Safety, tolerability, and efficacy of guideline-based augmentation of medical therapies in acute heart failure (STRONG-HF). multi-national, open, randomized, trial

Safety, tolerability, and efficacy of guideline-based augmentation of medical therapies in acute heart failure (STRONG-HF). multi-national, open, randomized, trial

Background:

There is little evidence for guideline-based dosing and titration rates of medical therapies after hospital admission for acute heart failure.

Methods:

In this multinational, open-label, randomized, parallel-group trial (STRONG-HF), 87 patients aged 18-85 years admitted to the hospital with acute heart failure who were not treated with full-dose guideline-recommended drug therapy were recruited. hospitals in 14 countries. Before discharge, eligible patients were randomly assigned (1:1), stratified by left ventricular ejection fraction (≤40%). vs >40%) and country in strata with blocks of size 30 and randomly ordered subblocks of 2, 4, and 6 for usual care or high-intensity care. Usual care followed usual local practice, and high-intensity treatment included treatment titration to 100% of recommended doses within 2 weeks of discharge and four scheduled outpatient visits within 2 months of discharge, closely monitoring clinical status, laboratory values , and N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentrations. The primary endpoint was 180-day hospital readmission for heart failure or all-cause death. Efficacy and safety were assessed in the intention-to-treat (ITT) population (ie, all patients were randomized to treatment). The primary endpoint was assessed in all patients enrolled in hospitals that followed patients through day 180. Because of a protocol change in the primary end point, outcomes in patients enrolled before this change or before it were weighted less. This study is registered ClinicalTrials.gov, NCT03412201and is now complete.

Findings

Between May 10, 2018 and September 23, 2022, 1,641 patients were screened, and 1,078 were successfully randomized to high-intensity care (n=542) or usual care (n=536; ITT population). Mean age was 63.0 years (SD 13.6), of 1078 patients, 416 (39%) were female, 662 (61%) were male, and 832 (77%) were white or Caucasian, 230 (21%) Black. , 12 (1%) were other races, one (<1%) Native American, and one (<1%) Pacific Islander (two [<1%] had missing data on race). The study was stopped early at the recommendation of the data and safety monitoring board due to larger than expected differences between the groups. By the end of the data (October 13, 2022), by day 90, a greater proportion of patients in the high-intensity care group had been titrated to full doses of prescribed medications (renin-angiotensin blockers 278). [55%] from 505 vs 11:00 [2%] from 497; β blockers 249 [49%] vs 20:00 [4%]; and mineralocorticoid receptor antagonists 423 [84%] vs 231: [46%]) at 90 days, blood pressure, pulse, New York Heart Association class, body weight, and NT-proBNP concentration decreased more in the high-intensity care group than in the usual care group. Heart failure readmission or all-cause death by day 180 occurred in 74 of 506 patients in the high-intensity care group (15.2% decrement weighted adjusted Kaplan-Meier estimate) and 109 of 502 patients (23.3%) : in the usual care group (adjusted risk difference 8.1% [95% CI 2·9–13·2]; p=0·0021; hazard ratio 0·66
[95% CI 0·50–0·86]) more adverse events occurred at 90 days in the high-intensity care group (223 [41%] 542) than in the usual care group (158 [29%] 536), but similar incidence of serious adverse events (88 [16%] vs 92: [17%]) and fatal adverse events (25 [5%] vs 32:00 [6%]) were presented in each group.

comment

An intensive treatment strategy of rapid guideline-directed drug titration and close follow-up after acute heart failure was readily accepted by patients because it reduced symptoms, improved quality of life, and reduced 180-day all-cause death or heart failure readmission compared with usual care.

Funding

Roche Diagnostics.



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