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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
Antoine Kimmoun Gad Cotter Beth A. Davison Koji Takagi Faouzi Addad Jelena Celutkiene Ovidiu Chioncel Alain Cohen Solal Rafael Diaz Albertino Damasceno
Antoine Kimmoun
Gad Cotter
Beth A. Davison
Koji Takagi
Faouzi Addad
Jelena Celutkiene
Ovidiu Chioncel
Alain Cohen Solal
Rafael Diaz
Albertino Damasceno
Author
Antoine Kimmoun
Gad Cotter
Beth A. Davison
Koji Takagi
Faouzi Addad
Jelena Celutkiene
Ovidiu Chioncel
Alain Cohen Solal
Rafael Diaz
Albertino Damasceno
Hans-Dirk Duengen
Gerasimos S. Filippatos
Eva Goncalvesova
Imad Merai
Marco Metra
Piotr Ponikowski
Dmitry Privalov
Karen Sliwa
Mahmoud U. Sani
Adriaan A Voors
Zaur Shogenov
Alexandre Mebazaa
Gad Cotter
Beth A. Davison
Koji Takagi
Faouzi Addad
Jelena Celutkiene
Ovidiu Chioncel
Alain Cohen Solal
Rafael Diaz
Albertino Damasceno
Hans-Dirk Duengen
Gerasimos S. Filippatos
Eva Goncalvesova
Imad Merai
Marco Metra
Piotr Ponikowski
Dmitry Privalov
Karen Sliwa
Mahmoud U. Sani
Adriaan A Voors
Zaur Shogenov
Alexandre Mebazaa
Abstract
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.
Keywords
Date
2019
Type
Journal article
Journal
European Journal of Heart Failure
Book
Volume
21
Issue
11
Page Range
1459-1467
Article Number
ACU Department
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Relation URI
Source URL
Event URL
Open Access Status
License
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Controlled