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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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Establishing four pillar treatment of chronic heart failure
Roskvist, R. P., Johnston, R., Eggleton, K. S., & Arroll, B. (2026) · BMJ · doi:10.1136/bmj.s450
Gergely, T. G., Forrai, Z., Kazay, Á., Schäffer, P. P., Vámos, M., Pilecky, D., Füzesi, T. P., Hanuska, L. F., Nyolczas, N., Dékány, M., et al. (2026) · Clinical Research in Cardiology · doi:10.1007/s00392-026-02865-y
“Moreover, according to the STRONG-HF trial [43], rapid up-titration of GDMT is of strategic importance [44–46].”
Kanaoka, K., Nakoji, T., Takegawa, K., Ishihara, S., Nasu, T., Fujimoto, W., Kagiyama, N., Shiraishi, Y., Ishii, S., Ijichi, T., et al. (2026) · Journal of Cardiology · doi:10.1016/j.jjcc.2026.03.006
Zhu, W., & Xu, J. (2026) · American Heart Journal Plus Cardiology Research and Practice · doi:10.1016/j.ahjo.2026.100768
Heart failure: an overview of the causes, symptoms, diagnosis and treatment
Hyland, R. A., Donnelly, E., Briggs, A., Collier, L., & Rose, H. (2026) · Nursing Standard · doi:10.7748/ns.2026.e12662
Nguyen, H. T., Nguyen, H. T. M., Nguyen, K. D. P., & Tran, D. T. (2026) · Journal of Cardiovascular Pharmacology and Therapeutics · doi:10.1177/10742484261438177
International Utah Cardiac Recovery Symposium (U-CARS) 2025: Clinical Science Proceedings
Kyriakoulis, I., Nickel, I. C., Kanwar, M. K., Hanff, T. C., Stehlik, J., Selzman, C. H., & Drakos, S. G. (2026) · Heart Failure Reviews · doi:10.1007/s10741-026-10621-7
Natriuretic peptides—a screening tool for heart failure?
Peters, C., & Rocca, H. B. (2026) · European Heart Journal - Quality of Care and Clinical Outcomes · doi:10.1093/ehjqcco/qcag053
Kozhevnikova, M. V., Emelyanov, A. V., Анатольевна, Ж. Е., Pavlov, N. A., Khabarova, N. V., & Belenkov, Y. N. (2026) · Kardiologiia · doi:10.18087/cardio.2026.2.n3105
Jeewa, A., Flórez, I. D., Cuello-Garcia, C., Laroussi, N. A., Altamirano‐Diaz, L., Armstrong, K., Ashkanase, J., Cunningham, C., Dhillon, S., Dipchand, A. I., et al. (2026) · Canadian Journal of Cardiology · doi:10.1016/j.cjca.2025.12.035
Margaryan, R., Sepehrvand, N., Ouwerkerk, W., Tromp, J., Turgeon, R. D., & Ezekowitz, J. A. (2026) · Circulation Heart Failure · doi:10.1161/circheartfailure.126.014375
Kardiovaskuläre Pharmakotherapie im Zeitalter RNA-basierter Präzisionsmedizin
Derda, A. A., & Hohneck, A. L. (2026) · Herz · doi:10.1007/s00059-026-05375-9
From evidence to adoption: lessons from the OPTIPHARM-HF registry
Störk, S., & Aßmus, B. (2026) · European Journal of Heart Failure · doi:10.1093/ejhf/xuaf011
Wang, X., Zhao, Z., Mao, J., Deng, Y., Liu, Z., 王肖龙, Zhao, Y., Dai, X., Wang, Y., Yuan, R., et al. (2026) · Phytomedicine · doi:10.1016/j.phymed.2026.158191
Kong, M. G., Moon, I., Suh, J., Choi, J. Y., Na, J. O., Yong, H., Shim, C. Y., Park, S.-M., & Kim, E. J. (2026) · ESC Heart Failure · doi:10.1093/eschf/xvag106
“22 Similarly, this study suggests that proactive monitoring and timely intervention may contribute to better symptom management and improved clinical outcomes in patients with chronic HF.”
Jurczyk, D., Paschke, L. M., Below, M., Mezger, M., Piatek, K., Gedeon, N., Lemmer, F., Rawish, E., Fatum, C., Eitel, I., et al. (2026) · International Journal of Cardiology · doi:10.1016/j.ijcard.2026.134510
Brandenburg, V. (2026) · Nephrologie aktuell · doi:10.1055/a-2748-5190
Vijayasimha, M., Srikanth, M., & Mahapatra, C. (2026) · Cardiology Discovery · doi:10.1097/cd9.0000000000000192
Greene, S. J., Bali, V., Coyle, C. R., Obi, E. N., Stevenson, A. S., Done, N., Nason, I., Song, Y., Shen, P., Zhu, A., et al. (2026) · American Heart Journal Plus Cardiology Research and Practice · doi:10.1016/j.ahjo.2026.100786
“…demonstrated that a high-intensity care strategy involving rapid up-titration of GDMT within 2 weeks of discharge and close post-discharge follow-up significantly reduces the composite of 180-day all-cause death or HF readmission compared with usual care (risk ratio 0.66; 95% CI, 0.50 – 0.86) [19].”
InfluentialPrise en charge périopératoire du patient insuffisant cardiaque
Moreau, A., Mhenni, R., Plaud, B., Deniau, B., & Maaouia, C. B. (2026) · Le Praticien en Anesthésie Réanimation · doi:10.1016/j.pratan.2026.04.003
SGLT2 inhibitors for acute heart failure: Efficacy established, but for whom and when?
