WorksheetsMR CERTIFICATION QUIZ
Total questions: 50
Worksheet time: 50mins
1. Patients with implantation of CRT/D within 6months and those with cardiac implantation were also included in PROVE HF the trial.
a. True
b. False
1. What is the primary result of the EVALUATE HF trial?
. Entresto did not reduce aortic impedance at week 12 compared to Enalapril
From baseline to 12 months, significant correlations were observed between the change in NT-proBNP concentration and cardiac remodeling parameters.
Which of the following is not part of the inclusion criteria of Evaluate?
Age >/= 50 yrs
SBP >105 mmHg at randomization
Stable dose of GDMT
Aged ≥18 years
Below are the Key inclusion criteria in the PROVE HF except:
Current or previous treatment with sacubitril/valsartan
LVEF ≤40% within the preceding 6 months according to any local measurement, and no subsequent documentation of EF >40%
Aged ≥18 years Patients with HFrEF who are candidates for on-label sacubitril/valsartan treatment per the standard of care
Patients with implantation of CRT/D within 6months and those with cardiac implantation were also included in the PROVE HF trial.
TRUE
FALSE
PROVE HF is a double blind randomized trial with 48 weeks included 975 hospitalized HFrEF patients.
FALSE
TRUE
Sacubitril-valsartan (Entresto®) is indicated to reduce the risk of cardiovascular mortality and morbidity in adult patients with systolic heart failure (NYHA class II-IV, LVEF ≤ 40%).
TRUE
FALSE
In the EVALUATE trial Entresto significantly reduce aortic impedance at week 12 compared to Enalapril.
TRUE
FALSE
From EVALUATE Trial, As young as >=18y/o were included in the screening period.
TRUE
FALSE
Significant improvement in QOL vs Enalapril as evident by improvement in KCCQ score from the Evaluate Trial
FALSE
TRUE
Majority of the patients in the Evaluate HF have history of hypertension and a reduced EF of <40%.
TRUE
FALSE
In the Evaluate HF Trial, patients were included belonged to NYHA Classification II-IV.
FALSE
TRUE
Sacubitril-valsartan (Entresto®) is administered in combination with other heart failure therapies (e.g. beta blockers, diuretics, and mineralocorticoid antagonists) as appropriate, in place of an ACE inhibitor
TRUE
FALSE
What is the most common adverse event seen among patients taking Entresto?
hypokalemia
dizziness
hypotension
What is the recommended starting dose of sacubitril-valsartan (Entresto®)?
100mg BID
50 mg BID
What is the starting dose of Entresto and recommended for patients not currently taking an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), and should be considered for patients previously taking low doses of these agents.
50 mg BID
100 mg BID
What is the recommended dose for geriatric patients?
Sacubitril-valsartan (Entresto®) has not been studied. Use of sacubitrilvalsartan (Entresto®) is not recommended
Dose should be in line with renal function of elderly patient.
50mg BID
What is the recommended dose of Entresto in patients with moderate hepatic impairment?
50mg BID
Not Recommended
What is the recommended dose for patients with Child-Pugh C Classification?
start low dose at 50mg BID
Not recommended
Entresto can be given to patients with mild hepatic impairment with no dose adjustment.
True
False
In patients with end-stage renal disease use of sacubitrilvalsartan (Entresto®) is not recommended.
False
True
A starting dose of Entresto 50 mg twice daily and caution is recommended in patients with severe renal impairment
True
False
BNP is not a suitable biomarker of heart failure in patients treated with sacubitril-valsartan (Entresto®) because it is a neprilysin substrate.
true
false
Which drug belonging to OATP1B1 and OATP1B3 substrate should be used with caution when used concomittanly with Entresto because of its potential drug interaction?
MRA
Aliskerin
Statin
What is the primary endpoint of the TRANSITION Study?
To evaluate the proportion of patients achieving the target dose of ENTRESTO 200 mg BID at Week 10 post-randomization in the pre- and post discharge treatment initiation groups
Time-averaged proportional change in NT-proBNP concentration from baseline through Weeks 4 and 8
PIONEER-HF trial reconfirms that in-hospital initiation of Entresto shortly after decompensation has a safety comparable to Enalapril.
True
False
In the PIONEER HR, Stabilized while in the hospitalized means what?
