Edgewise Equinox Clinical Trial
Heart Failure with Preserved Ejection Fraction (HFpEF)
A Phase 2 Clinical Study for Adults with Heart Failure with Preserved Ejection Fraction (HFpEF)
Edgewise Therapeutics is currently enrolling adults in the Phase 2 EQUINOX-HFpEF clinical trial of EDG‑15400, a new type of investigational compound called a cardiac sarcomere modulator, for the treatment of HFpEF. The study will evaluate the safety and tolerability of different doses of EDG-15400 in adults.
About Heart Failure with Preserved Ejection Fraction (HFpEF)
HFpEF is a common form of heart failure cases in the US and is on the rise. Key risk factors include advanced age, high blood pressure, kidney dysfunction, and obesity. Hospitalization rates for HFpEF are high, with approximately 20-30% of patients readmitted within 30 days, and it is associated with significant morbidity and mortality, with 5-year mortality rates around 50-60%.1
HFpEF profoundly affects patients, causing symptoms such as shortness of breath, limb swelling, fatigue, weakness, wheezing, nausea, exercise intolerance, and loss of appetite. These symptoms, which vary from mild to severe and may fluctuate, disrupt daily routines and often intensify over time, significantly diminishing quality of life. For many, the quality of life is lower than that experienced with many other chronic conditions.
At the core of HFpEF lies diastolic dysfunction, which impairs the heart’s ability to relax and fill with blood. Current HFpEF treatments may not be right for everyone. New medicines are needed to better address the challenges of HFpEF.
EQUINOX-HFpEF Study
Study Overview
This study is being conducted to learn about the safety and tolerability of an investigational drug called EDG-15400, a new type of compound called a cardiac sarcomere modulator, in adults with heart failure with preserved ejection fraction.
Talk to your doctor about participating in the EQUINOX-HFpEF study if you:
Additional criteria apply; your doctor will review them with you.
Participating in the EQUINOX-HFpEF Study
What will happen during this study?
If you qualify, you will be in the study for up to 20 weeks and have up to 6 visits. At each visit the study doctor will examine you and ask about your health, medications and side effects of EDG-15400. Depending on the visit, you will also have your blood drawn, echocardiograms (ultrasounds of your heart), ECGs (electrical tracings of your heart rhythm) and complete questionnaires.
Study Schedule
Randomized, double-blind, placebo-controlled, parallel dosing (once-daily, oral dosing for 12 weeks)
Screening Period
Follow-up Period
Screening Period
Follow-up Period
Frequently Asked Questions
Why is the EQUINOX-HFpEF study being done?
Why is the EQUINOX-HFpEF study being done?
What is a Phase 2 versus a Phase 1 trial?
What is a Phase 2 versus a Phase 1 trial?
Phase 1 studies help researchers learn about a new treatment’s safety and determine an appropriate dose, while Phase 2 studies look for signs that the treatment may help patients and continue to monitor safety.
Click here to learn more.
What is a double-blind placebo-controlled trial?
What is a double-blind placebo-controlled trial?
This study is “blinded,” which means neither you nor your study doctor will know whether you are receiving EDG-15400 or placebo. This is done to help ensure that the study results are unbiased.
In this current study design, the chances of being assigned to each group are equal, but you are twice as likely to receive EDG-15400 than placebo.
Will I be paid for being in the study? Will it cost money to be in the study?
Will I be paid for being in the study? Will it cost money to be in the study?
Yes, you will be paid for your time at each study visit completed. You may also be reimbursed for out-of-pocket expenses associated with your study-related travel.
How can I find out more information about the EQUINOX-HFpEF Study?
How can I find out more information about the EQUINOX-HFpEF Study?
For more information about the EQUINOX-HFpEF study, please visit clinicaltrials.gov, talk to your doctor, or email Edgewise Therapeutics at: hfstudies@edgewisetx.com.
EQUINOX-HFpEF Locations
Travel assistance may be available.
