Risultati per: Scompenso Cardiaco. Gestione in MG dalla diagnosi al follow-up

Circulation, Volume 150, Issue Suppl_1, Page A4134668-A4134668, November 12, 2024. Background:Obstructive sleep apnoea (OSA) is a significant cause of hypertension. ACC/AHA Guidelines recommended screening and treatment of OSA in patients with hypertension; however, evidence comparing mandibular advancement devices (MAD) to continuous positive airway pressure (CPAP) on cardiovascular health is lacking. We present the complete 12 months follow-up data on the comparative effectiveness of MAD versus CPAP in ambulatory BP reduction, QoL, cardiac arrhythmia, and myocardial remodelling.Method:In a randomized, non-inferiority trial (margin 1.5 mmHg), 321 participants, aged over 40, with hypertension and high cardiovascular risk were recruited. Of these, 220 participants with OSA (apnoea–hypopnea index ≥15 events/h) were randomized to either MAD or CPAP (1:1). Pre-specified secondary outcomes include: ambulatory BP, quality of life (QoL) (sleep-specific: ESS, SAQLI, FOSQ; non-sleep-specific: SF-36, EQ-5D), ambulatory ECG monitoring, and cardiac MRI.Results:A total of 89 (80.9% of 110) participants from MAD, and 91 (82.7% of 110) participants from CPAP completed 12 months follow-up. The median daily usage was 5.5 hours for MAD and 4.9 hours for CPAP. The between-group difference in 24h mean BP from baseline to 12 months was – 0.57 mmHg (95% confidence interval: (-2.53 to 1.39, non-inferiority P < 0.001). Compared with the CPAP group, MAD group demonstrated a larger reduction in all the 24h with the most pronounced differences observed in the asleep BP parameters (Table 1). Both the MAD and CPAP improved QoL (Table 2). CPAP had greater improvement in FOSQ from sleep-specific questionnaires (P=0.038), and social QoL in SF-36 from non-sleep-specificl questionnaires (P=0.013). The ambulatory ECG monitoring (MAD: 2.8 ± 1.0 days, CPAP: 2.3 ± 1.1 days) showed no between-group differences in % atrial fibrillation(P=0.209), % ventricular ectopic isolated count (P=0.790) and % supraventricular ectopic isolated count (P= 0.333). The cardiac MRI sub-study (101 participants : MAD= 45, CPAP= 56) showed CPAP had greater improvement in right ventricular stroke volume (P=0.023) and MAD had greater improvement in circumferential strain favours the MAD group (P=0.015) (Table 3).Conclusion:At 12 months , MAD was non-inferior to CPAP for reducing 24h mean arterial BP. MAD showed greater reduction in 24h BPs, especially during asleep. While both the MAD and CPAP are effective in improving QoL, CPAP is more effective in improving FOSQ and social QoL (SF-36).

Circulation, Volume 150, Issue Suppl_1, Page AOr108-AOr108, November 12, 2024. Background:Addition of resuscitative endovascular balloon occlusion of the aorta (REBOA) to automated head-up position (AHUP) cardiopulmonary resuscitation (CPR), the combination of active compression decompression CPR, an impedance threshold device, and controlled gradual elevation of the head and thorax, increases cerebral perfusion pressure. Optimal management of REBOA deflation after prolonged AHUP-CPR and ROSC is unknown.Hypothesis:We hypothesized that partial deflation of REBOA, rather than full deflation after ROSC, would result in better hemodynamic parameters.Aims:To compare hemodynamic parameters 1 minute before and 1 minute after complete (100%) versus partial (50%) REBOA deflation after prolonged AHUP-CPR and ROSC.Methods:Yorkshire pigs weighing ∼40 kg were anesthetized and ventilated. After 10 minutes of untreated ventricular fibrillation, AHUP-CPR was started and continued for a median time of 44 minutes. After ROSC, REBOA deflation was initiated in two ways: complete (100%) or partial (50%) deflation over 5 seconds. The following hemodynamic parameters were measured 1 minute before and 1 minute after deflation: mean aortic pressure (MAP), cerebral perfusion pressure (CerPP), and coronary perfusion pressure (CorPP). Data, in mmHg, are presented as mean ± SD, and compared using a paired t-test.Results:13 pigs were included, with 8 pigs in the 100% deflation group and 5 in the 50% deflation group. After ROSC in the 100% deflation group, MAP was 81.5±36.0 before deflation vs. 43.0±14.4 after (p=0.01), whereas in the 50% deflation group, MAP was 90.5±33.0 vs. 83.4±33.3 (p=0.02). CerPP was 72.3±34.4 before deflation vs. 35.9±14.6 (p=0.01) in the 100% deflation group, and 84.6±31.2 vs. 77.6±31.8 (p=0.02) with 50% deflation. Similarly, CorPP was 74.1±37.3 before deflation vs. 36.1±15.8 (p=0.01) after in the 100% deflation group, and 83.0±32.7 vs. 76.1±33.0 (p=0.02) in the 50% deflation group. The differences from before to after deflation were markedly less in the 50% deflation group versus the 100% deflation group: MAP (7.0±4.3 vs. 38.5±25.7, p=0.02), CerPP (7.1±4.4 vs. 36.3±24.4, p=0.02), and CorPP (6.0±4.2 vs. 39.8±25.2, p=0.02), respectively.Conclusion:In this porcine model of prolonged cardiac arrest, partial deflation of the REBOA balloon post ROSC resulted in strikingly higher hemodynamics compared with complete deflation. These findings highlight the need to develop a post-ROSC REBOA deflation strategy when used during AHUP-CPR.

