Contemporary treatment patterns of overweight and obesity: insights from the Mass General Brigham health care system.

Objective: The objective of this study was to describe the prevalence of obesity, obesity-related conditions (ORCs), and antiobesity medication (AOM) eligibility and prescribing practice among eligible patients in a large health care system.

Methods: In this cross-sectional analysis of the multicenter Mass General Brigham health care system (Boston, Massachusetts) spanning 2018 to 2022, adults eligible for AOMs (BMI ≥ 30 kg/m or BMI 27-29.9 kg/m with ≥1 ORC) were identified.

Validation of self-reported hypertension in young adults in the US-based Growing Up Today Study (GUTS).

Background: Self-reporting is often used in large epidemiologic research to identify hypertensive participants, but its validity in young adults has not been sufficiently assessed. We aimed to validate self-reported hypertension diagnosis from questionnaires by using medical records among a sample of young adults aged 22-39 years in the Growing Up Today Study (GUTS), during a time of transition in national hypertension definitions.

Methods: A sample of 1,000 GUTS participants were asked for permission to access their medical records, to confirm their self-reported hypertension status on questionnaires from 2010 to 2019.

Childhood exposure to air pollution, noise, and surrounding greenness and incident hypertension in early adulthood in a US nationwide cohort-the Growing Up Today Study (GUTS).

Exposure to increased air pollution, noise, and reduced surrounding greenness have been suggested as potential environmental risk factors for hypertension in adults, but limited evidence exists regarding early-life exposure, particularly from prospective studies. We investigated independent and joint associations of childhood exposure to these factors with incident hypertension in early adulthood in a US nationwide cohort. Study participants were from the Growing Up Today Study (GUTS) established in 1996 (GUTSI) and 2004 (GUTSII), who were ages 9-14 (GUTSI) or 10-17 (GUTSII) at enrollment.

Renal Denervation for the Treatment of Hypertension: A Scientific Statement From the American Heart Association.

Hypertension is a leading risk factor for cardiovascular morbidity and mortality. Despite the widespread availability of both pharmacological and lifestyle therapeutic options, blood pressure control rates across the globe are worsening. In fact, only 23% of individuals with high blood pressure in the United States achieve treatment goals.

Multiple Environmental Exposures and the Development of Hypertension in a Prospective US-Based Cohort of Female Nurses: A Mixture Analysis.

We investigated the independent and joint associations between multiple environmental exposures and incident hypertension in a US nationwide prospective cohort of women: the Nurses' Health Study II. We followed 107,532 nonhypertensive participants from 1989 to diagnosis of hypertension, loss to follow-up, death, or end of follow-up in June 2019. We applied Cox proportional hazards models to assess associations of incident hypertension with time-varying residential exposure to air pollution, noise, surrounding greenness, temperature, and neighborhood socioeconomic status (nSES), adjusting for potential confounders and coexposures.

Optimizing time-in-target-range assessment for blood pressure: insights from a large-scale study with continual cuffless monitoring.

Introduction: Blood pressure (BP) time-in-target-range (TTR) is an emerging predictor of cardiovascular risk. Conventional BP methods are fundamentally unable to provide an optimal assessment of TTR, using irregular measurements separated by lengthy intervals. We investigated the optimal duration and frequency for reliable, practical TTR assessment in clinical settings using continual monitoring.

Diagnosis and management of resistant hypertension.

Resistant hypertension is defined as blood pressure that remains above the therapeutic goal despite concurrent use of at least three antihypertensive agents of different classes, including a diuretic, with all agents administered at maximum or maximally tolerated doses. Resistant hypertension is also diagnosed if blood pressure control requires four or more antihypertensive drugs. Assessment requires the exclusion of apparent treatment resistant hypertension, which is most often the result of non-adherence to treatment.

Real-world experience with ultrasound renal denervation utilizing home blood pressure monitoring: the Global Paradise System registry study design.

Background: Hypertension is a major public health issue due to its association with cardiovascular disease risk. Despite the availability of effective antihypertensive drugs, rates of blood pressure (BP) control remain suboptimal. Renal denervation (RDN) has emerged as an effective non-pharmacological, device-based treatment option for patients with hypertension.

Patient-Level Pooled Analysis of Endovascular Ultrasound Renal Denervation or a Sham Procedure 6 Months After Medication Escalation: The RADIANCE Clinical Trial Program.

