Τίτλος:
Safety, Tolerability and efficacy of Rapid Optimization, helped by NT-proBNP and GDF-15, of Heart Failure therapies (STRONG-HF): rationale and design for a multicentre, randomized, parallel-group study
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
Aims: Patients admitted for acute heart failure (HF) are at high risk of readmission and death, especially in the 90 days following discharge. We aimed to assess the safety and efficacy of early optimization of oral HF therapy with beta-blockers (BB), angiotensin-converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB) or angiotensin receptor–neprilysin inhibitors (ARNi), and mineralocorticoid receptor antagonists (MRA) on 90-day clinical outcomes in patients admitted for acute HF. Methods: In a multicentre, randomized, open-label, parallel-group study, a total of 900 patients will be randomized in a 1:1 ratio to either ‘usual care’ or ‘high-intensity care’. Patients enrolled in the usual care arm will be discharged and managed according to usual clinical practice at the site. In the high-intensity care arm, doses of oral HF medications – including a BB, ACEi or ARB, and MRA – will be up-titrated to 50% of recommended doses before discharge and to 100% of recommended doses within 2 weeks of discharge. Up-titration will be delayed if the patients develop worsening. symptoms and signs of congestion, hyperkalaemia, hypotension, bradycardia, worsening of renal function or significant increase in N-terminal pro-B-type natriuretic peptide between visits. The primary endpoint is 90-day all-cause mortality or HF readmission. Conclusions: STRONG-HF is the first study to assess whether rapid up-titration of evidence-based guideline-recommended therapies with close follow-up in a large cohort of patients discharged from an acute HF admission is safe and can affect adverse outcomes during the first 90 days after discharge. Clinical Trial Registration: ClinicalTrials.gov Identifier NCT03412201. © 2019 The Authors. European Journal of Heart Failure © 2019 European Society of Cardiology
Συγγραφείς:
Kimmoun, A.
Cotter, G.
Davison, B.
Takagi, K.
Addad, F.
Celutkiene, J.
Chioncel, O.
Solal, A.C.
Diaz, R.
Damasceno, A.
Duengen, H.-D.
Filippatos, G.
Goncalvesova, E.
Merai, I.
Metra, M.
Ponikowski, P.
Privalov, D.
Sliwa, K.
Sani, M.U.
Voors, A.A.
Shogenov, Z.
Mebazaa, A.
Περιοδικό:
European Journal of Heart Failure
Εκδότης:
John Wiley and Sons Ltd
Λέξεις-κλειδιά:
amino terminal pro brain natriuretic peptide; angiotensin receptor antagonist; beta adrenergic receptor blocking agent; biological marker; bisoprolol; candesartan; captopril; carvedilol; dipeptidyl carboxypeptidase inhibitor; enalapril; enkephalinase inhibitor; eplerenone; lisinopril; losartan; metoprolol succinate; mineralocorticoid antagonist; nebivolol; perindopril; ramipril; sacubitril plus valsartan; spironolactone; trandolapril; valsartan; angiotensin receptor antagonist; beta adrenergic receptor blocking agent; biological marker; brain natriuretic peptide; dipeptidyl carboxypeptidase inhibitor; GDF15 protein, human; growth differentiation factor 15; membrane metalloendopeptidase; mineralocorticoid antagonist; peptide fragment; pro-brain natriuretic peptide (1-76), all cause mortality; Article; cardiovascular mortality; controlled study; drug efficacy; drug safety; drug tolerability; evidence based practice; follow up; heart failure; hospital admission; hospital discharge; hospital readmission; human; major clinical study; multicenter study; open study; parallel design; priority journal; randomized controlled trial; acute disease; aged; blood; cause of death; clinical trial; comparative study; female; heart failure; male; middle aged; mortality; patient safety; protocol compliance; survival rate; treatment outcome, Acute Disease; Adrenergic beta-Antagonists; Aged; Angiotensin Receptor Antagonists; Angiotensin-Converting Enzyme Inhibitors; Biomarkers; Cause of Death; Female; Growth Differentiation Factor 15; Guideline Adherence; Heart Failure; Humans; Male; Middle Aged; Mineralocorticoid Receptor Antagonists; Natriuretic Peptide, Brain; Neprilysin; Patient Admission; Patient Readmission; Patient Safety; Peptide Fragments; Survival Rate; Treatment Outcome
