A Study of EDG-15400 in Adults With Heart Failure With Preserved Ejection Fraction (EQUINOX-HFpEF)
Heart Failure With Preserved Ejection Fraction
What This Study Is About
Who Can Participate
- Males and nonpregnant females, ages ≥30 to \<85 years of age at screening
- Body weight ≥ 45 kg, BMI \< 40
- LVEF ≥ 50%
- Diagnosed with Heart Failure per American Heart Association (AHA)/American College of Cardiology (ACC)/Heart Failure Society of America (HFSA) Guidelines for the Management of Heart Failure
- New York Heart Association (NYHA) functional class II or III
- +2 more...
- Known diagnosis of hypertrophic cardiomyopathy (HCM)
- Known or suspected infiltrative or storage disorder (e.g., Noonan syndrome, Fabry disease, amyloidosis)
- Hospitalization for any reason within 60 days prior to Screening
- Moderate or greater interstitial lung disease (ILD) or ILD requiring chronic supplemental O2 therapy
- Severe or greater chronic obstructive pulmonary disease (COPD) or COPD requiring chronic supplementary O2 therapy
- History or evidence of any other clinically significant disorder, malignancy, active infection, other condition, or disease that, in the opinion of the Investigator or the Medical Monitor, would be an alternative explanation for heart failure symptoms (e.g., significant lung disease, anemia) and/or would pose a risk to patient safety or interfere with the study evaluation, procedures, or completion
- Age 85+ years
View Full Eligibility Criteria
Inclusion Criteria: * Males and nonpregnant females, ages ≥30 to \<85 years of age at screening * Body weight ≥ 45 kg, BMI \< 40 * LVEF ≥ 50% * Diagnosed with Heart Failure per American Heart Association (AHA)/American College of Cardiology (ACC)/Heart Failure Society of America (HFSA) Guidelines for the Management of Heart Failure * New York Heart Association (NYHA) functional class II or III * If receiving Guideline-directed Medical Therapy, must be on stable doses * Participants receiving a GLP-1 agonist prior to Screening must have no anticipated plans to change dose during the study Exclusion Criteria: * Known diagnosis of hypertrophic cardiomyopathy (HCM) * Known or suspected infiltrative or storage disorder (e.g., Noonan syndrome, Fabry disease, amyloidosis) * Moderate or greater interstitial lung disease (ILD) or ILD requiring chronic supplemental O2 therapy * Severe or greater chronic obstructive pulmonary disease (COPD) or COPD requiring chronic supplementary O2 therapy * Hospitalization for any reason within 60 days prior to Screening * History or evidence of any other clinically significant disorder, malignancy, active infection, other condition, or disease that, in the opinion of the Investigator or the Medical Monitor, would be an alternative explanation for heart failure symptoms (e.g., significant lung disease, anemia) and/or would pose a risk to patient safety or interfere with the study evaluation, procedures, or completion
Important: This is a summary. The final determination of eligibility will be made by the trial coordinator after reviewing your complete medical history.
Study Locations
Show all 25 locations
Contact
Study Director: Medical Director, Edgewise Therapeutics, Inc.
Experimental Treatment
This trial is testing a new treatment. Results are not guaranteed. Talk to your doctor before applying.
Your information will be sent to the study coordinator for review.