Background: The randomized, sham-controlled RADIANCE-HTN (A Study of the Recor Medical Paradise System in Clinical Hypertension) SOLO, RADIANCE-HTN TRIO, and RADIANCE II (A Study of the Recor Medical Paradise System in Stage II Hypertension) trials independently met their primary end point of a greater reduction in daytime ambulatory systolic blood pressure (SBP) 2 months after ultrasound renal denervation (uRDN) in patients with hypertension. To characterize the longer-term effectiveness and safety of uRDN versus sham at 6 months, after the blinded addition of antihypertensive treatments (AHTs), we pooled individual patient data across these 3 similarly designed trials.

Methods: Patients with mild to moderate hypertension who were not on AHT or with hypertension resistant to a standardized combination triple AHT were randomized to uRDN (n=293) versus sham (n=213); they were to remain off of added AHT throughout 2 months of follow-up unless specified blood pressure (BP) criteria were exceeded.

Remote Cardiovascular Hypertension Program Enhanced Blood Pressure Control During the COVID-19 Pandemic.

Background The COVID-19 pandemic disrupted traditional health care; one fallout was a drastic decrease in blood pressure (BP) assessment. We analyzed the pandemic's impact on our existing remote hypertension management program's effectiveness and adaptability. Methods and Results This retrospective observational analysis evaluated BP control in an entirely remote management program before and during the pandemic.

Innovative Remote Management Solutions for the Control of Hypertension.

We stand at a critical juncture in the delivery of health care for hypertension. Blood pressure control rates have stagnated, and traditional health care is failing. Fortunately, hypertension is exceptionally well-suited to remote management, and innovative digital solutions are proliferating.

Patient-Level Pooled Analysis of Ultrasound Renal Denervation in the Sham-Controlled RADIANCE II, RADIANCE-HTN SOLO, and RADIANCE-HTN TRIO Trials.

Importance: Ultrasound renal denervation (uRDN) was shown to lower blood pressure (BP) in patients with uncontrolled hypertension (HTN). Establishing the magnitude and consistency of the uRDN effect across the HTN spectrum is clinically important.

Objective: To characterize the effectiveness and safety of uRDN vs a sham procedure from individual patient-level pooled data across uRDN trials including either patients with mild to moderate HTN on a background of no medications or with HTN resistant to standardized triple-combination therapy.

Endovascular Ultrasound Renal Denervation to Treat Hypertension: The RADIANCE II Randomized Clinical Trial.

Importance: Two initial sham-controlled trials demonstrated that ultrasound renal denervation decreases blood pressure (BP) in patients with mild to moderate hypertension and hypertension that is resistant to treatment.

Objective: To study the efficacy and safety of ultrasound renal denervation without the confounding influence of antihypertensive medications in patients with hypertension.

Design, Setting, And Participants: Sham-controlled, randomized clinical trial with patients and outcome assessors blinded to treatment assignment that was conducted between January 14, 2019, and March 25, 2022, at 37 centers in the US and 24 centers in Europe, with randomization stratified by center.

Results of a Remotely Delivered Hypertension and Lipid Program in More Than 10 000 Patients Across a Diverse Health Care Network.

Importance: Blood pressure (BP) and cholesterol control remain challenging. Remote care can deliver more effective care outside of traditional clinician-patient settings but scaling and ensuring access to care among diverse populations remains elusive.

Objective: To implement and evaluate a remote hypertension and cholesterol management program across a diverse health care network.

Effects of Renal Denervation vs Sham in Resistant Hypertension After Medication Escalation: Prespecified Analysis at 6 Months of the RADIANCE-HTN TRIO Randomized Clinical Trial.

Importance: Although early trials of endovascular renal denervation (RDN) for patients with resistant hypertension (RHTN) reported inconsistent results, ultrasound RDN (uRDN) was found to decrease blood pressure (BP) vs sham at 2 months in patients with RHTN taking stable background medications in the Study of the ReCor Medical Paradise System in Clinical Hypertension (RADIANCE-HTN TRIO) trial.

Objectives: To report the prespecified analysis of the persistence of the BP effects and safety of uRDN vs sham at 6 months in conjunction with escalating antihypertensive medications.

Design, Setting, And Participants: This randomized, sham-controlled, clinical trial with outcome assessors and patients blinded to treatment assignment, enrolled patients from March 11, 2016, to March 13, 2020.

A remote hypertension management program clinical algorithm.

