Antoine Kimmoun1, Gad Cotter2, Beth Davison2, Koji Takagi1, Faouzi Addad3, Jelena Celutkiene4, Ovidiu Chioncel5, Alain Cohen Solal1,6, Rafael Diaz7, Albertino Damasceno8, Hans-Dirk Duengen9, Gerasimos Filippatos10, Eva Goncalvesova11, Imad Merai12, Marco Metra13, Piotr Ponikowski14, Dmitry Privalov15, Karen Sliwa16, Mahmoud Umar Sani17, Adriaan A Voors18, Zaur Shogenov19, Alexandre Mebazaa1,20. 1. INSERM UMR-S 942, St. Louis and Lariboisère University Hospitals, Paris University, Paris, France. 2. Momentum Research Inc., Durham, NC, USA. 3. Department of Cardiology, Abderrahmen Mami University hospital, Ariana, Tunisia. 4. Clinic of Cardiac and Vascular Diseases, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania. 5. Emergency Institute for Cardiovascular Diseases 'Prof. C.C. Iliescu', University of Medicine 'Carol Davila', Bucharest, Romania. 6. Department of Cardiology, Lariboisère University Hospital, Paris, France. 7. Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina. 8. Eduardo Mondlane University Hospital, Maputo, Mozambique. 9. Department of Internal Medicine - Cardiology, Campus Virchow Klinikum, Charité - Universitätsmedizin Berlin, Berlin, Germany. 10. Heart Failure Unit, Attikon University Hospital, National and Kapodistrian University of Athens, Greece; School of Medicine, University of Cyprus, Nicosia, Cyprus. 11. Department of Heart Failure and Transplantation, National Institute of Cardiovascular Diseases, Bratislava, Slovak Republic. 12. Cardiac Care Unit, Moscow City Hospital, Moscow, Russia. 13. Cardiology, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Brescia, Italy. 14. Department of Heart Diseases, Wroclaw Medical University, Wroclaw, Poland. 15. Critical Cardiac Unit, City Clinical Hospital, Moscow, Russia. 16. Division of Cardiology, Department of Medicine, Groote Schuur Hospital and University of Cape Town, Cape Town, South Africa. 17. Department of Medicine, Bayero University Kano, Kano, Nigeria. 18. Department of Cardiology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands. 19. Moscow SHI, City Clinical Hospital, Moscow, Russia. 20. Department of Anesthesiology and Critical Care Medicine, St. Louis and Lariboisère University Hospitals, Paris, France.
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. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT03412201.
RCT Entities:
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.
Authors: Wouter C Meijers; Antoni Bayes-Genis; Alexandre Mebazaa; Johann Bauersachs; John G F Cleland; Andrew J S Coats; James L Januzzi; Alan S Maisel; Kenneth McDonald; Thomas Mueller; A Mark Richards; Petar Seferovic; Christian Mueller; Rudolf A de Boer Journal: Eur J Heart Fail Date: 2021-10-10 Impact factor: 17.349