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Safety, tolerability and efficacy of up-titration of guideline-directed medical therapies for acute heart failure (STRONG-HF): a multinational, open-label, randomised, trial
Open accessAbstract
Background There is a paucity of evidence for dose and pace of up-titration of guideline-directed medical therapies after admission to hospital for acute heart failure.Methods In this multinational, open-label, randomised, parallel-group trial (STRONG-HF), patients aged 18-85 years admitted to hospital with acute heart failure, not treated with full doses of guideline-directed drug treatment, were recruited from 87 hospitals in 14 countries. Before discharge, eligible patients were randomly assigned (1:1), stratified by left ventricular ejection fraction (≤40% vs >40%) and country, with blocks of size 30 within strata and randomly ordered sub-blocks of 2, 4, and 6, to either usual care or high-intensity care. Usual care followed usual local practice, and high-intensity care involved the up-titration of treatments to 100% of recommended doses within 2 weeks of discharge and four scheduled outpatient visits over the 2 months after discharge that closely monitored clinical status, laboratory values, and N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentrations. The primary endpoint was 180-day readmission to hospital due to heart failure or all-cause death. Efficacy and safety were assessed in the intention-to-treat (ITT) population (ie, all patients validly randomly assigned to treatment). The primary endpoint was assessed in all patients enrolled at hospitals that followed up patients to day 180. Because of a protocol amendment to the primary endpoint, the results of patients enrolled on or before this amendment were down-weighted. This study is registered with ClinicalTrials.gov, NCT03412201, and is now complete.Findings Between May 10, 2018, and Sept 23, 2022, 1641 patients were screened and 1078 were successfully randomly assigned to high-intensity care (n=542) or usual care (n=536; ITT population). Mean age was 63·0 years (SD 13·6), 416 (39%) of 1078 patients were female, 662 (61%) were male, 832 (77%) were White or Caucasian, 230 (21%) were Black, 12 (1%) were other races, one (<1%) was Native American, and one (<1%) was Pacific Islander (two [<1%] had missing data on race). The study was stopped early per the data and safety monitoring board's recommendation because of greater than expected between-group differences. As of data cutoff (Oct 13, 2022), by day 90, a higher proportion of patients in the high-intensity care group had been up-titrated to full doses of prescribed drugs (renin-angiotensin blockers 278 [55%] of 505 vs 11 [2%] of 497; β blockers 249 [49%] vs 20 [4%]; and mineralocorticoid receptor antagonists 423 [84%] vs 231 [46%]). By day 90, blood pressure, pulse, New York Heart Association class, bodyweight, and NT-proBNP concentration had decreased more in the high-intensity care group than in the usual care group. Heart failure readmission or all-cause death up to day 180 occurred in 74 (15·2% down-weighted adjusted Kaplan-Meier estimate) of 506 patients in the high-intensity care group and 109 (23·3%) of 502 patients in the usual care group (adjusted risk difference 8·1% [95% CI 2·9-13·2]; p=0·0021; risk ratio 0·66 [95% CI 0·50-0·86]). More adverse events by 90 days occurred in the high-intensity care group (223 [41%] of 542) than in the usual care group (158 [29%] of 536) but similar incidences of serious adverse events (88 [16%] vs 92 [17%]) and fatal adverse events (25 [5%] vs 32 [6%]) were reported in each group.Interpretation An intensive treatment strategy of rapid up-titration of guideline-directed medication and close follow-up after an acute heart failure admission was readily accepted by patients because it reduced symptoms, improved quality of life, and reduced the risk of 180-day all-cause death or heart failure readmission compared with usual care.Funding Roche Diagnostics.
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“Therapy with dapagliflozin 10 mg o.d. vs. placebo reduced the risk of the primary outcome, a composite of worsening HF (hospitalization or an urgent visit resulting in i.v.therapy for HF) or CV death, by 26% (HR 0.74; 95% CI, 0.65-0.85).”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [492]
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“In addition, dapagliflozin reduced all-cause mortality (HR 0.83; 95% CI, 0.71-0.97)and improved symptoms, physical function, and quality of life in patients with HFrEF.491,492”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [492]
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Pagnesi, M., Adamo, M., & Metra, M. (2024) · European Journal of Heart Failure · doi:10.1002/ejhf.3257
“3,5,6 Second, NICE did not use a protocol-based algorithm for optimizing medical therapy, 7 whereas STRONG-HF tested a strategy based on early GDMT up-titration and close follow-up with serial evaluation of multiple safety indicators and pre-specified changes in medications and their doses based on…”
BackgroundMethodInfluentialSelf-citation(Focused on heart failure treatment according to the updated 2023 guidelines)
Brotánek, J. (2024) · Cor et Vasa · doi:10.33678/cor.2024.025
Geavlete, O. D., & Chioncel, O. (2024) · European Journal of Preventive Cardiology · doi:10.1093/eurjpc/zwae162
Self-citationClinical and instrumental diagnosis of heart failure
Pedretti, R. F. E. (2024) · The Journal of AMD · doi:10.36171/jamd24.27.1.7
Hard Work and Talent in the Battle Against Heart Failure
Baran, D. A., & Snipelisky, D. (2024) · JACC Heart Failure · doi:10.1016/j.jchf.2024.04.005
Bakhsh, A., Jelaidan, I., Chaudhary, A., Amro, S. A., Alghalayini, K. W., Almogbel, O., Alqaseer, M., Albackr, H. B., Elshaer, F., & Ayoubi, F. A. (2024) · Journal of the Saudi Heart Association · doi:10.37616/2212-5043.1375
“Intensifying medical therapy within 90 days of worsening HF signi fi - cantly reduces the HF symptoms and the level of natriuretic peptides (NPs) [41].”
