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A Research Study Comparing Different Doses of CDR132L With Placebo on the Structure and Function of the Heart in People With Heart Failure With Preserved Ejection Fraction and Left Ventricular Hypertrophy

ConditionHeart Failure
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-84
SponsorNovo Nordisk A/S

About this trial

This study will look into how CDR132L (a potential new medicine) works on the structure and function of the heart in people living with heart failure. Participants will either get CDR132L or placebo (a medicine which has no effect on the body), which treatment the participants get is decided by chance. The study will last for about 60 weeks.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 40-84 years (both inclusive) at the time of signing the informed consent

Documented symptomatic chronic heart failure (HF) diagnosed greater than or equal to (≥) 90 days prior to screening with at least weekly need for oral diuretic treatment, and/or a sodium-glucose cotransporter-2 inhibitor (SGLT2i), 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 ≥45 days prior to randomisation

Left ventricular ejection fraction ≥40% as assessed by echocardiography at screening, measured by central laboratory

Disqualifiers

Estimated glomerular filtration rate lesser than (<) 30 milliliter per minute (mL/min)/1.73 square meter (m²) at time of screening, measured by central laboratory

Participants with an episode of acute kidney failure or acute kidney injury, at the discretion of the investigator, within 90 days prior to randomisation

Myocardial infarction, unstable angina pectoris or HF hospitalisation within 30 days prior to screening

Participants receiving intravenous HF medications within 45 days prior to randomisation

Trial design

Design model

Parallel

Treatments tested in this trial

  • CDR132L

    Drug

    CDR132L will be administered intravenously once every 4 weeks.

  • Placebo

    Drug

    Placebo will be administered intravenously once every 4 weeks.

Treatment groups

200 Participants
are divided into 4 treatment groups
Group A: CDR132L: Dose 1Experimental treatment 1 intervention
Group B: CDR132L: Dose 2Experimental treatment 1 intervention
Group C: CDR132L: Dose 3Experimental treatment 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Main phase: Change in normalised microRNA-132-3p (miR-132)

Measured as ratio to baseline.

Time frame
From baseline to week 24

Secondary outcomes

1

Main phase: Composite Z-score based on changes in the 3 outcome measures LVMi (CMR), LAVi (CMR) and NT-proBNP

The composite Z-score is calculated as the mean of the participant's 3 Z-scores for the change in the 3 outcome measures: left ventricular mass indexed to body surface area \[LVMi (Cardiovascular Magnetic Resonance \[CMR\])\], left atrial volume indexed to body surface area \[LAVi (CMR)\] and N-terminal pro B-type natriuretic peptide (NT-proBNP).

Time frame
From baseline to week 24
2

Main phase: Change in normalised miR-132

Measured as ratio to baseline.

Time frame
From baseline to week 24
3

Main phase: Number of adverse events

Measured as count of events.

Time frame
From baseline to week 24
4

Extension phase: Number of adverse events

Measured as count of events.

Time frame
From baseline to week 60

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Novo Nordisk A/S

Lead sponsor

Source ClinicalTrials.gov
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