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)

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-525033-31-00

Enrollment

102

Registered

2026-08-14

Start date

Unknown

Completion date

Unknown

Last updated

2026-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

heart failure

Brief summary

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).

Detailed description

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.

Interventions

DRUGCRD-4730

DRUGCRD-4730-matching placebo tablet

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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).	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

—

Outcome results

None listed

Source: EU CTIS · Data processed: Aug 15, 2026