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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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In the citing paper
“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]
Experimental — accuracy not yet measuredIn the citing paper
“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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InfluentialEmpagliflozin in De Novo vs Acute Decompensated Chronic Heart Failure
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Self-citationExperts’ recommendations for the management of adult patients with cardiogenic shock
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BackgroundCardiopulmonary Exercise Testing in the Age of New Heart Failure Therapies: Still a Powerful Tool?
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“Importantly, the increasing regular follow-up by a dedicated HF team, implementing rapid up-titration of medical therapy after diagnosis [10], cardiac rehabilitation programs [25], improved transitional care interventions [11,26], and close follow-up after an HF hospitalization or an urgent visit for IV diuretics have…”
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Az új jelszó a csökkent ejekciós frakcióval járó szívelégtelenség bázisterápiájában: ASAP!
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“These four foundational therapies should be initiated early, and recent data suggest that an early up-titration within 6 weeks improves the prognosis compared to a standard approach [23].”
BackgroundHow Can Biomarkers Be Useful in the Management of Acute Heart Failure?
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“9 In addition to the limitation of the gray zone, other limitations must also be taken into account when interpreting the results of NP. 10 Some variables influence their levels.”
BackgroundUnderstanding medication adherence in patients with heart failure: commentary
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“4,6 The decision to initiate multiple agents at the same time is primarily driven by individual patient characteristics such as baseline blood pressure, renal function, volume status, electrolytes, comorbidities, etc. 1,4 Among the available agents used for GDMT, the safety of combining ARNI with…”
How to Optimize Goal-Directed Medical Therapy (GDMT) in Patients with Heart Failure
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“It found reduced symptoms and improved quality of life with reduced risk of death or readmission at 180 days in the treat-ment group [41].”
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“13 Furthermore, according to a meta-analysis, the combination of 4 HF medications (SV, beta-blockers, MRA, and SGLT2i) prolongs survival compared with the combination of ACEi/ARB and beta-blockers.”
Aissaoui, H., Pichard, S., Gaulupeau, V., Gautron, E., Wajchert, T., Assayag, F., Gilles, F., Duvillier, P., Georges, J., & Gibault‐Genty, G. (2024) · Annales de Cardiologie et d Angéiologie · doi:10.1016/j.ancard.2024.101802 · Cited by 2
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Lam, P. H., Liu, K., Ahmed, A. A., Butler, J., Heidenreich, P. A., Anker, M. S., Faselis, C. J., DEEDWANIA, P. C., Aronow, W. S., Kanonidis, I. E., et al. (2024) · The American Journal of Medicine · doi:10.1016/j.amjmed.2024.10.015 · Cited by 2
Tanaka, A., Imai, T., Kida, K., Matsue, Y., Node, K., & the PREMIER Study Investigators (2024) · European Journal of Heart Failure · doi:10.1002/ejhf.3526 · Cited by 2
A STRONG call for intensive oral heart failure therapy in acute heart failure patients
Clarkson, S. A., Lund, L. H., & Mebazaa, A. (2025) · Heart Failure Reviews · doi:10.1007/s10741-025-10486-2 · Cited by 2
“In fact, the trial was stopped earlier due to greater than expected benefit of the treatment arm further strengthening the evidence for structured, intense, and focused titration of medical therapy [20].”
InfluentialSelf-citationInstabile Herzinsuffizienz: Wie lassen sich häufige Krankenhausaufnahmen vermeiden?
von Haehling, S., Aßmus, B., Frantz, S., Störk, S., Wachter, R., Schulze, P. C., & Bauersachs, J. K. (2025) · DMW - Deutsche Medizinische Wochenschrift · doi:10.1055/a-2447-7654 · Cited by 2
Closing the GDMT gap: insights from PHARM-HF A&F on the role of pharmacists in heart failure care
Zheng, J. (2025) · Heart Failure Reviews · doi:10.1007/s10741-025-10496-0 · Cited by 2
“Pharmacist-led rapid uptitration programs may be a scalable alternative to physician-led titration, particularly in resource-limited settings [7].”
Isath, A. M., & Panza, J. A. (2025) · Progress in Cardiovascular Diseases · doi:10.1016/j.pcad.2025.04.001 · Cited by 2
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Philbin, S. E., Gleason, L. P., Persell, S. D., Walter, E., Petito, L. C., Tibrewala, A., Yancy, C. W., Beidas, R. S., Wilcox, J. E., Mutharasan, R. K., et al. (2025) · Journal of General Internal Medicine · doi:10.1007/s11606-025-09515-5 · Cited by 4
“35 Although some implementation strategies have been led to improvements in the uptake of quadruple therapy, 11,32,45–48 none, to our knowledge, has prioritized reaching patients who primarily receive care in FQHCs.”
Heart Failure with Reduced Ejection Fraction
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Practical Pharmacological Treatment of Heart Failure: Does Ejection Fraction Matter Anymore?
Chan, J. C. H., Cowley, E. C., & Chan, M. C. Y. (2023) · Journal of Cardiovascular Development and Disease · doi:10.3390/jcdd10030114 · Cited by 2
“In addition, the STRONG-HF trial demonstrated patient concordance that intensive treatment and rapid up-titration of GDMT improved quality of life and reduced mortality, readmission and symptoms [60].”
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Self-citationPatient-Centered Heart Failure Therapy
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Functional Mitral Regurgitation
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Clinical Outcomes With Electronic Nudges to Increase Influenza Vaccination
Johansen, N. D., Vaduganathan, M., Bhatt, A. S., Lee, S. G., Modin, D., Claggett, B. L., Dueger, E. L., Samson, S., Loiacono, M. M., Harris, R. C., et al. (2024) · Annals of Internal Medicine · doi:10.7326/m23-2638 · Cited by 2
Remote monitoring in heart failure: it’s the data you collect and what you do with them
Straw, S., & Witte, K. K. (2023) · Heart · doi:10.1136/heartjnl-2022-322137 · Cited by 2
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Using Combinational Diuretics Across the Spectrum of Renal Function
Martens, P., & Müllens, W. (2023) · European Journal of Heart Failure · doi:10.1002/ejhf.3030 · Cited by 2
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Rapid Uptitration of Guideline-Directed Medical Therapy Regardless of Risk
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Where Are All the Heart Failure GDMT Clinics?
Page, R. L., II, & Khazanie, P. (2025) · JACC Heart Failure · doi:10.1016/j.jchf.2025.01.010 · Cited by 2
Guideline-Directed Medical Therapy in Heart Failure
Xiang, M. (2025) · JACC Asia · doi:10.1016/j.jacasi.2025.03.004 · Cited by 2
The heart failure and diabetes combo: higher risk, less care?
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Simultaneous or Rapid Sequence Optimization of Medical Therapy for Heart Failure: Time to Keep Score
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Implementation of Guidelines in Heart Failure: Problems and Potential Solutions
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Advances in Cardiorenal Medicine: The Year 2024 in Review
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Performance and opportunity: retrospective cohort study of general medicine heart failure management
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Mortality and Economic Impact of Heart Failure
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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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