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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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“In fact, this early period of titration represents a key window for rapid optimization of GDMT, as demonstrated in the STRONG-HF trial [12]; however, clinical instability and comorbidities such as renal impairment frequently hinder treatment titration [13].”
Bridging the Heart Failure Postdischarge Gap With Artificial Intelligence
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“Abrupce placenty 0,88 (0,49 – 1,59) 20/1170 (1,7) 22/1155 (1,9) 0,90 (0,49–1,64) Úmrtí plodu nebo novorozence < 28 dnů 0,81 (0,54–1,22) 41/1170 (3,5) 50/1155 (4,3) 0,81 (0,54–1,21)”
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Will the results from the AdaptResponse trial boost CRT use?
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Kardiovaskuläre Therapie bei chronischer Nierenerkrankung
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“17 GDMT optimization has unequivocal benefits in HF outcomes.”
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Advances in Cardiology in 2023
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The results of a survey: "Diagnosis and treatment of heart failure in the clinical practice"
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“In this regard, the STRONG-HF trial demonstrated that in patients with HF, an “intensive treatment” leads to a greater reduction, compared to the “standard treatment,” of death from all causes and hospitalization for HF [6].”
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Characteristics, treatment, and outcomes of early vs. late enrollees of the STRONG-HF trial
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Treatment of advanced heart failure
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What's New in Heart Failure? June–July 2024
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The War Against Heart Failure Hospitalizations
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Heart Failure in Older People Part 2: Guideline-Directed Medical Therapy
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Cardiovascular Precision Medicine and Remote Intervention Trial Rationale and Design
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“Indeed, a recent trial showed that optimizing the use of existing medications (rather than employing new ones), in the absence of any financial support, can have a profound effect on the success of treatment for cardiovascular illness in diverse populations worldwide [46].”
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“…2 days before anticipated hospital discharge) not only reduced readmissions for HF or all-cause mortality but significantly improved patients’ HRQoL within 6 months [53], supporting adopting intensive GDMT with rapid up-titration and close follow-up in patients hospitalised due to worsening of HF.”
Identifying Patients with Heart Failure Eligible for Guideline-Directed Medical Therapy
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“19 Protocolized visits with cardiologists and interventions based on multidisciplinary teams have been found to have a better impact than clinician alerts or quality initiatives that focus on education and audit-feedback processes alone.”
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“STRONG-HF has previously demonstrated the benefits of high-intensity uptitration of HF GDMT, irrespective of baseline LVEF, and thus the information provided by remote PAP monitoring should act as a tool to help optimise HF GDMT use in the future [28].”
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Collaborative Management of Hyperkalemia in Patients with Complex Heart Failure
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“Numerous experts have proposed algorithms for managing these treatments, often involving the combination of at least three types of medications and aiming for high GDMT doses as close as possible to the target doses [14–16].”
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“The need for a strategy to ensure prompt identification, referral, and treatment of GMDT is supported by the STRONG-HF study 46 .”
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“Conversely, as early and rapid initiation of guideline-directed medical therapy improves the prognosis of patients with HF [14,29], active initiation of sacubitril/valsartan therapy in patients with lower MAGGIC risk scores, where the risk of DAEs appears to be lower, may be considered beneficial.”
Less Heart Failure But No Improvement in Quality of Life in FINEARTS-HF
Cotter, G., Davison, B. A., & Bhatt, D. L. (2025) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2025.04.022 · Cited by 1
Self-citationHeart Failure with Preserved Ejection Fraction in the Indian Context
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“Contemporary trials have confirmed the substantial benefits of rapid and thorough GDMT optimization on heart failure outcomes [25] and the anti-arrhythmic effects of heart failure GDMT in preventing ventricular arrhythmias and sudden cardiac death [26].”
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“This finding further support and complement the STRONG-HF trial, 7 which underscored the importance of guideline-directed early initiation and rapid optimization during hospitalization.”
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Setting the Diagnosis of Heart Failure
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Optimizing Background Therapy for Heart Failure in Clinical Trials
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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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