use within 5 half-lives of the drug, including metolazone 5. 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 6. Prior heart transplant, critical stenotic valvular disease or complex congenital heart 7. 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 8. History of or current urosepsis or frequent urinary tract infections 9. Anemia with hemoglobin \<8g/dL (due to required phlebotomy for the study) 10. Pregnancy or breastfeeding 11. Appears unlikely or unable to participate in the required study procedures, as assessed by the study PI, study coordinator, or designee (ex: clinically-significant psychiatric, addictive, or neurological disease) 12. Inability to give written informed consent or follow study protocol 13. Severe peripheral artery disease, previous amputation, or threatened amputation 14. Life expectancy \< 3 months

Study sites (1)

CT