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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515796-35-00

Acronym

NN6706-8212

Enrollment

Registered

2025-05-28

Start date

2025-06-26

Completion date

Unknown

Last updated

2025-11-30

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

Conditions

Heart Failure with Preserved 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 LVMi (CMR), LAVi (CMR) and NT-proBNP from baseline (V2) to week 24 (V14). Unit: Score, Change in normalised miR-132 from baseline (V2) to week 24 (V14). Unit: Ratio to baseline, 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 LVMi (CMR), LAVi (CMR) and NT-proBNP from baseline (V2) to week 24 (V14). Unit: Score, Change in normalised miR-132 from baseline (V2) to week 24 (V14). Unit: Ratio to baseline, 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

Germany, Poland, Spain

Outcome results