This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study including approximately 130 randomized HF patients with heart failure with mildly reduced or preserved ejection fraction (LVEF ≥45%), to assess efficacy and safety of CDR132L on reverse remodeling. In this study, patients with HFpEF (EF ≥50%) or HFmrEF (LVEF 45-49%) will be included.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
CDR132L is a synthetic antisense oligonucleotide (ASO) and a selective inhibitor of microRNA-132-3p (miR-132). miR-132 in cardiomyocytes is a central switch affecting the expression of genes that are crucially involved in maladaptive cardiac remodeling, transformation, and pathological cardiac growth (hypertrophy), contributing to adverse cardiac remodeling and heart failure (HF).1-5 Aberrant expression of miR-132 in cardiac cells is causally associated with cardiac remodeling and HF progression.
Placebo to CDR132L
Left ventricular mass
Left ventricular mass measured by cardiac magnetic resonance imaging (indexed to the height in meters raised to the power of 2)
Time frame: 6 months
Left atrial maximum volume
Left atrial maximum volume (measured by cardiac magnetic resonance imaging in end systole(indexed to the height in meters raised to the power of 2))
Time frame: 6 months
Total cardiac extracellular volume
Total cardiac extracellular volume (mL) measured by cardiac magnetic resonance imaging
Time frame: 6 months
Left atrial strain
Left atrial strain measured by cardiac magnetic resonance imaging
Time frame: 6 months
Maximum left ventricular wall thickness
Maximum left ventricular wall thickness measured by cardiac magnetic resonance imaging
Time frame: 6 months
Age-adjusted e' velocity
Age-adjusted e' velocity measured by doppler echocardiography. With e´velocity being the maximal velocity of mitral annular motion (E-wave).
Time frame: 6 months
Global longitudinal strain
Global longitudinal strain measured by echocardiography
Time frame: 6 months
E/e'
E/e' measured by doppler echocardiography to evaluate the LV filling pressure.
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Concentration of N-terminal pro B-type natriuretic peptide
Concentration measured as biomarker from blood samples.
Time frame: 6 months
Concentration of high-sensitivity cardiac troponin T
Concentration measured as biomarker from blood samples.
Time frame: 6 months