A Phase 2 interventional study of CRD-4730 and Placebo in Heart Failure With Reduced Ejection Fraction (HFrEF), sponsored by Cardurion Pharmaceuticals, Inc.. Recruiting at 2 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by Cardurion Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment
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.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 525 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Cardurion Pharmaceuticals, Inc. is the lead sponsor of 12 studies on the registry; 2 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive Dose A of CRD-4730 administered orally twice daily for 24 weeks
Drug: CRD-4730
Participants will receive Dose B of CRD-4730 administered orally twice daily for 24 weeks
Drug: CRD-4730
Participants will receive Dose C of CRD-4730 administered orally twice daily for 24 weeks
Drug: CRD-4730
Participants will receive placebo administered orally twice daily for 24 weeks
Drug: Placebo
Experimental, Dose A, B and C
Placebo
Change from Baseline in Composite Z-Score at 24 weeks
Composite Z-score calculated as the average of Z-scores for the change from baseline at 24 weeks for the following 6 endpoints: NT-proBNP (log-transformed), Left ventricular end-diastolic volume index (LVEDVI), Left ventricular end-systolic volume index (LVESVI), E/e' ratio, Global longitudinal strain (GLS), Left atrial volume index (LAVI). A z-score for each component endpoint is a standardized measure with a common scale with a mean of 0 and a standard deviation of 1. Composite z-score integrates the component z-scores to assess a participant's overall response. Lower composite z-scores indicate more favorable changes from baseline, whereas higher composite z-scores indicate less favorable changes from baseline.
Time frame: Baseline and Week 24
NT-proBNP biomarker
Change in NT-proBNP (measured in pg/mL) from baseline at 12 and 24 weeks.
Time frame: Baseline, Week 12, and Week 24
Left ventricular end-diastolic volume
Change from baseline in left ventricular end-diastolic volume (LVEDV, measured in mL) at 12 and 24 weeks
Time frame: Baseline, Week 12, and Week 24
Left ventricular end-diastolic volume index
Change from baseline in left ventricular end-diastolic volume index (LVEDVI, measured in mL/m²) at 12 and 24 weeks
Time frame: Baseline, Week 12, and Week 24
Left ventricular end-systolic volume
Change from baseline in left ventricular end-systolic volume (LVESV, measured in mL) at 12 and 24 weeks
Time frame: Baseline, Week 12, and Week 24
Left ventricular end-systolic volume index
Change from baseline in left ventricular end-systolic volume index (LVESVI, measured in mL/m²) at 12 and 24 weeks
Time frame: Baseline, Week 12, and Week 24
Early diastolic mitral inflow velocity (E)/early diastolic mitral annular velocity (e') ratio
Change from baseline in early diastolic mitral inflow velocity (E)/early diastolic mitral annular velocity (e') ratio (E/e' ratio, unitless) at 12 and 24 weeks
Time frame: Baseline, Week 12, and Week 24
Global longitudinal strain
Change from baseline in global longitudinal strain (GLS, measured in %) at 12 and 24 weeks
Time frame: Baseline, Week 12, and Week 24
Left atrial volume index
Change from baseline in left atrial volume index (LAVI, measured in mL/m²) at 12 and 24 weeks
Time frame: Baseline, Week 12, and Week 24
Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical summary score
Change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical summary score (CSS) at 12 and 24 weeks. a. KCCQ, scored 0 to 100 with higher scores indicating better health.
Time frame: Baseline, Week 12 and Week 24
Kansas City Cardiomyopathy Questionnaire (KCCQ) Total summary score
Change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Total summary score (TSS) at 12 and 24 weeks. a. KCCQ scored 0 to 100 with higher scores indicating better health.
Time frame: Baseline, Week 12, and Week 24
Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall summary score
Change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall summary score (OSS) at 12 and 24 weeks. KCCQ, scored 0 to 100 with higher scores indicating better health.
Time frame: Baseline, Week 12, and Week 24
Number and percentage of participants with Treatment-emergent adverse event (TEAEs)
Number and percentage of participants with Treatment-emergent adverse event (TEAEs).
Time frame: First dose of investigational drug to Week 28 (end-of-study)
Plan to share: No
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Studies of the drug tested here: CRD-4730
Cardurion Pharmaceuticals, Inc.