BackgroundInfluentialDon’t Put Too Much Weight on Weight Telemonitoring in High-Risk Heart Failure Patients!
Angermann, C. E. (2024) · European Journal of Heart Failure · doi:10.1002/ejhf.3346
Vardeny, O., & Cotter, G. (2024) · JACC Heart Failure · doi:10.1016/j.jchf.2024.05.013
Self-citationAdvances in detection, prevention and treatment of heart failure in type 2 diabetes: part II
Cowley, A., Dattani, A., Brady, E. M., McCann, G. P., & Gulsin, G. S. (2024) · British Journal of Diabetes · doi:10.15277/bjd.2024.442
Managing Heart Failure in Chronic Kidney Disease: A Review of Current Literature
Lidgard, B., & Bansal, N. (2024) · Current Treatment Options in Cardiovascular Medicine · doi:10.1007/s11936-024-01048-0 · Cited by 1
“%) and MRAs (84% versus 46%), and NYHA class and NT-proBNP concentrations decreased more in the aggressive care group than in the typical care group [78].”
Experimental Designs for Multicomponent Interventions in Kidney and Cardiometabolic Diseases
Rossing, P. R. (2024) · Journal of the American Society of Nephrology · doi:10.1681/asn.0000000000000449
Simplifying Treatment of Congestion
Boorsma, E. M., Docherty, K. F., & Campbell, R. T. (2024) · JACC Heart Failure · doi:10.1016/j.jchf.2024.05.024
Meng, F., Zhu, Y., & Yang, M. (2024) · Medical & Biological Engineering & Computing · doi:10.1007/s11517-024-03174-0
Improving the rate of heart failure with improved ejection fraction
Giannitsis, E., Frey, N., & Jhund, P. S. (2024) · European Journal of Heart Failure · doi:10.1002/ejhf.3427
Васильевна, Ц. О., Apartseva, N. E., Latyntseva, L. D., Polonskaya, Y. V., & Kashtanova, E. V. (2024) · CARDIOVASCULAR THERAPY AND PREVENTION · doi:10.15829/1728-8800-2024-4100
Highlighting the latest research: August 2024
Bernhardt, L., & Thomas, A. (2024) · British Journal of Cardiac Nursing · doi:10.12968/bjca.2024.0050
Heart Failure with Reduced Ejection Fraction and COVID-19, when the Sick Get Sicker
Contreras, J., Tinuoye, E. O., Folch, A., Aguilar, J., Free, K., Ilonze, O. J., Mazimba, S., Rao, R. A., & Breathett, K. K. (2024) · Heart Failure Clinics · doi:10.1016/j.hfc.2024.06.002
Metadata
- Authors
- Mebazaa, A., Davison, B., Chioncel, O., Cohen-Solal, A., Diaz, R., Filippatos, G., Metra, M., Ponikowski, P., Sliwa, K., Voors, A. A., Edwards, C., Novosadova, M., Takagi, K., Damasceno, A., Saidu, H., Gayat, E., Pang, P. S., Celutkiene, J., & Cotter, G.
- Affiliations
- Inserm (FR)
- Carol Davila University of Medicine and Pharmacy (RO)
- National and Kapodistrian University of Athens (GR)
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (IT)
- Wroclaw Medical University (PL)
- University of Cape Town (ZA)
- University Medical Center Groningen (NL)
- Momentum Research (US)
- Eduardo Mondlane University (MZ)
- Bayero University Kano (NG)
- Indiana University Indianapolis (US)
- Corresponding author
- Mebazaa, Alexandre
- ORCID
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2022-12
- Volume
- 400
- Issue
- 10367
- Pages
- 1938-1952
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- OpenAlex
- W4308471536
- Cited by
- 1,123
- References
- 32
- Citations by year
- 2026: 293 · 2025: 311 · 2024: 289 · 2023: 223 · 2022: 6
- FWCI
- 144.33
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- www.elsevier.com/tdm/userlicense/1.0/ (tdm)
- www.elsevier.com/legal/tdmrep-license (tdm)
- www.elsevier.com/open-access/userlicense/1.0/ (am, 182 d)
- doi.org/10.15223/policy-017 (stm-asf)
- doi.org/10.15223/policy-037 (stm-asf)
- doi.org/10.15223/policy-012 (stm-asf)
- doi.org/10.15223/policy-029 (stm-asf)
- doi.org/10.15223/policy-004 (stm-asf)
- Locations
- The Lancet (acceptedVersion)
- PubMed (publishedVersion)
- IUScholarWorks (Indiana University) (submittedVersion)
- HAL (submittedVersion)
- Institutional Research Information System (Università degli Studi di Brescia) (submittedVersion)
- Archivio Istituzionale della Ricerca - Università Vita-Salute San Raffaele (submittedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion, other-oa)
- Funders
- Roche Diagnostics Corp
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart Failure Treatment and Management
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart rate and cardiovascular health
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Acute Myocardial Infarction Research
- Keywords
- acute heart failure, guideline-directed medical therapy, high-intensity care, heart failure readmission, all-cause mortality, NT-proBNP, left ventricular ejection fraction, outpatient monitoring, hospital discharge, drug safety and tolerability, heart failure pharmacotherapy
- MeSH terms
- Mineralocorticoid Receptor Antagonists, Female, Heart Failure, Humans, Male, Middle Aged, Quality of Life, Stroke Volume, Ventricular Function, Left, Treatment Outcome
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