Not yet taking people in LithuaniaPhase 2
Tests CRD-4730 in adults with heart failure with reduced ejection fraction
Tests whether CRD-4730 affects heart outcomes in adults with reduced-pumping heart failure.
Key facts
- Who runs it
- Cardurion Pharmaceuticals Inc.
- Where
- Kaunas, Klaipeda, Panevezys, and Vilnius, LithuaniaSee the 5 sitesAlso in 9 other countries, 62 sites
- Trial code
- EU 2025-525033-31-00
- U1111-1335-1337
- Registry 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) (CALIBRATE-HF)
- Status
- Not yet recruiting
- Phase
- Phase 2
- People taking part
- 369 people, planned
- Started
- 11 Sept 2026
- Expected to end
- 28 Sept 2028
- Type of study
- Interventional
- Record updated
- 19 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 85 with long-standing heart failure and a weak heart pumping function (HFrEF), who are already on stable heart failure treatment.
- Age
- 18 to 85 years
- Sex
- Men and women
- Disease stage
- Heart failure for at least 8 weeks, NYHA class II to III, left ventricular ejection fraction (EF) of 40% or lower on a heart ultrasound read centrally.
- Earlier treatment
- Must be on optimized and stable guideline-directed heart failure treatment.
- Biomarker or test result
- NT-proBNP of 600 pg/mL or higher at screening, or 900 pg/mL or higher if in atrial fibrillation or flutter.
Main reasons for not taking part
- Hospital stay or IV/SQ diuretics for a heart failure flare-up within 4 weeks of screening
- Regular scheduled IV infusions or ultrafiltration for heart failure
- Acute coronary syndrome, stroke, or major heart or carotid surgery or procedures within 8 weeks of screening
- Suspected infiltrative or hypertrophic cardiomyopathy
- Heart failure caused by severe valve disease, active myocarditis or pericarditis, or significant congenital heart disease
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- Adult male or female patient ≥ 18 years of age (or adult age as per country guidelines) and ≤ 85 years of age at the time of screening
- Has a medical history supporting a diagnosis of clinical chronic 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 (EF) ≤ 40% by a centrally read transthoracic echocardiogram (TTE) performed during screening
- Has N-terminal pro-B-type natriuretic peptide (NT-proBN) 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)
- Other protocol-defined criteria apply
Who cannot take part
- 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
- Has evidence of recent HF exacerbation defined by hospitalization or requirement for intravenous (IV) or subcutaneous (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
- Other protocol-defined criteria apply
Where in Lithuania
Also in 9 other countries, 62 sites
- Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikosKaunas, LithuaniaNot yet recruiting
- Saules seimos medicinos centras UABKaunas, LithuaniaNot yet recruiting
- Klaipedos universiteto ligonine VšĮKlaipeda, LithuaniaNot yet recruiting
- Respublikine Panevezio ligonine VšĮPanevezys, LithuaniaNot yet recruiting
- Vilniaus universiteto ligonine Santaros klinikos VšĮVilnius, LithuaniaNot yet recruiting
About the trial
What the trial wants to find out
To assess the effect of CRD-4730 on a composite score of cardiovascular endpoints in patients with HFrEF.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- 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) (CALIBRATE-HF)
- Plain-language title
- Tests CRD-4730 in adults with heart failure with reduced ejection fractionGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 19 August 2026