No increase in IV diuretics in prior 6h
No IV inotropes in prior 24h
No IV vasodilators in prior 6h
All of the above
What is the study duration of PIONEER-HF?
12 weeks
8 weeks
10 weeks
What is the result of the PIONEER-HF study?
Significantly greater and more rapid reductions in NT-proBNP, an established biomarker for HF severity and prognosis
Incidence of AEs and ENTRESTO discontinuations due to AEs was similar among in-hospital and ambulatory initiation groups
21% reduction in mortality and morbidity
What is the primary objective of the PIONEER-HF study?
Time-averaged proportional change in NT-proBNP concentration from baseline through Weeks 4 and 8
To evaluate the proportion of patients achieving the target dose of ENTRESTO 200 mg BID at Week 10 post-randomization in the pre- and post discharge treatment initiation groups
How many patients were included in the PIONEER-HF study?
1002
788
887
How many patients were included in the EVALUATE HF trial?
456
465
546
What is the study duration of PROVE HF?
12 months
12 weeks
8 weeks
There was a rapid and significant reduction of NT-proBNP observed, with majority of reduction within the first 2 week seen from the PROVE HF.
True
False
In the methodology of PROVE HF, an echocardiogram was performed at baseline, 6- and 12-months, and interpreted by a core lab in a clinically and temporally blinded fashion.
True
False
The key primary objective of PROVE HF is to examine the correlation of NT-proBNP levels with changes in structural cardiac measurements and KCCQ-23 from baseline to 6 months.
True
False
PROVE HF is a Phase III Trial designed to assess and examine the association between changes in concentration of NT-proBNP and cardiac remodeling, assessed by echocardiographic parameters of volume (LV end systolic and diastolic volume indices, LVEF, and left atrial volume index) from baseline to 1 year.
True
False
What is the potassium level of patients that were not included in the study?
Potassium >5.2 mEq/L at screening
Potassium <5.2 mEq/L at screening
In the PROVE HF, What percentage of patients in the trial are taking Beta Blocker?
75%
95%
65%
1. How many patents were included in the TRANSITION Study?
887
1002
5442
e novo patients or newly diagnosed HF patients were included in the TRANSITION study.
True
False
What is the result of the TRANSITION study?
Comparable proportions of patients met the primary and secondary end points in the pre- and postdischarge initiation groups
Rapid 28% reduction from baseline at discharge in predischarge group
Superiority of ENTRESTO over ACEi as shown in PARADIGM-HF, now demonstrated in the hospital setting in a wide range of patients with HFrEF who have been haemodynamically stabilised after an acute decompensated HF event, including ACEi/ARB-naïve and newly diagnosed (de novo) patients
In the TRANSITION study, Entresto was given to heart failure patient after acute decompensation once patient is already stabilized
True
False
In the TRANSITION study, about half of patients with HFrEF stabilised after an ADHF event did not achieve the target dose of 200mg ENTRESTO BID within 10 weeks.
True
False
At Week 10 of the TRANSITION study, how many percent of patients in both groups were receiving any dose for 2 weeks or longer without interruption?
86%
76%
89%
What is the percentage of patients in the Transition study were ACE / ARB naive?
34%
24%
39%
What is the percentage of patients in the Transition Study were De Novo or Newly Diagnosed HF Patient?
29%
24%
59%
Sacubitril-Valsartan alone amongst newly proven treatments has been shown to be safe and effective in the acute hospitalization & OPD setting.
True
False
What is the 2021 Update to the 2017 ACC Expert Consensus Decision Pathway for Optimization of Heart Failure Treatment Recommendation for Entresto?
ARNI/ACEI/ARB (ARNI Preferred: AND evidence-based beta-blocker with diuretic agent as needed. A direct-to-ARNI approach is now recommended.
ACEi/ARB should only be considered in patients with contraindications, intolerance or inaccessibility to ARNI. ACEI/ARB are still the first line of treatment for HfrEF
What is the ESC Consensus paper recommendation for Entresto on Hospitalized patients with HFrEF?
ACEi/ARB should only be considered in patients with contraindications, intolerance or inaccessibility to ARNI
Initiation of Sacubitril-Valsartan rather than an ACE-I or an ARB may be considered for patients hospitalized with new-onset HF or decompensated CHF to reduce the short-term risk of adverse events and to simplify management (by avoiding the need to titrate ACE-I first and then switch to Sacubitril-Valsartan)
