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NCT Number: NCT07750873

A Trial of CRD-4730 in HFrEF

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.

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Key information

Conditions

Heart Failure With Reduced Ejection Fraction (HFrEF) Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cardurion Investigative Site, Pasadena, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CRD-4730

Drug

Experimental, Dose A, B and C

Placebo

Drug

Placebo

Primary outcomes

  1. Change from Baseline in Composite Z-Score at 24 weeks

    Time frame: Baseline and Week 24

    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.

Secondary outcomes

  1. NT-proBNP biomarker

    Time frame: Baseline, Week 12, and Week 24

    Change in NT-proBNP (measured in pg/mL) from baseline at 12 and 24 weeks.

  2. Left ventricular end-diastolic volume

    Time frame: Baseline, Week 12, and Week 24

    Change from baseline in left ventricular end-diastolic volume (LVEDV, measured in mL) at 12 and 24 weeks

  3. Left ventricular end-diastolic volume index

    Time frame: Baseline, Week 12, and Week 24

    Change from baseline in left ventricular end-diastolic volume index (LVEDVI, measured in mL/m²) at 12 and 24 weeks

  4. Left ventricular end-systolic volume

    Time frame: Baseline, Week 12, and Week 24

    Change from baseline in left ventricular end-systolic volume (LVESV, measured in mL) at 12 and 24 weeks

  5. Left ventricular end-systolic volume index

    Time frame: Baseline, Week 12, and Week 24

    Change from baseline in left ventricular end-systolic volume index (LVESVI, measured in mL/m²) at 12 and 24 weeks

  6. Early diastolic mitral inflow velocity (E)/early diastolic mitral annular velocity (e') ratio

    Time frame: Baseline, Week 12, and Week 24

    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

  7. Global longitudinal strain

    Time frame: Baseline, Week 12, and Week 24

    Change from baseline in global longitudinal strain (GLS, measured in %) at 12 and 24 weeks

  8. Left atrial volume index

    Time frame: Baseline, Week 12, and Week 24

    Change from baseline in left atrial volume index (LAVI, measured in mL/m²) at 12 and 24 weeks

  9. Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical summary score

    Time frame: Baseline, Week 12 and Week 24

    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.

  10. Kansas City Cardiomyopathy Questionnaire (KCCQ) Total summary score

    Time frame: Baseline, Week 12, and Week 24

    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.

  11. Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall summary score

    Time frame: Baseline, Week 12, and Week 24

    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.

Other outcomes

  1. Number and percentage of participants with Treatment-emergent adverse event (TEAEs)

    Time frame: First dose of investigational drug to Week 28 (end-of-study)

    Number and percentage of participants with Treatment-emergent adverse event (TEAEs).

Study contacts

Contact information is provided by the study sponsor or research team.

Cardurion Pharmaceuticals

CONTACT

[email protected]

617-863-8088

Sponsors and collaborators

Lead sponsor

Cardurion Pharmaceuticals, Inc.

Industry

Registry information

Official study 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)

Acronym: CALIBRATE-HF

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 6, 2026
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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