Symptomatic Heart Failure With Preserved Ejection Fraction study: CK-4021586
Official title AMBER-HFpEF: Assessment of CK-4021586 in a Multi-Center, Blinded Evaluation of Safety and Tolerability Results in HFpEF
ClinicalTrials.gov ID: NCT06793371
What this study is testing
What is CK-4021586?
CK-4021586 is an investigational oral medicine being studied for symptomatic heart failure with preserved ejection fraction (HFpEF).
Also referred to as ulacamten.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find the safest dose of CK-4021586 for people with heart failure with preserved ejection fraction.
- Who it's for
- Adults who have symptomatic heart failure with preserved ejection fraction.
- What's involved
- Participants will receive the study drug and attend scheduled visits for safety checks and tests.
- Phase 2: a mid-size study of how well it works
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 85
You may be able to join if
- Males and females ≥ 40 years and ≤ 85 years of age at screening.
- Diagnosed with HF with NYHA functional class II or III.
- Screening echocardiography with LVEF ≥ 60%.
- Screening NT-proBNP ≥ 300 pg/mL for participants in sinus rhythm and ≥ 900 pg/mL for participants with comorbid atrial fibrillation or flutter.
- Body mass index \< 40 kg/m2.
You likely can't join if
- History or evidence of any other clinically significant disorder, malignancy, active infection, other condition, or disease that, in the opinion of...
- Other protocol-defined Inclusion/Exclusion criteria apply.
See the full eligibility criteria
- Males and females ≥ 40 years and ≤ 85 years of age at screening.
- Diagnosed with HF with NYHA functional class II or III.
- Screening echocardiography with LVEF ≥ 60%.
- Screening NT-proBNP ≥ 300 pg/mL for participants in sinus rhythm and ≥ 900 pg/mL for participants with comorbid atrial fibrillation or flutter.
- Body mass index \< 40 kg/m2.
- Participants on beta-blockers, angiotensin-converting enzyme (ACE)/angiotensin II receptor blocker (ARB) or angiotensin receptor/neprilysin inhibitor (ARNI), must be on stable doses for more than 30 days prior to...
- Participants on a glucagon-like peptide-1 (GLP-1) agonist must be on a stable dose for more than 24 weeks prior to screening with no anticipated plans to change dose during this study.
- 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 pose a risk to patient...
- Other protocol-defined Inclusion/Exclusion criteria apply.
The study team makes the final eligibility decision.
Where it is enrolling
- Fairhope, Alabama, United States
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- Imperial, California, United States
- Pasadena, California, United States
- San Francisco, California, United States
- Santa Maria, California, United States
- Vista, California, United States
- Hialeah, Florida, United States
- Weston, Florida, United States
- Peoria, Illinois, United States
- Boston, Massachusetts, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- Morristown, New Jersey, United States
- New York, New York, United States
- Cincinnati, Ohio, United States
- Portland, Oregon, United States
- Dallas, Texas, United States
- Houston, Texas, United States
+ 2 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Fairhope, Alabama, United States; Tucson, Arizona, United States; Little Rock, Arkansas, United States; Imperial, California, United States; Pasadena, California, United States; San Francisco, California, United States and 16 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.