Circulation, Volume 150, Issue Suppl_1, Page A4140648-A4140648, November 12, 2024. Introduction:Myocardial Infarction with non-obstructive coronary arteries (MINOCA) falls on one end of the spectrum of acute myocardial infarction (AMI) and obstructive coronary disease (OCD) falls on the other end. The pathophysiologic mechanisms behind MINOCA include microvascular dysfunction, coronary spasm and plaque rupture without significant luminal obstruction. Despite its apparent benign anatomical findings, it is associated with major adverse cardiovascular events (MACE). Therapeutic strategies to mitigate the risk of MACE are less defined for MINOCA as compared to OCD. Due to various pathological mechanisms behind MINOCA, it is not certain that the classical medical strategies are optimal therefore there is a dire need for a standardized medical management for this subset of patients.Method:Pubmed database was searched using keywords “MINOCA”, “mortality” and “MACE” from 2015 to 2024. All the relevant observational studies were included using PRISMA guidelines. MACE include in-hospital mortality, heart failure, recurrent myocardial infarction (MI) and stroke.Results:7 relevant observational studies (N= 579,754) were included in the systematic review. A total of 33,050 patients had MINOCA out of which 5862 (18%) suffered MACE. 4 relevant studies were further assessed to check the specific risk of recurrent MI and stroke in MINOCA population. Out of 30,491 MINOCA patients 1095 (3.6%) had recurrent MI and 742 (2.4%) suffered from stroke. The pooled analysis revealed a statistically significant association between MACE and MINOCA patients (Odds ratio [OR] = 1.44, 95% CI: 1.03 – 2.02, p = 0.03). Further sub-analysis also revealed a statistically significant association between recurrent MI (Odds ratio [OR] = 2.05, 95% CI: 1.15 – 3.68, p = 0.02) and MINOCA. Pooled sub-analysis for association between stroke and MINOCA population was also statistically significant. (Odds ratio [OR] = 0.87, 95% CI: 0.81 – 0.94, p = 0.00)Conclusion:Although MINOCA patients experience fewer MACE as compared to OCD patients, they require a specific standardized medical management to address their pathophysiology and its associated substantial cardiovascular risk. Further research is required to prove these results and to elucidate optimal therapies to improve outcome of patients with MINOCA.

