RecruitingPhase 2

A Trial of CRD-4730 in HFrEF

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of CRD-4730 in Patients With Heart Failure With Reduced Ejection Fraction (HFrEF)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 24 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests CRD-4730 added to usual heart failure medicines in adults whose hearts do not pump well. It will check how well the drug works, its safety, and side effects. Participants take the study drug or a placebo (a pill with no active drug) twice a day for 24 weeks.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are 18 to 85 years old.
  • Have had heart failure for at least 8 weeks, with symptoms that mildly or greatly limit physical activity (NYHA class II or III).
  • A heart ultrasound at screening shows the heart’s main pumping chamber pumps out 40% or less of its blood with each beat.
  • Have an NT-proBNP blood test level of at least 600 pg/mL. This marker of heart strain must be at least 900 pg/mL if you have atrial fibrillation or flutter, types of abnormal heartbeat.
  • Are taking recommended heart failure medicines, with treatment adjusted for your needs and kept stable.

Who can't join

  • Had worsening heart failure needing a hospital stay or water-removing medicine through a vein or under the skin within 4 weeks before screening or during screening.
  • Need regular clinic treatments through a vein for heart failure, or regular treatments that filter extra fluid from the blood.
  • Had a sudden heart blood-flow problem, new or worsening heart-related chest pain, ongoing chest pain at rest, a stroke, or a mini-stroke within 8 weeks before screening or during screening.
  • Had major heart or blood vessel surgery, a heart valve repair or replacement, or a procedure to open a neck artery within 8 weeks before screening or during screening.
  • May have heart muscle disease caused by abnormal buildup in the heart, or have an abnormally thick heart muscle.
  • Have heart failure caused by severe heart valve disease, active swelling of the heart muscle or its outer sac, or a major heart problem present since birth.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (2)

CA

MI