Learn more about this study and find a study location near you
United States Locations
Alabama Locations
Birmingham, Alabama, United States, 35211
Recruiting
Local Institution - 1
Arkansas Locations
Little Rock, Arkansas, United States, 72205
Not yet recruiting
Local Institution - 25
California Locations
Beverly Hills, California, United States, 90211
Not yet recruiting
Local Institution - 2
San Diego, California, United States, 92037
Not yet recruiting
Local Institution - 3
Vista, California, United States, 92081
Recruiting
Local Institution - 4
Florida Locations
Gainesville, Florida, United States, 32608
Not yet recruiting
Local Institution - 24
Illinois Locations
Peoria, Illinois, United States, 61636
Recruiting
Local Institution - 5
Indiana Locations
Fort Wayne, Indiana, United States, 46804
Not yet recruiting
Local Institution - 26
Indianapolis, Indiana, United States, 46260
Not yet recruiting
Local Institution - 6
Louisiana Locations
Houma, Louisiana, United States, 70360
Recruiting
Local Institution - 7
Maryland Locations
Baltimore, Maryland, United States, 21287
Not yet recruiting
Local Institution - 8
Michigan Locations
Ypsilanti, Michigan, United States, 48197
Not yet recruiting
Local Institution - 9
Minnesota Locations
Minneapolis, Minnesota, United States, 55407
Not yet recruiting
Local Institution - 28
Mississippi Locations
Jackson, Mississippi, United States, 39216
Not yet recruiting
Local Institution - 10
Missouri Locations
Kansas City, Missouri, United States, 64131
Not yet recruiting
Local Institution - 11
St Louis, Missouri, United States, 63130
Not yet recruiting
Local Institution - 12
New York Locations
New York, New York, United States, 10019
Not yet recruiting
Local Institution - 13
North Carolina Locations
Greensboro, North Carolina, United States, 27401
Not yet recruiting
Local Institution - 14
Ohio Locations
Cincinnati, Ohio, United States, 45219
Not yet recruiting
Local Institution - 15
Oklahoma Locations
Tulsa, Oklahoma, United States, 74104
Not yet recruiting
Local Institution - 27
Pennsylvania Locations
Mechanicsburg, Pennsylvania, United States, 17050
Not yet recruiting
Local Institution - 16
South Carolina Locations
Charleston, South Carolina, United States, 29425
Not yet recruiting
Local Institution - 17
Texas Locations
Dallas, Texas, United States, 75390
Not yet recruiting
Local Institution - 18
Houston, Texas, United States, 77030
Not yet recruiting
Local Institution - 19
Houston, Texas, United States, 77030
Not yet recruiting
Local Institution - 20
Houston, Texas, United States, 77030
Not yet recruiting
Local Institution - 21
Virginia Locations
Charlottesville, Virginia, United States, 22908
Not yet recruiting
Local Institution - 22
Washington Locations
Seattle, Washington, United States, 98101
Not yet recruiting
Local Institution - 23
Scroll to see more locations
About EDG-15400
EDG-15400 is an investigational drug, which means it has not been approved for use by the US Food and Drug Administration (FDA) or any other health authority. EDG-15400 is a new type of compound called a cardiac sarcomere modulator and is provided as a pill that you take every day. EDG-15400 has been given to healthy volunteers.
Contact Us
Thank you for considering the EQUINOX-HFpEF Study.
If you qualify and agree to take part in this study, there may be no medical benefit to you. The information learned from this study may benefit other people with the same condition as yours and may advance medical understanding of HFpEF.
For more information about the EQUINOX-HFpEF study:
- Talk to your doctor
- Visit clinicaltrials.gov/study/NCT07795814
- Email Edgewise Therapeutics at: hfstudies@edgewisetx.com
References
- Dunlay SM, Roger VL, Redfield MM. Epidemiology of Heart Failure with Preserved Ejection Fraction. Nat Rev Cardiol. 2017;14(10):591-602
EDG-15400 is an investigational agent that is not approved by any regulatory agency in any territory and its safety and effectiveness have not been established.
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