| NCT ID | NCT07750873 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Cardurion Pharmaceuticals, Inc. |
| Condition | Heart Failure With Reduced Ejection Fraction (HFrEF) |
| Study Type | INTERVENTIONAL |
| Enrollment | 525 participants |
| Start Date | 2026-07-15 |
| Primary Completion | 2028-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 525 participants in total. It began in 2026-07-15 with a primary completion date of 2028-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
CRD-4730 is a calcium/calmodulin-dependent protein kinase II (CaMKII) inhibitor. The CALIBRATE-HF trial is a Phase 2, global, multi-center, randomized, double-blind, parallel-group, placebo-controlled trial. The trial will evaluate the efficacy, safety, and tolerability of CRD-4730 in addition to guideline directed medical therapy in participants with heart failure with reduced ejection fraction (HFrEF). Participants will be randomized to 1 of 4 study groups and receive investigational study drug or placebo twice daily (BID) for 24 weeks of treatment.
Eligibility Criteria
Inclusion Criteria: * Adult male or female patient ≥ 18 years of age and ≤ 85 years of age at the time of screening. * Has a medical history supporting a diagnosis of clinical chronic heart failure (HF) syndrome with a duration of at least 8 weeks prior to the time of screening and current NYHA functional class II to III (based on investigator's assessment). * Has left ventricular ejection fraction ≤ 40% by a centrally read transthoracic echocardiogram performed during screening. * Has NT-proBNP level ≥ 600 pg/mL (70.8 pmol/L) at the time of screening. Patients in atrial fibrillation or flutter at the time of screening are required to have an NT-proBNP level of ≥ 900 pg/mL (106.4 pmol/L). * Is receiving optimized and stable guideline directed HF therapy (per applicable regional or national guidelines). Exclusion Criteria: * Has evidence of recent HF exacerbation defined by hospitalization or requirement for IV or SQ diuretics within 4 weeks of the time of screening or during the Screening Period. * Has a requirement for routine, scheduled outpatient IV infusions for HF (ie, inotropes, vasodilators, or diuretics) or routinely scheduled ultrafiltration. * Has acute coronary syndrome, unstable angina, persistent angina at rest, stroke, transient ischemic attack, cardiac, carotid or other major cardiovascular surgery, cardiac valve repair (surgical or nonsurgical) or surgical replacement, or carotid angioplasty within 8 weeks prior to screening or during the Screening Period. * Has clinical suspicion of infiltrative cardiomyopathy (eg, amyloid, sarcoid), hypertrophic cardiomyopathy (obstructive or non-obstructive), or HF secondary to severe valvular disease, active myocarditis, active pericarditis, or clinically significant congenital heart disease. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07750873 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Heart Failure With Reduced Ejection Fraction (HFrEF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07750873 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07750873 currently recruiting?
Yes, NCT07750873 is actively recruiting participants. Contact the research team at ClinicalTrialsGov@cardurion.com for enrollment information.
Where is the NCT07750873 trial being conducted?
This trial is being conducted at Pasadena, United States, Bloomfield Hills, United States.
Who is sponsoring the NCT07750873 clinical trial?
NCT07750873 is sponsored by Cardurion Pharmaceuticals, Inc.. The trial plans to enroll 525 participants.
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