CRD-4730 for heart failure with reduced ejection fraction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

CALIBRATE-HF is a Phase 2, global, randomized, double-blind study evaluating the safety, tolerability, and potential effectiveness of CRD-4730 added to guideline-directed medical therapy in adults with chronic heart failure and reduced ejection fraction. Participants are assigned to one of four groups and receive the study drug or placebo twice daily for 24 weeks. The trial uses a parallel-group design and compares outcomes against placebo while monitoring standard care. Enrollment targets adults 18 to 85 with NYHA class II–III and LVEF ≤40% who meet specific NT-proBNP criteria and are on stable HF therapy. Primary analyses will focus on efficacy signals and safety in this early-phase investigation across multiple global sites.

Why it matters

Who can join: the full rules

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.

Where it's running

• Cardurion Investigative Site
  Pasadena, California, United States Recruiting
• Cardurion Investigative Site
  Bloomfield Hills, Michigan, United States Recruiting

Study contacts

• Study coordinator: Cardurion Pharmaceuticals
• Email: ClinicalTrialsGov@cardurion.com
• Phone: 617-863-8088

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Atrial Shunt to Help Heart Failure With Reduced Ejection Fraction

  This study tests whether an atrial shunt implanted after heart catheterization helps people with HFrEF when added to standard heart failure therapy.

  Recruiting Phase 2/3 Beijing Anzhen Hospital · Beijing, Beijing Municipality · NCT07820410

• Achieving Optimal Medical Therapy Through Transcatheter Mitral Repair in HFrEF

  This trial tests whether early transcatheter edge-to-edge repair (M-TEER) helps patients with HFrEF and secondary MR reach guideline-directed medical therapy faster and more completely, and whether that improves quality of life and outcomes.

  Recruiting University Medical Center Mainz · Mainz, Rhineland-Palatine · NCT07758023

• Olive oil supplementation during cardiac rehab for heart failure with reduced ejection fraction

  This study tests whether adding extra-virgin olive oil during a cardiac rehabilitation program is doable and helpful for people with HFrEF.

  Recruiting Old Dominion University · Norfolk, Virginia · NCT07644806

• Remote-guided medication up-titration for people with reduced ejection fraction heart failure

  This trial will see if telemedicine follow-up helps clinicians start and increase guideline-recommended heart failure medicines faster and more completely in adults with newly diagnosed HFrEF.

  Recruiting Azienda Unita Sanitaria Locale di Piacenza · Piacenza · NCT07518030

• Vericiguat for right‑ventricular function and heart remodeling in HFrEF

  This study will test whether adding vericiguat to usual heart‑failure treatment helps adults with stable HFrEF improve right‑ventricular function and heart remodeling over 12 months.

  Recruiting at 4 sites Phase 4 University Medical Centre Ljubljana · Izola and 3 other locations · NCT07405944

• Nerve ablation for heart failure with reduced ejection fraction using the right greater splanchnic nerve

  This early-stage, catheter-based test looks at whether ablating the right greater splanchnic nerve can help people 40 and older with HFrEF and is done in a randomized, sham-controlled setup.

  Recruiting at 7 sites Axon Therapies, Inc. · Prague and 8 other locations · NCT07403058

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.