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) (CALIBRATE-HF)

Condition studied

heart failure

Investigational medicinal product(s)

Eligibility

Primary endpoint

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).

Endpoint detail

Change in NT-proBNP from baseline at 12 and 24 weeks, Change in echocardiography parameters from baseline at 12 and 24 weeks: − LVEDV, LVEDVI − LVESV, LVESVI − E/e′ ratio − GLS − LAVI, Change in Kansas City cardiomyopathy questionnaire (KCCQ) Clinical summary score (CSS), Total symptom score (TSS), and Overall summary score (OSS) from baseline at 12 and 24 weeks., The number and percentage of participants with Treatment-emergent adverse event (TEAEs)., Changes in clinical laboratory results, vital signs, 12-lead Electrocardiogram (ECG) data.