Circulation, Volume 150, Issue Suppl_1, Page A4133654-A4133654, November 12, 2024. Introduction:Conventional cardiovascular disease (CVD) risk scores are inaccurate for prostate cancer patients (PC); the Guha-Stabellini machine learning (GS-ML) score shows promise but lacks external validation.Hypothesis:The GS-ML score is superior to conventional CVD scores in patients with PC.Aim(s):To conduct external validation of the GS-ML score in patients diagnosed with PC.Methods:The validation used holdout data from Seidman Cancer Center’s CAISIS platform (internal validation cohort) and RADICAL PC1 (external validation cohort; a prospective study of men diagnosed with PC within 1 year or starting ADT within 1 month of enrollment), matching covariates with the GS-ML score. With limited follow-up, short-term CVD (2,000 days from PC diagnosis) was the outcome. Performance was assessed via area under the receiver operating characteristic curve (AUC) with assistance from Youden statistic cutoff, comparing metrics with ACC/AHA pooled cohort equations (PCE), SCORE-2, and AHA-PREVENT scores. Atherosclerotic cardiovascular disease (ASCVD) included non-fatal ischemic stroke and myocardial infarction. CVD included ASCVD and heart failure.Results:We included 2,495 patients from RADICAL PC1 and 1,506 from the internal validation cohort (Table 1). In the internal validation cohort, the CVD AUCs were 0.58, 0.49, 0.65, 0,73, and 0.75 for PCE, SCORE2, PREVENT simple, PREVENT enhanced, and GS-ML score, respectively. In RADICAL PC1, the AUCs for CVD were 0.60, 0.43, 0.67, and 0.64 for PCE, SCORE2, PREVENT simple and GS-ML score, respectively. For ASCVD, internal validation cohorts’ AUCs were 0.63, 0.62, 0.66, 0.73, and 0.67 for PCE, SCORE2, PREVENT simple, PREVENT enhanced, and Guha-Stabellini, respectively. The RADICAL PC1 ASCVD AUCs were 0.64, 0.46, 0.65, and 0.61, for PCE, SCORE2, PREVENT simple and GS-ML scores, respectively,Conclusion(s):The GS-ML score was validated for PC patients, showing superior performance to PCE and SCORE2, and similar performance to AHA-PREVENT in predicting CVD. The European Cardio-Oncology guidelines should reconsider using SCORE2 for PC patients. Further improvement and validation with nationally representative datasets are needed to corroborate these findings and enhance the generalizability of the GS-ML score.

Circulation, Volume 150, Issue Suppl_1, Page A4143931-A4143931, November 12, 2024. Background:According to the 2020 ACC/AHA guidelines, patients with severe aortic stenosis (AS) should either undergo rapid AVR or be followed by an echocardiogram (echo) every 6-12 months to assess disease progression. Discrepancies have been reported in the care of severe AS.Goal:This study aims to evaluate adherence to guidelines, and identify factors associated with guidelines recommended care in patients with severe AS.Methods:All patients with a first echo report of severe AS diagnosis from January 2019 to December 2022 in a tertiary care academic health center were included. Adherence to guidelines was defined as undergoing AVR in 6 months or having a follow-up echo within 6-12 months of the index echo. Univariable and multivariable Cox proportional hazards models were performed to identify factors associated with guidelines recommended care. Patients who did not meet the endpoint and died before one year were censored at the time of death.Results:Of the 1655 patients included in the study (mean ± SD age: 77±12 years, 56% male, 80% white, 10% African-American, and 10% other race), 727 (43%) had AVR in 6 months, 184 (11%) had no AVR in 6 months but a follow-up echo within 6-12 months, and 744 (45%) did not achieve the guidelines recommended care. Two hundred and thirty-eight (14%) patients died within one year (178 patients did not meet guidelines). The multivariable Cox proportional hazards model (Table) revealed that younger age, lower LVEF, higher aortic valve mean gradient, cardiovascular history or risk factors, and having a cardiac specialty provider increased the rate of adherence to guidelines, while African-Americans and patients with renal failure were less likely to receive the guidelines recommended care.Conclusions:A substantial proportion of patients with severe AS does not receive the guidelines recommended care and follow-up. Factors including age, race, comorbidities such as renal failure, cardiovascular history and risk factors, provider specialty, and characteristics of the AS are associated with these discrepancies. These results call for urgent action to guide patient and provider behavior towards equitably implementing guideline-recommended valvular heart disease therapies.