Song, J. (2026) · European Journal of Internal Medicine · doi:10.1016/j.ejim.2026.106884
Leidi, A., Mann, T., Gosselin, P., Bedulli, M., Esposito, F., Schneider, C., Parent, T., Combescure, C., Desmettre, T., Reny, J., et al. (2026) · Trials · doi:10.1186/s13063-026-09701-8
“Early contrast of neuro-humoral imbalance with chronic heart failure therapies is needed to achieve long-term decongestion [39, 40].”
Pandey, B. P., Ray, S., Kumar, S., Guha, S., Desai, B., Shah, M., Kudva, S., Chopra, V., Agarwal, R., Rastogi, V., et al. (2026) · Cureus · doi:10.7759/cureus.107772
“…opinion [21,47] Policymaker Improved affordability and accessibility; reduced out-of-pocket cost burden for patients in resource-limited settings [21,47] Develop and maintain a national heart failure registry to generate India-specific real-world data on GDMT utilisation, barriers, outcomes, and…”
InfluentialCox, K. J., Darden, B., Parag, B., Ramos, M., Johns, M. L., Nguyen, J., Rupert, C., Funderburk, D., Smith, D., Craver, K., et al. (2026) · Journal of the American Pharmacists Association · doi:10.1016/j.japh.2026.103120
Antonelli, G., Pinto, G., Villaschi, A., Filiberti, G., Levra, A. G., Panico, C., Pagliaro, B., Maccallini, M., Pellegrino, M., Monaco, G. D., et al. (2026) · Internal and Emergency Medicine · doi:10.1007/s11739-026-04355-5
“…frequent cardiology visits and rapid up-titration of GDMT—significantly reduces mid-term all-cause mortality and AHF-related readmissions in patients hospitalized for AHF, with such effect possibly explained by the intensity of follow-up rather than GDMT uptitration alone [3, 22].”
Lundgren, S. W., Diederich, T., Lyden, E. R., Nohl, J., Alonso, W., Pozehl, B., & Burdorf, A. F. (2026) · The American Journal of Cardiology · doi:10.1016/j.amjcard.2026.05.007
Son, J., Cho, D. H., Kim, S., Choi, J. O., Choi, D., Cho, H., Lee, C., Choi, J. O., Lee, S. E., Kim, E. J., et al. (2026) · Journal of the American Heart Association · doi:10.1161/jaha.125.044747
“21 Similarly, structured telephone consultations did not include direct medication-related questions but may have promoted patient engagement, timely reporting of symptoms, and adherence to follow-up visits, thereby creating more opportunities for clinicians to optimize GDMT. 28 However, it is also possible that patie…”
InfluentialIsnard, R., Roubille, F., Doublet, M., Kadri, M., Marinier, K., & Logeart, D. (2026) · Archives of cardiovascular diseases · doi:10.1016/j.acvd.2026.04.002
Alghuthmi, F. A., Haddash, R. S., Alsheikh, E. O., Sannan, Q. H., Alharbi, M. M., Alharbi, J. F., Basranh, Q. H., Alsubhi, A. A., Almuzaini, O. K., & Wali, S. M. (2026) · Frontiers in Medicine · doi:10.3389/fmed.2026.1807201
Oliva, F. G., Orso, F., Basile, C., Colivicchi, F., Cipriani, M., Lenarda, A. D., Gori, M., Gorini, M., Iacoviello, M., Gonzini, L., et al. (2026) · European Journal of Internal Medicine · doi:10.1016/j.ejim.2026.106860
Cohen, A. A., Lang, S., Soulat-Dufour, L., Brito, E., Gerard, M., Mazuyer, M., Ocokoljic, E., Laperche, T., Georges, J., Diakov, C., et al. (2026) · Archives of cardiovascular diseases · doi:10.1016/j.acvd.2026.03.124
Logeart, D., Alos, B., Legallois, D., Clerfond, G., Costa, J., Puymirat, É., Turlotte, G., Thuaire, C., Picard, F., Jondeau, G., et al. (2026) · Heart · doi:10.1136/heartjnl-2025-327454 · Cited by 1
Against the odds: improving survival in acute heart failure
Čelutkienė, J. (2026) · Heart · doi:10.1136/heartjnl-2026-328004
Cerebrovascular disease: clinical, diagnostic and therapeutic approach to stroke
Erhardt, G. A., & Taborda, M. (2024) · International Journal of Neurology · doi:10.62486/ijn2024150
“(46,47) The discrepancy between the established ischemic area visible on diffusion imaging and the perfusion deficit defines the penumbra, which can be used as a marker to predict the potential expansion of the infarct.”
Chronic Kidney Disease in Cardiovascular Pathologies
Obrișcă, B., & Ismail, G. (2026) · Springer eBooks · doi:10.1007/978-3-032-25434-4_4
Yoon, M., & Park, J. J. (2026) · Korean Circulation Journal · doi:10.4070/kcj.2026.0111
The spectrum of congestion in heart failure: underlying pathophysiology and diagnostic strategies
Palazzuoli, A., Beltrami, M., Geavlete, O. D., Ruocco, G. M., Kobayashi, M., Susini, F., Carlino, I., Schirò, G., Ambrosy, A. P., & Chioncel, O. (2026) · Heart Failure Reviews · doi:10.1007/s10741-026-10639-x
“Notably, The STRONG trials demonstrated that both treatment optimization associated with intense surveillance during the post discharge phase reduces the risk for adverse events improving guidelines directed medical therapy [102 ].”
Self-citationEstevan, A. O., Silva, A. L. G. D. F. E., Rassi, S., de Freitas, A. D., & Rassi, S. (2025) · ABC Heart Fail Cardiomyop · doi:10.36660/abchf.20250018i
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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