WorksheetsHefpf
Total questions: 37
Worksheet time: 21mins
What is the estimated risk reduction of sacval vresus putative placebo comparing Paragon HF and CHARM Preserve Trial?
29
49
13%
In Paragaon HF, Entresto demonstrated a numerical reduction vs valsartan in the primary end point, a composite endpoint of total (first and recurrent) HF hospitalization and cv death, and missed statistical significance with p value of .56
False
True
Maybe
What are the 2 pre specified sub groups that reached statistical significance in the ParagonHF TRIAL?
Female Subgroup
Male subgroup
> 57% EF
Less than or equal to 57%
What is the study design of Paragon HF study?
Randomized, open label
Randomized, double blind, parallel group, active control, event driven trial
Prospective observational parallel group study
Randomized double blind parallel group study
Mortality benefits were observed in major Hfpef trial like CHARM PRESERVED.
True
False
What treatments were used in the Paragon HF Study?
Sacval 100mg BID and valsartan 80mg BID
Sacval 200mg OD and valsartan 160 mg BID
Sacval 200mg BID and Valsartan 160 mg BID
Sacval 50mg BID and valsartan 160 OD
Normal EF has been defined anywhere in the 53-73% EF range although there is a consensus among physicians that LVEF measurements may have variability
True
False
What is the new lanel indication of Entresto in adult HF patients?
Entresto is indicated to reduce the risk of CV DEATH and HF hospitalization for HF patients specifically for LVEF <40%
Entresto is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic hf. Benefits are most clearly evident in patients with left ventricular ejection fraction below normal
Entresto is indicated to reduce all cause mortality in HF patients
Entresto is indicated to reduce cv death and hospitalization for hf patients for btoh hfref and hfpef
What is the result of the pooled analysis of PARADIGM HF and PaARAGON HF studies
The effect across the EF groups is supported by similar findings in external HFPEF studies and Paradigm HF, pointing towards a consistency of the treatment of sacval accross the continuum of the EF range with and upper cut-off point at 57% based on PARAGON HF
The effect of sacval promises clinical benefits only for EF groups of < 40% and possible benefits of hfpef
Entresto is the first and Only treatment to be studied in Hfpef patients (defined in the ParagonHF trial as having lvef >45% no prior documented history of LVEF <40% and confirmed structural heart disease) vs an active comparator, valsartan.
True
False
How much reduction was seen in the primary endpoint in the Paragon HF study
26%
20%
21%
13%
What are the 3 pre specified outcomes where results in the
ARADIGM HF favored SACVAL vs valsartan?
Nyha change from baseline
Change in KCCQ
Cv death and hfhospitalization
Renal composite endpoint
Which study provided rationale to pursue PARAGON HF for HFPEF
Paradigm HF
Panorama
Prove
PARAMOUNT
What is the primary outcome of the paramount study?
Change in nt pro bnp
Cv death and hospitalization
All cause mortality
Cv death
In the Paragon Hf study, relative risk reduction of the primary outcome by sac val was driven by cv death
True
False
What is the primary outcome of the Paragon HF Study?
Cv death
Change in nt pro bnp
Cv death and total (fisrt and recurrent) HF hospitalizations
All of the above
What is the p- value of the outcome in the PARAGON HF study?
.055
.5
.01
.059
Secondary efficacy endpoints of KCCQ score, NYHA class and renal endpoints consistently favor sacubitril valsartan
True
False
What is the result ofthe Paramount HF study?
20% reduction in NT PRO BNP
23% reduction in NT PRO BNP
21% reduction in hf hospitalization
20% reduction in all cause mortality
What is the median EF where benefits were seen in the PARAGON HF sub analysis?
55%
37%
57%
47%
What is the cut off lvef criteria recruited for PARAGON HF study?
>45%
<45%
<35%
<40%
Which of the following is NOT true about why valsartan was used as comparator drug in PARAGON HF study
Valsartan is a commonly prescribed ARB and the target dose of the sacval delivers systemic exposure similar to the target dose of valsartan
Valsartan is the gold standard treatment for hfpef
A placebo comparator was not considered appropriate in this long term trial, as the comorbidities commonly present in HFPEF patients require raas inhibition
The need to treat comorbiditites with an indication of RAAS BLOCKADE
Previous HFPEF clinical trisl were all compared to a placebo
True
False
A potential benefit of sacval versus valsartan in patients with an ef below the median 57% and in women vs men were observed.
True
False
The overall safety profile was similar to that of the PARADIGM HF
True
False
Active comparator in Paragon and Paramount
Valsartan
Emapaglifozin
Enalapril
Placebo
Which of the following statements is not true
Hf being progressive disease, even modest changes in LVEF can lead to clinically significant changes in outcomes
Patients with abnormal lvef ahve heightened risk of hf hospitalization and cv death
Repeated hospitalization in Hf with EF below 40% result in a considerable and progressive burden for those impacted, poor qOL and limited survival
Hospitalization and read,ission rates are high for HF across the Lvef spectrum
Which of the following does not decribe eccentric remodelling
Stimulus causing volume overload in the ventricle
Cause by increase in pressure(hypertension )
Heart muscle in cell length > width
Reduced wall thickness and dilation of the chamber cavity
Hfpef is characterized by imapired filling and relaxation of the left ventricle
True
False;
Which of the following is a sign or symptom of a right sided failure
Hemoptysis
Dysnea
Bipedal edema
Which of the following best describes the 4 pillars of HF management
Acei/arni + bb + mra + sglt2i
Bb + mra + vasodilators + sglt2i
Mra + nitrates + sgl2i + acei
Across the spectrum of HF, patients with abnormal LVEF have elevated risks
True
False
Which type of hf is characterized as life threatening rapid onset and the underlying mechanisms is transient and reversible
Chronic hf
Acute hf
Hefref
Hefpef
Multivariate analyses show heterogeneity in the treatment response to sacubitril/valsartan across EF and gender subgroups
True
False
Post hoc analyses from trials with candesartan2 and spironolactone3 by EF suggest that reduction of risk of HF hospitalization may extend to HFmrEF and even to the lower part of the LVEF range of HFpEF
True
False
Supportive analyses of expanded composite endpoint, investigator reported events & re-adjudication of CEC unconfirmed events provide a consistent pattern of the treatment effect of sacubitril/valsartan which provides confidence that a true treatment effect exists in the overall study
True
False
In PARAGON-HF as the active comparator trial and CHARM-Preserved† as the reference trial, the estimated risk reduction of sacubitril/valsartan versus putative placebo was _____
21%
29%
39%
13%