Circulation, Volume 150, Issue Suppl_1, Page A4144037-A4144037, November 12, 2024. Background:One-third of patients undergoing peripheral vascular intervention (PVI) for refractory claudication undergo a reintervention within 1 year. It is unknown whether receiving follow up imaging after PVI for claudication is associated with 1-year reintervention risk.Aim:To assess the association between receiving imaging follow-up within 3 months after PVI for claudication and 1-year reintervention risk before occurrence of major amputation.Method:We studied patients with claudication undergoing PVI who were alive and without reintervention at 3 months (2015-2018) in the Vascular Quality registry. Reintervention and imaging data were defined from Medicare data. Imaging follow-up included ankle brachial index (ABI), duplex ultrasound (DU), computed tomography angiography (CTA), and magnetic resonance angiogram (MRA) within 3 months post-PVI. We propensity-matched 1:1 for imaging follow-up status (No vs. Yes). The Aalen-Johansen method and Fine-Gray model assessed the 1-year cumulative incidence and reintervention risk (sub-hazard ratio, sHR) in patients without vs. with imaging follow-up, accounting for the competing mortality risk. Sensitivity analysis excluded ABI from imaging follow-up.Results:Each imaging follow-up status included 2,208 patients. Mean age was 71.3±8.4 years and 39.0% female. In patients with imaging, 47.1% received 1 imaging test, of which 75.1% were ABIs. Over 50% received ≥2 imaging tests within 3 months post-PVI, with 5% receiving ≥1 per month. The 1-year cumulative incidence and reintervention risk was similar in patients without vs. with imaging (17.5% 95%CI 15.9-19.2 vs. 18.8% 95%CI 17.1-19.2 and sHR 0.92 95%CI 0.80-1.06,P=0.259). When excluding ABI, the 1-year cumulative incidence and reintervention risk was lower in those without vs. with imaging (18.3% 95%CI 16.6-20.2 vs. 21.1% 95%CI 19.2-23.0 and sHR 0.86 95%CI 0.74-0.99,P=0.039) (Figure).Conclusion:Although over half of patients received multiple imaging tests within 3 months post-PVI for claudication, extensive imaging beyond ABI follow-up, was not associated with reintervention risk, which remained high with 1-year rates around 20%. Future efforts should study optimal imaging strategies and cost-benefit ratios.

Circulation, Volume 150, Issue Suppl_1, Page A4140642-A4140642, November 12, 2024. Background:The diagnosis of VVS largely relies on clinical history and simple diagnostic tools (e.g., electrocardiogram) to rule out dangerous differential diagnoses. However, using the head-up tilt test (HUTT) has become controversial among clinicians. This retrospective study aims to evaluate whether the prodromal symptoms experienced during HUTT are consistent with those experienced during spontaneous syncope.Methods:This study utilized data from the HUTT registry at the Syncope Unit of the tertiary Heart Center, focusing on adults aged 18 and older diagnosed with VVS. Diagnoses were based on clinical histories, physical examinations, and the latest syncope guidelines. Out of 1914 patients with HUTT results, 764 patients with positive tests were analyzed for mutual prodromal symptoms during HUTT and spontaneous syncope.Results:The McNemar test revealed significant differences for several symptoms, including palpitation (X2 = 30.59, P < 0.001), nausea (X2 = 16.13, P < 0.001), chest pain (X2 = 24.32, P < 0.001), abdominal discomfort (X2 = 22.33, P < 0.001), flushing (X2 = 10.87, P < 0.001), and aura (X2 = 19.86, P < 0.001), indicating discrepancies in the occurrence of these symptoms. Cohen's Kappa values ranged from 0.06 to 0.32, signifying slight to fair agreement. Specifically, diaphoresis (k = 0.32), palpitation (k = 0.27), and vertigo (k = 0.25) demonstrated fair agreement, whereas nausea, aura, chest pain, abdominal discomfort, and flushing exhibited slight agreement. Among the 640 patients who experienced prodrome during spontaneous syncope, 110 (17.19%) had no symptoms. Conversely, among the 123 patients who did not experience prodrome, 96 (78.05%) experienced at least one symptom during the tilt test (Figure).Conclusion:The assessment of prodromal symptoms during HUTT compared to spontaneous syncope showed significant differences for several symptoms and overall low levels of agreement. Also, tilt cannot differentiate patients with or without prodrome during their spontaneous spells.

Circulation, Volume 150, Issue Suppl_1, Page A4146105-A4146105, November 12, 2024. Introduction:International guidelines recommend cardiogenetic screening of relatives to sudden cardiac death (SCD) patients suspected of having an inherited cardiac disease. However, little is known about the long-term diagnostic yield and risk of cardiac events among relatives. This information is crucial for designing appropriate follow-up strategies for relatives.Aims:To determine the 10-year diagnostic yield and frequency of clinical outcomes in referred families to patients with all cause-SCD.Methods:In this retrospective single-center study, we included consecutively referred families to patients with all cause-SCD from 1 January 2005 until 1 October 2018. Upon referral, the cause of death in the SCD proband was assessed through autopsy reports, genetic testing, and premortem medical records. First-degree relatives were screened following a standard protocol, and diagnostic yields were assessed after five and 10 years of follow-up. Furthermore, cardiac events (i.e. death due to cardiac cause, SCD, aborted SCD, sustained ventricular tachycardia, appropriate implantable cardioverter defibrillator therapy) and relevant clinical outcomes in relatives were monitored.Results:A total of 686 relatives (304 families) were included, and mean age at follow-up was 45 years (47% males). The relatives were followed for a mean of 10.9 years during which 22 patients were lost to follow up. Screening over five years led to 73 relatives (49 families) being diagnosed, resulting in a diagnostic yield of 11%. After 10-years of follow-up, 82 relatives (56 families) were diagnosed, increasing the overall diagnostic yield to 12% with arrhythmogenic right ventricular cardiomyopathy being the most prevalent diagnosis. A total of 11 relatives experienced a cardiac event during follow-up, of whom 10 had a definite diagnosis.Conclusion:Over 10 years of follow-up, 82 (12%) relatives to patients with all cause-SCD were diagnosed with an inherited cardiac disease, primarily within the first five years. The majority of relatives who experienced a cardiac event during follow-up had a definite diagnosis. This underscores the importance of early detection and management of inherited cardiac diseases in the screening of SCD relatives.

