MSB (ASX) Ann: Mesoblast Phase 3 Chronic Heart Failure Results

Originally posted by Davisite: ↑

It is one of the secondary endpoints. The problem is they have so many of them that the statistics get muddy if they don't correct for multiple hypothesis testing - if you have 30 secondary endpoints and you don't correct for multiple hypothesis testing you can expect 1 or 2 to be significant just by chance. Like nearly all of MSB releases this one is very light on details.

Primary Outcome Measures :
Time to recurrent non-fatal decompensated heart failure major adverse cardiac events (HF-MACE) that occur prior to the first terminal cardiac event (TCE). [ Time Frame: 6 Month minimum ]

Secondary Outcome Measures :
Time-to-first terminal cardiac event (TCE) [ Time Frame: 6 Month minimum ]
Time-to-hospital admissions for non-fatal decompensated HF events [ Time Frame: 6 Month minimum ]
Time-to-urgent care outpatient HF visits [ Time Frame: 6 Month minimum ]
Time-to-successfully resuscitated cardiac death (RCD) events [ Time Frame: 6 Month minimum ]
Total length of in-hospital stay in intensive care unit for non-fatal decompensated HF events [ Time Frame: 6 Month minimum ]
Time-to-first HF-MACE (composite of hospital admissions for decompensated HF, urgent care outpatient HF visit, and successfully RCD events) [ Time Frame: 6 Month minimum ]
Time-to-first HF-MACE (composite of hospital admissions for decompensated HF, urgent care outpatient HF visit, successfully RCD events or TCE) [ Time Frame: 6 Month minimum ]
Time-to-cardiac death [ Time Frame: 6 Month minimum ]
Time-to-all-cause death [ Time Frame: 6 Month minimum ]
Time-to-first non-fatal MI (myocardial infarction), non-fatal CVA (cerebrovascular attack) or coronary artery revascularization [ Time Frame: 6 Month minimum ]
Left Ventricular (LV) remodeling in LVESV determined by 2-D echocardiography [ Time Frame: Screening, day 0 (post-procedure), months 3, 6, and 12, and every 12 months thereafter during study conduct (6 Month minimum) ]
Correlations between baseline LVESV <=100 mL and LVESV >100 mL and clinical outcomes [ Time Frame: 6 Month minimum ]
Correlations between baseline LVESV <=100 mL and LVESV >100 mL and change in Month 6 to baseline LVESV and clinical outcomes [ Time Frame: 6 Month minimum ]
LV remodeling in LVEDV determined by 2-D echocardiography [ Time Frame: Screening, day 0 (post-procedure), months 3, 6, and 12, and every 12 months thereafter during study conduct (6 Month minimum) ]
Overall Left Ventricular systolic performance as assessed by LVEF (RVG or echocardiogram) [ Time Frame: Screening, day 0 (post-procedure), months 3, 6, and 12, and every 12 months thereafter during study conduct (6 Month minimum) ]
Functional exercise capacity as assessed by 6 Minute Walk Test [ Time Frame: Screening, months 3, 6, and 12, and every 12 months thereafter during study conduct (6 Month minimum) ]
Functional status by New York Heart Association (NYHA) class [ Time Frame: Screening, months 3, 6, and 12, and every 12 months thereafter during study conduct (6 Month minimum) ]
Quality of Life Measure - Minnesota Living With Heart Failure (MLHF) questionnaire [ Time Frame: Screening, months 3, 6, and 12, and every 6 months thereafter during study conduct (6 Month minimum) ]
Quality of Life Measure - EuroQoL 5-dimensional (EQ-5D) questionnaire [ Time Frame: Screening, months 3, 6, and 12, and every 6 months thereafter during study conduct (6 Month minimum) ]
Safety as assessed by occurrence of adverse events related to the index cardiac catheterization on Day 0 [ Time Frame: Day 0 through discharge from Day 0 hospitalization ]
Safety as assessed by occurrence of treatment-emergent adverse events [ Time Frame: Screening through 6 Month minimum ]
Safety as assessed by clinical laboratory tests (serum chemistry - ALT, AST, alkaline phosphate, GGT, LDH, BUN, creatinine, uric acid, total bilirubin - and hematology - hematocrit, hemoglobin, WBC, eosinophils, ANC, platelet count) [ Time Frame: Screening, day 0 (post-procedure), day 10, months 1, 3, 6, and 12, and every 6 months thereafter during study conduct (6 Month minimum) ]
Safety as assessed by urinalysis (blood, glucose, ketones, total protein) [ Time Frame: Screening, day 10, months 1, 3, 6, and 12, and every 6 months thereafter during study conduct (6 Month minimum) ]
Safety as assessed by vital signs (pulse, systolic BP, diastolic BP) [ Time Frame: Screening, day 0 (pre and post-procedure), day 1, day 10, months 1, 3, 6, and 12, and every 6 months thereafter during study conduct (6 Month minimum) ]
Safety as assessed by 12-lead electrocardiogram (ECG) findings - QTcF, QTcB, QT, QRS complex, HR and T waves. [ Time Frame: Screening, day 0 (pre and post-procedure), day 1, day 10, months 1, 3, 6, and 12, and every 6 months thereafter during study conduct (6 Month minimum) ]
Safety as assessed by telemetry monitoring findings (clinically significant arrhythmias) [ Time Frame: Day 0 through Day 0 overnight post-procedure ]
Safety as assessed by rhythm analysis (specifically, ventricular arrhythmias) by interrogation of any implanted device capable of defibrillation [ Time Frame: Day 10, months 1, 3, 6, and 12, and every 6 months thereafter during study conduct (6 Month minimum) ]
Safety as assessed by 24-hr Holter monitoring (HR, rate & duration of arrhythmias, a-fib average rate, supra- & ventricular ectopy singles/couplets/runs/totals, sustained & non-sustained ventricular tachycardia, longest pauses RR duration, total pauses) [ Time Frame: Screening, day 0 (post-procedure), day 10, months 1 and 3 ]
Safety as assessed by physical examination findings judged as clinically significant changes from baseline by the investigator or newly occurring abnormalities (including weight) [ Time Frame: Screening, month 12 and every 12 months thereafter until study conclusion (weight measured at screening, day 0 - pre and post-procedure, day 1, day 10, months 1, 3, 6 and 12 and every 6 months thereafter) ]
Safety as assessed by important cardiovascular events from adjudicated data [ Time Frame: 6 Month minimum ]

Expand

“The problem is they have so many of them that the statistics get muddy if they don't correct for multiple hypothesis testing”

hard to mistake dead, for not dead! the cleanest data you can get! 60% at p=0.002

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Ann: Mesoblast Phase 3 Chronic Heart Failure Results, page-622

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Ann: Mesoblast Phase 3 Chronic Heart Failure Results, page-622

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