Heart Failure
Conditions
Interventions
To administer i.v. CDR132L (1.36 mg/kg, 4.52 mg/k or 4.52 mg/kg) or placebo Q4W added to standard of care
Sponsors
Suzuki Daisuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Age 40-84 years (both inclusive) at the time of signing the informed consent. -Documented symptomatic HF diagnosed >=90 days prior to screening with at least weekly need for oral diuretic treatment, and New York Heart Association class II-III at screening. -Clinically stable and on optimised doses and unchanged drug classes of guideline-directed HF therapy >=30 days prior to randomisation. -Left ventricular ejection fraction >=50% as assessed by echocardiography at screening, measured by central laboratory. -LVMi >88 g/m2 for female participants and >102 g/m2 for male participants as assessed by echocardiography at screening, using the truncated ellipsoid method measured by central laboratory. -LAVi >=29 mL/m2 as assessed by echocardiography at screening, measured by central laboratory. -Body mass index 18.5-40 kg/m2 (both inclusive) and body weight =300 pg/mL; NT-proBNP >=600 pg/mL if atrial fibrillation/flutter is present at time of screening, measured by central laboratory.
Exclusion criteria
Exclusion criteria: -Estimated glomerular filtration rate 2.5 x upper limit of normal at screening, measured by central laboratory. -Known genetic cause of increased cardiac mass (including likely pathogenic variants within dilated cardiomyopathy, hypertrophic cardiomyopathy and Fabry disease). -Participants with suspected or diagnosed cardiac amyloidosis or sarcoidosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in miR-132 (Week 24) | — |
Countries
Canada, Germany, India, Japan, Korea, Poland, Spain, United Kingdom, United States
Contacts
Public ContactAdministorator Clinical trail information
Novo Nordisk Pharma Ltd.
Outcome results
None listed