Circulation, Volume 150, Issue Suppl_1, Page A4144360-A4144360, November 12, 2024. Background:Transthyretin cardiac amyloidosis (ATTR-CA) typically manifests with heart failure (HF). Discontinuing beta-blockers and avoiding angiotensin converting enzyme inhibitors/angiotensin receptor blockers (ACEi/ARB) in patients with ATTR-CA has been recommended.Methods:We investigated the prescription of neurohormonal therapies and their relationship with all-cause mortality in a multicenter cohort.Results:Patients (n=926) had a median age of 79 years (interquartile range 74-83), 90% were men, 17% had a left ventricular ejection fraction (LVEF) ≤40%, and 27% were in New York Heart Association (NYHA) class III/IV. At diagnosis, 60% of patients were on beta-blockers, 58% on ACEi/ARB/ARNI, and 35% on MRA. Patients on beta-blockers had more often NYHA class III/IV, a greater burden of comorbidities, and lower LVEF, and those on ACEi/ARB/ARNI had more comorbidities. Nonetheless, the survival of patients on beta-blockers or ACEi/ARB/ARNI was not significantly shorter over a 2.5-year follow-up (1.6-3.8) (p=0.577 and p=0.977, respectively), and patients on both drugs had not a worse outcome than those not receiving any neurohormonal drug (p=0.575). During the entire follow-up, the number of neurohormonal drugs remained unchanged in 54%, decreased in 27%, and increased in 19%. Patients with a number of neurohormonal drugs either unchanged or increased had a lower risk of mortality (odds ratio 0.71, 95% confidence interval 0.53-0.95, p=0.023).Conclusions:ATTRwt-CA patients on beta-blockers or ACEi/ARB/ARNI at diagnosis did not have a shorter survival. Beta-blockers were discontinued less often than ACEi/ARB/ARNI. There was no sign of better outcomes in patients discontinuing these therapies, or worse outcomes in those starting them.

Circulation, Volume 150, Issue Suppl_1, Page A4143001-A4143001, November 12, 2024. Current guidelines for treating acute decompensated heart failure (ADHF) recommend inpatient intravenous diuresis until congestion relief, as well as the initiation and advancement of guideline-directed medical therapy (GDMT). Our institution has developed a rapid diuresis team (RDT) to expedite decongestion in hospitalized ADHF patients with the goal of safely reducing length of stay. This study examines the RDT’s potential impact on GDMT titration as well as outpatient follow up timing.Does the RDT protocol improve GDMT titration and time to outpatient follow-up after discharge in patients with ADHF?This retrospective single-center study includes patients undergoing inpatient treatment for ADHF from March 2022 to November 2023 at a tertiary referral center. Demographic, clinical, and laboratory data were obtained. Standard parametric and non-parametric analyses were conducted, along with Kaplan-Meier curve analysis, with statistical significance set at p