Introduction: Hypertension is the leading risk factor for death, affecting over one billion people worldwide, yet control rates are poor and stagnant. We developed a remote hypertension management program that leverages digitally transmitted home blood pressure (BP) measurements, algorithmic care pathways, and patient-navigator communications to aid patients in achieving guideline-directed BP goals.

Methods: Patients with uncontrolled hypertension are identified through provider referrals and electronic health record screening aided by population health managers within the Mass General Brigham (MGB) health system.

Guidance for the Interpretation of Continual Cuffless Blood Pressure Data for the Diagnosis and Management of Hypertension.

Hypertension remains the leading risk factor for death worldwide. Despite its prevalence, success of blood pressure (BP) management efforts remains elusive, and part of the difficulty lies in the tool still used to diagnose, measure, and treat hypertension: the sphygmomanometer introduced by Samuel Siegfried Karl von Basch in 1867. In recent years, there has been an explosion of devices attempting to provide estimates of BP without a cuff, overcoming many limitations of cuff-based BP monitors.

Clinical Trial Design Principles and Outcomes Definitions for Device-Based Therapies for Hypertension: A Consensus Document From the Hypertension Academic Research Consortium.

The clinical implications of hypertension in addition to a high prevalence of both uncontrolled blood pressure and medication nonadherence promote interest in developing device-based approaches to hypertension treatment. The expansion of device-based therapies and ongoing clinical trials underscores the need for consistency in trial design, conduct, and definitions of clinical study elements to permit trial comparability and data poolability. Standardizing methods of blood pressure assessment, effectiveness measures beyond blood pressure alone, and safety outcomes are paramount.

Plasma renin and aldosterone concentrations related to endovascular ultrasound renal denervation in the RADIANCE-HTN SOLO trial.

Objective: The RADIANCE-HTN SOLO trial demonstrated a greater reduction in daytime ambulatory SBP at 2 months by endovascular ultrasound renal denervation than sham procedure. We hypothesized that plasma renin and aldosterone concentrations would be associated with the SBP response to renal denervation.

Methods: Hypertensive patients were randomized to renal denervation (n = 74) or sham (n = 72) after a 4-week washout of antihypertensive medications.

Predictors of blood pressure response to ultrasound renal denervation in the RADIANCE-HTN SOLO study.

The blood pressure (BP) lowering response to renal denervation (RDN) remains variable with about one-third of patients not responding to ultrasound or radiofrequency RDN. Identification of predictors of the BP response to RDN is needed to optimize patient selection for this therapy. This is a post-hoc analysis of the RADIANCE-HTN SOLO study.

Euglycemic Diabetic Ketoacidosis With COVID-19 Infection in Patients With Type 2 Diabetes Taking SGLT2 Inhibitors.

Objective: Diabetes mellitus is associated with poor outcomes in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Diabetic ketoacidosis (DKA) has also been reported to occur with this virus. A cluster of cases of euglycemic DKA (euDKA) was identified in patients with type 2 diabetes mellitus using sodium-glucose cotransporter-2 inhibitors (SGLT2is) who developed SARS-CoV-2 infection.

12-Month Results From the Unblinded Phase of the RADIANCE-HTN SOLO Trial of Ultrasound Renal Denervation.

Objectives: This study reports the 12-month results of the RADIANCE-HTN (A Study of the ReCor Medical Paradise System in Clinical Hypertension) SOLO trial following unblinding of patients at 6 months.

Background: The blood pressure (BP)-lowering efficacy and safety of endovascular ultrasound renal denervation (RDN) in the absence (2 months) and presence (6 months) of antihypertensive medications were previously reported.

Methods: Patients with daytime ambulatory BP ≥135/85 mm Hg after 4 weeks off medication were randomized to RDN (n = 74) or sham (n = 72) and maintained off medication for 2 months.

Six-Month Results of Treatment-Blinded Medication Titration for Hypertension Control After Randomization to Endovascular Ultrasound Renal Denervation or a Sham Procedure in the RADIANCE-HTN SOLO Trial.

Background: The multicenter, international, randomized, blinded, sham-controlled RADIANCE-HTN SOLO trial (A Study of the ReCor Medical Paradise System in Clinical Hypertension) demonstrated a 6.3 mm Hg greater reduction in daytime ambulatory systolic blood pressure (BP) at 2 months by endovascular ultrasound renal denervation (RDN) compared with a sham procedure among patients not treated with antihypertensive medications. We report 6-month results after the addition of a recommended standardized stepped-care antihypertensive treatment to the randomized endovascular procedure under continued blinding to initial treatment.