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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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“Clinical inertia, the reluctance to intensify treatment despite suboptimal control, has been shown to significantly impede GDMT application, with over 50% of physicians reducing therapy based on anticipated rather than actual AEs [4].”
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“9 These visits involve clinical assessment with specialized personnel, laboratory measurements, and adjunctive diagnostic modalities, which are resource-intensive and pose a significant burden to specialized outpatient clinics.”
Alradhi, A. A., Shujaa, A.-K., Alsagheer, N. K., Al-Maimoony, T., & Al‐Motarreb, A. (2025) · Heart Views · doi:10.4103/heartviews.heartviews_152_24
Thakkar, R., Peer, M., Patel, A. K., Toor, T., Omar, M. S., Mahmood, M., Haque, M., Singh, J., & Sultan, O. M. (2025) · SN Comprehensive Clinical Medicine · doi:10.1007/s42399-025-02034-8
“The STRONG-HF trial further emphasized that rapid up-titration of GDMT after heart failure admission significantly reduced all-cause mortality at 180 days [17].”
Heart Failure in 2025: Update With Perioperative Considerations
Mendapara, P., Ramakrishna, H., & Stawiarski, K. M. (2025) · Journal of Cardiothoracic and Vascular Anesthesia · doi:10.1053/j.jvca.2025.08.019 · Cited by 1
Integrating and Simplifying Evidence to Optimize Cardiorenal Guideline-Directed Therapies
Singh, H., Puckett, C., & Lucas, Y. Q. (2025) · Journal of Clinical Medicine · doi:10.3390/jcm14165883
“This approach significantly reduced the risk of death or HF readmission [83].”
Dziewięcka, E. M., Holcman, K., Kostkiewicz, M., Szot, W., Wiśniowska‐Śmiałek, S., Winiarczyk, M., Przytuła, N., Stępień, A., Graczyk, K., Mazur, M., et al. (2025) · IJC Heart & Vasculature · doi:10.1016/j.ijcha.2025.101784
Influenza vaccination in heart failure: a shot worth taking?
Bhatt, A. S., & Vardeny, O. (2025) · The Lancet · doi:10.1016/s0140-6736(25)01679-4
Kanaparthy, N. S., Possick, S. E., Teng, W., Maulion, C., & Kim, N. V. (2025) · PLoS ONE · doi:10.1371/journal.pone.0330188
Das Heart-Team bei Herzinsuffizienz
Jozwiak‐Nozdrzykowska, J., Sandri, M., Hanuna, M., Nedios, S., & Dashkevich, A. (2025) · Herz · doi:10.1007/s00059-025-05330-0
“In den letz- tenJahrenhabensichneuemedikamentö-se Therapieoptionen ergeben, welche die Hospitalisierungsrate verringern und die Prognose der Patienten verbessern können [4–11].”
Die ESC-Leitlinien zur Herzinsuffizienz im Spiegel aktueller Evidenz
Ghorani, H. A., Böhm, M., & Abdin, A. (2025) · Kardiologie up2date · doi:10.1055/a-2461-7287
Kutyifa, V., Burch, A. E., Russo, A. M., Beck, C. A., Cuneo, A., Bonderman, D., Perings, C. A., Duncker, D., Winzer, E. B., Hain, A., et al. (2025) · Heart Rhythm O2 · doi:10.1016/j.hroo.2025.09.018
“24 In addition, novel, non-invasive, monitoring strategies to rapidly implement optimal therapy and improve prognosis of these patients could alleviate significant health care costs and burden for both caregivers and patients.”
Raby, J., Aggour, H., George, M., Glatzel, H., Fidock, B., Winter, M., Quek, K., Federman, S., Chaplin, J., Kononen, M., et al. (2025) · Open Heart · doi:10.1136/openhrt-2025-003432
“However, as we found that all LVEF groups benefited from postdischarge HF specialist care, this uncertainty should not detract from the key messages of our study.”
Ray, G. M., Winters, A., Lopez, M., Bos, A. J., Bermudez, S. R., & Anderson, J. R. (2025) · American Journal of Health-System Pharmacy · doi:10.1093/ajhp/zxaf082
Was ist gesichert in der medikamentösen Therapie der Herzinsuffizienz?
Soltani, S., & Bauersachs, J. K. (2025) · Die Innere Medizin · doi:10.1007/s00108-025-01998-y
ACETAZOLAMIDE IN HEART FAILURE: PAST- OR FUTURE-ORIENTED TREATMENT
Serov, V. A., Shiryaevskaya, D. V., Shiryaevskiy, O. A., & Ефремова, Е. В. (2025) · Ulyanovsk Medico-biological Journal · doi:10.34014/2227-1848-2025-3-41-59
Sanusi, M., Ndakotsu, A., Umashankar, D., Nakarmi, P., Vempati, R., Patel, R., Varma, Y., Qadeer, Y. K., Dasari, U., & Krishnamoorthy, G. (2025) · American Journal of Cardiovascular Drugs · doi:10.1007/s40256-025-00772-7
“The STRONG-HF trial demonstrated that rapid GDMT up-titration significantly reduced HF hospitalizations and mortality [13].”