Circulation, Volume 150, Issue Suppl_1, Page A4140494-A4140494, November 12, 2024. Background:Primary care after pregnancy is recommended, especially for individuals with recent adverse pregnancy outcomes (APOs, such as preeclampsia or gestational diabetes), who are at increased risk for future heart disease. Health-related social needs (HRSNs) are recognized barriers to care, yet their pregnancy-related prevalence and associations with care are unknown. We sought to (1) describe the pregnancy-related prevalence of HRSNs, and (2) assess associations between pregnancy-related HRSNs and subsequent linkage to primary care.Methods:We analyzed electronic health record data for individuals with prenatal care and delivery (2018-2021) at our urban safety-net hospital. HRSNs were assessed via a routine screener, and we summarized individual responses during pregnancy through 6 weeks post partum as: any positive, all negative, or never screened. Postpartum linkage to primary care was defined as a completed primary care visit after 6 weeks through 1 year post partum. We analyzed the prevalence of HRSNs and their associations with linkage to primary care, using adjusted log-linked binomial regression models. In stratified models we assessed for effect modification by APO history and other variables.Results:Of 4941 individuals in our sample, 53% identified as Black non-Hispanic and 21% as Hispanic, 68% were publicly insured, and 93% completed ≥1 HRSN screening. Nearly 1 in 4 screened positive for any HRSN, most often food insecurity (14%) or housing instability (12%), and 53% linked to primary care. Compared with those who screened negative for all HRSNs (n=3491), linkage to primary care was similar among those who screened positive for any HRSNs (n=1079; adjusted risk ratio, aRR 1.04, 95% confidence interval, CI: 0.98-1.10) and lower among those never screened (n=371; aRR 0.77, 95% CI: 0.68-0.86). We found no evidence of effect modification by APO history, race/ethnicity, insurance, language, or Covid-19 pandemic exposure.Conclusions:In this diverse postpartum sample, we identified a 24% prevalence of pregnancy-related HRSNs and 53% subsequent linkage to primary care. Linkage to primary care was not associated with HRSN screening result (positive versus negative) but was significantly negatively associated with being missed by HRSN screening. Further research is needed to better understand HRSN screening practices and who is missed by screening, and to identify modifiable barriers to postpartum primary care especially after APOs.

Circulation, Volume 150, Issue Suppl_1, Page A4120246-A4120246, November 12, 2024. Introduction:Transthoracic (TTE) guidelines after PFO device closure are vague.Goal:To perform a literature search to characterize the type, frequency, and timing of complications that occur after PFO device placement to determine the utility of routine TTE in post-device patients.Methods:A search was performed in Medline (PubMed) with English language and publication date (2000-2023) filters applied. Studies were included if they reported on PFO device closures. If a study included both PFO and ASD device closures with no distinction between the groups, it was included. Studies were excluded if it only reported on ASD device closures, were meta-analysis/review papers, or did not report any outcomes for the PFO device procedure.Results:Total of 305 articles met criteria. Incidence of complications was 6.9% (3358/48348). Maximum range of follow-up was 0 – 17 years. Types and timing of complications presented in Tables 1 and 2. Majority of complications occurred 5 years post-device. All patients with complications > 5 years device placement presented with clinical symptoms related to their complications.Conclusion:Incidence of complications after PFO device placement appeared to significantly decrease 5 years post-procedure. Late complications were all preceded by clinical symptoms. Routine use of TTE < 5 years post-device may be reasonable, but > 5 years, TTE may only be needed if clinical symptoms occur.

Pazienti, pronti a dare contributo per nuova sanità territoriale

Introduction
Buprenorphine is a highly effective treatment for opioid use disorder (OUD). However, provider observations and preliminary research suggest that the current standard maintenance dose may be insufficient for suppressing withdrawal and preventing cravings among people who use or have used fentanyl. Buprenorphine dosing guidelines were based on studies among people who use heroin and have not been formally re-evaluated since fentanyl became predominant in the unregulated drug supply. We aim to compare the effectiveness of a high (24 mg) vs standard (16 mg) maintenance daily dose of buprenorphine for improving retention in treatment, decreasing the use of non-prescribed opioids, preventing cravings and reducing opioid overdose risk in patients.

Methods and analysis
Adults who are initiating or continuing buprenorphine for moderate to severe OUD and have a recent history of fentanyl use (n=250) will be recruited at four outpatient substance use treatment clinics in Rhode Island. Patients continuing buprenorphine must be on doses of 16 mg or less and have ongoing fentanyl use to be eligible. Participants will be randomly assigned 1:1 to receive either a high (24 mg) or standard (16 mg) maintenance daily dose, each with usual care, and followed for 12 months to evaluate outcomes. Providers will determine the buprenorphine initiation strategy, with the requirement that participants reach the study maintenance dose within 7 days of randomisation. Providers may adjust the maintenance dose, if clinically needed, for participant safety. The primary study outcome is retention in buprenorphine treatment at 6 months postrandomisation, measured using clinical and statewide administrative data. Other outcomes include non-prescribed opioid use and opioid cravings (secondary), as well as non-fatal or fatal opioid overdose (exploratory).

Ethics and dissemination
This protocol was approved by the Brown Institutional Review Board (STUDY00000075). Results will be presented at conferences and published in peer-reviewed journals.

Trial registration number
NCT06316830.