Phase 2, Multicentre, Randomised, Double-blind, Placebo-controlled Safety and Efficacy Study of CDR132L on Reverse Cardiac Remodelling in Participants with Heart Failure with Reduced/Mildly Reduced Ejection Fraction and Left Ventricular Hypertrophy.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515797-27-00

Acronym

NN6706-8282

Enrollment

101

Registered

2025-05-26

Start date

2025-06-25

Completion date

Unknown

Last updated

2025-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure with Reduced/Mildly Reducede Ejection Fraction and Left Ventricular Hypertrophy.

Brief summary

Change in normalised miR-132 from baseline (V2) to week 24 (V14). Unit: Ratio to baseline

Detailed description

Change in composite Z score based on the 3 outcome measures LVEDVi, LVESVi and NT-proBNP from baseline (V2) to week 24 (V14). Unit: Score, Number of adverse events from baseline (V2) to week 24 (V14). Unit: Count, Number of adverse events from baseline (V2) to week 60 (V27). Unit: Count

Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change in normalised miR-132 from baseline (V2) to week 24 (V14). Unit: Ratio to baseline	—

Secondary

Measure	Time frame
Change in composite Z score based on the 3 outcome measures LVEDVi, LVESVi and NT-proBNP from baseline (V2) to week 24 (V14). Unit: Score, Number of adverse events from baseline (V2) to week 24 (V14). Unit: Count, Number of adverse events from baseline (V2) to week 60 (V27). Unit: Count	—

Countries

Czechia, Germany, Netherlands, Poland, Spain

Outcome results