Phase 2
Completed N=36
Pilot Study of COR-1 in Heart Failure
Cardiomyopathy, Dilated
Source: ClinicalTrials.gov NCT01391507 ↗
Enrolled (actual)
36
Serious AEs
25.0%
Results posted
Aug 2014
Primary outcomePrimary: Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 6 — 35.4; 29.4; 35.0; 32.4 Percentage of blood pumped out
Summary
The purpose of this study is to investigate the effect of COR-1 in combination with standard therapy in patients with heart failure. The safety and tolerability of COR-1 will also be assessed.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 6 |
35.4; 29.4; 35.0; 32.4; -1.6; 0.8 | — |
| SECONDARY Change From Baseline in Local Left Ventricular Ejection Fraction (LVEF) at Month 9 |
32.6; 33.6; 35.3; 32.5; -0.8; -1.9 | — |
| SECONDARY Change From Baseline in N-Terminal Pro B-Type Natriuretic Peptide (NT-ProBNP) Level at Month 6 |
5678.0; 2215.9; 971.4; 2299.4; -805.7; 1363.4 | — |
| SECONDARY Change From Baseline in Central Transmitral Flow Velocity Time Integral (VTI) at Month 6 |
45.0; 21.0; 0.0; 0.0 | — |
| SECONDARY Change From Baseline in Central Tissue E-Wave Doppler Mitral Annular Velocity at Month 6 |
5.6; 5.2; 4.0; 5.8; -0.2; 0.0 | — |
| SECONDARY Change From Baseline in Distance Walked During Six-minute Walk Test at Month 6 |
421.1; 451.1; 395.2; 420.7; 38.7; -8.7 | — |
| SECONDARY Number of Participants With New York Heart Association (NYHA) Classification of Disease Progression |
7; 8; 3; 7; 3; 0 | — |
| SECONDARY Change From Baseline in Minnesota Living With Heart Failure Questionnaire Score at Month 6 |
23.7; 21.4; 33.2; 25.9; 3.3; 3.3 | — |
| SECONDARY Change From Baseline in Holter Electrocardiography (ECG) Parameters (Heart Rate) at Month 6 |
74.6; 76.9; 84.2; 75.3; 1.3; -0.9 | — |
| SECONDARY Number of Participants With Holter Electrocardiography (ECG) Parameters |
7; 7; 5; 7; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosed heart failure due to dilated cardiomyopathy with left ventricular ejection fraction 1 year and = 50% coronary artery stenosis and/or history of myocardial infarction
- Third or higher degree valvular defect
- Any disease requiring immunosuppressive drugs (except for <= 5 mg/day prednisone-equivalent dose) or any clinically relevant disorder of the immune system
- History of severe allergies and increased risk for anaphylactic shock (e.g., bronchial asthma)
- History of, or currently active illness, considered to be clinically significant by the Investigator or any other illness that the Investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results
Data sourced from ClinicalTrials.gov (NCT01391507). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.