Chang, P.-H., Liao, F., Wu, Y.-C., Sun, F.-J., Liu, Y.-Y., Yeh, H., Hung, C., & Wu, K. (2025) · Frontiers in Artificial Intelligence · doi:10.3389/frai.2025.1664627
Erstversorgung und Stabilisierung von Erwachsenen mit angeborenen Herzfehlern (EMAH)
Franke, K., & Rupp, S. (2025) · Medizinische Klinik - Intensivmedizin und Notfallmedizin · doi:10.1007/s00063-025-01335-z
Navigating acute decompensated heart failure management: as easy as 1, 2, 3?
Rajapakse, S. P., Parvar, S., Gunton, J. E., Burdeniuk, C., & Pasquale, C. G. D. (2025) · Internal Medicine Journal · doi:10.1111/imj.70206
Zhu, W., Xu, J., & Zhang, L. (2025) · American Heart Journal Plus Cardiology Research and Practice · doi:10.1016/j.ahjo.2025.100655
“Some retrospective analyses suggest that continuing or initiating β -blockers early in patients with acute heart failure with acceptable blood pressure is associated with better post-discharge prognosis [33 – 35].”
Beta-blockers in the treatment of heart failure
Špinarová, M., & Lábr, K. (2025) · Klinická farmakologie a farmacie · doi:10.36290/far.2025.059
Therapie der Herzinsuffizienz nach Dekompensation
Tokcan, M., Hoevelmann, J., Markwirth, P., Kulenthiran, S., Kindermann, I., & Böhm, M. (2025) · MMW - Fortschritte der Medizin · doi:10.1007/s15006-025-5307-7
Lin, C.-H., Yan, B. W., YEUNG, V., Davison, B. A., Cotter, G., Pandya, A., & Spahillari, A. (2025) · Journal of Cardiac Failure · doi:10.1016/j.cardfail.2025.10.015
Self-citationLi, Z., Tao, Q., Wu, Y., Hua, S., Li, Q., Wang, Z., Chen, Y., Li, Y., Qiu, Z., & Jin, W. (2025) · Annals of Medicine · doi:10.1080/07853890.2025.2583558 · Cited by 1
“…study demonstrated that rapid up-titration of GDMTs (including ACEI, ARB, ARNI, beta-blocker, and MRA) to target doses lowered the risks of all-cause mortality and rehospitalization in patients with acute HF, with consistent benefits observed in both the LVEF ≤40% and LVEF >40% subgroups [27].”
Logeart, D., Roubille, F., Salvat, M., Tribouilloy, C. M., Bauer, F., Eicher, J., Picard, F., Hunolstein, J. V., Trochu, J., de Groote, P., et al. (2025) · IJC Heart & Vasculature · doi:10.1016/j.ijcha.2025.101833
Galas, A. A., Morawiec, R., Kapłon‐Cieślicka, A., Byczkowska, K., Furmanek, W., Stefański, A., Wożakowska−Kapłon, B., Klimczak‐Tomaniak, D., Hamala, P., Furman-Niedziejko, A., et al. (2025) · Journal of Clinical Medicine · doi:10.3390/jcm14227980
Sim, D., Lin, W., Teo, L. L. Y., Prameswari, H. S., Wong, Y. M., Mebazaa, A., Bader, F. M., Sindone, A. P., Ghazi, A. M., Zhang, Y., et al. (2025) · Journal of Asian Pacific Society of Cardiology · doi:10.15420/japsc.2025.31
Self-citationJensen, H., Staskauskas, M., Strome, S., Pobre, J., Le, N., Nakamura, C., Fahmy, M., Dang, B., Hellier, Y., Shin, J., et al. (2025) · Annals of Pharmacotherapy · doi:10.1177/10600280251387249
Palo, K. E. D., Tiwari, S., & DiDomenico, R. J. (2025) · Journal of Cardiac Failure · doi:10.1016/j.cardfail.2025.11.486
Hypertonie bei Diabetes und Herzinsuffizienz
Soltani, S., & Bauersachs, J. (2025) · Aktuelle Kardiologie · doi:10.1055/a-2708-2174
Jonsson, A., Sharif, S., Birring, E., Karlsson, M., & Lindmark, K. (2025) · BMC Cardiovascular Disorders · doi:10.1186/s12872-025-05384-2
“Patients with LVEF ≤ 40% should be up titrated on maximal tolerated dose after initiation of OMT [6, 10, 22].”
Cook, J., Jiang, J. Q., Khan‐Kheil, A. M., & Ingram, T. E. (2025) · Echo Research and Practice · doi:10.1186/s44156-025-00098-9
“Prompt treatment with well-established and proven therapies [7] has been repeatedly shown in trial data to improve symptoms and quality of life as well as a reduce the risk of all cause death or HF related hospital admissions [8–10].”
Senanayake, S. P., Lee, A. S. Y., Kularatna, S., Win, T. M., Lee, A., Lau, Y. H., Hausenloy, D. J., Yeo, K.-K., Chan, M. Y., Wong, R. C. C., et al. (2025) · SSRN Electronic Journal · doi:10.2139/ssrn.5910009
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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