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Recruiting NCT07750873

A Trial of CRD-4730 in HFrEF

Phase II Interventional Heart Failure With Reduced Ejection Fraction (HFrEF)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CRD-4730, Placebo.
Who it may be relevant to
Registry conditions: Heart Failure With Reduced Ejection Fraction (HFrEF). Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

Overview

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.

Interventions

  • Drug CRD-4730
    Experimental, Dose A, B and C
  • Drug Placebo
    Placebo

Primary outcome measures

  • Change from Baseline in Composite Z-Score at 24 weeks [Time frame: Baseline and Week 24]
Secondary outcome measures (11)
  • NT-proBNP biomarker [Time frame: Baseline, Week 12, and Week 24]
  • Left ventricular end-diastolic volume [Time frame: Baseline, Week 12, and Week 24]
  • Left ventricular end-diastolic volume index [Time frame: Baseline, Week 12, and Week 24]
  • Left ventricular end-systolic volume [Time frame: Baseline, Week 12, and Week 24]
  • Left ventricular end-systolic volume index [Time frame: Baseline, Week 12, and Week 24]
  • Early diastolic mitral inflow velocity (E)/early diastolic mitral annular velocity (e') ratio [Time frame: Baseline, Week 12, and Week 24]
  • Global longitudinal strain [Time frame: Baseline, Week 12, and Week 24]
  • Left atrial volume index [Time frame: Baseline, Week 12, and Week 24]
  • Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical summary score [Time frame: Baseline, Week 12 and Week 24]
  • Kansas City Cardiomyopathy Questionnaire (KCCQ) Total summary score [Time frame: Baseline, Week 12, and Week 24]
  • Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall summary score [Time frame: Baseline, Week 12, and Week 24]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Cardurion Investigative Site — Pasadena
  • Cardurion Investigative Site — Bloomfield Hills

Publications

  • Takagahara, Shuichi, et al. "Novel, Potent, and Highly Selective Calcium/Calmodulin-Dependent Protein Kinase II (CaMKII) Inhibitors Reduce Substrate Phosphorylation in Rat Hearts and Prolong Survival in a Mouse Model of Severe Heart Failure." Circulation 148.Suppl_1 (2023): A12726-A12726. https://doi.org/10.1161/circ.148.suppl_1.12726

Identifiers

NCT: NCT07750873 · CRD-4730-210

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