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Heart Failure With Reduced Ejection Fraction (HFrEF)Phase 2CALIBRATE-HFNCT07750873

A Trial of CRD-4730 in HFrEF

A Phase 2 study testing CRD-4730 in people with Heart Failure With Reduced Ejection Fraction (HFrEF), run by Cardurion Pharmaceuticals, Inc. at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
CRD-4730
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
525 participants
Where
2 sitesUnited States
Study dates
15 Jul 2026to Sep 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Cardurion Pharmaceuticals contact

617-863-8088

ClinicalTrialsGov@cardurion.com

United States2 sites, 2 recruiting

  • Cardurion Investigative Site

    Bloomfield Hills, Michigan, 48304

    Abdul-Rahman Halabi, 248-282-3639, abdul.halabi@profoundresearch.io

    Recruiting

  • Cardurion Investigative Site

    Pasadena, California, 91105

    Gregory Giesler, 626-793-1227, gregory.giesler@profoundresearch.io

    Recruiting

Other trials in United States

About this study

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)

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.

Being tested
CRD-4730, Placebo
Keywords
Heart failure
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CRD-4730Drug

    Experimental, Dose A, B and C

  • PlaceboDrug

    Placebo

Study groups in NCT07750873
Study groupRoleWhat they receive
Study Arm 1: CRD-4730 Dose A tabletExperimentalParticipants will receive Dose A of CRD-4730 administered orally twice daily for 24 weeks
Receives: Drug: CRD-4730
Study Arm 2: CRD-4730 Dose B tabletExperimentalParticipants will receive Dose B of CRD-4730 administered orally twice daily for 24 weeks
Receives: Drug: CRD-4730
Study Arm 3: CRD-4730 Dose C tabletExperimentalParticipants will receive Dose C of CRD-4730 administered orally twice daily for 24 weeks
Receives: Drug: CRD-4730
Study Arm 4: Matched Placebo tabletPlacebo comparatorParticipants will receive placebo administered orally twice daily for 24 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and Week 24

Secondary outcomes (11)

  1. NT-proBNP biomarker

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

    Measured: Baseline, Week 12, and Week 24

  2. Left ventricular end-diastolic volume

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

    Measured: Baseline, Week 12, and Week 24

  3. 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

    Measured: Baseline, Week 12, and Week 24

  4. Left ventricular end-systolic volume

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

    Measured: Baseline, Week 12, and Week 24

  5. 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

    Measured: Baseline, Week 12, and Week 24

  6. 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

    Measured: Baseline, Week 12, and Week 24

  7. Global longitudinal strain

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

    Measured: Baseline, Week 12, and Week 24

  8. Left atrial volume index

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

    Measured: Baseline, Week 12, and Week 24

  9. 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.

    Measured: Baseline, Week 12 and Week 24

  10. 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.

    Measured: Baseline, Week 12, and Week 24

  11. 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.

    Measured: Baseline, Week 12, and Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2026
  2. Study start15 Jul 2026
  3. Primary completionSep 2028 (estimated)
  4. Study completionSep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
525 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07750873
Sponsor's protocol ID
CRD-4730-210
Acronym
CALIBRATE-HF
Status last verified
Aug 2026
First submitted
17 Jul 2026
Last updated
6 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CRD-4730 in people with Heart Failure With Reduced Ejection Fraction (HFrEF), run by Cardurion Pharmaceuticals, Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cardurion Pharmaceuticals (617-863-8088, ClinicalTrialsGov@cardurion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Composite Z-Score at 24 weeks (time frame: Baseline and Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07750873, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.

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