Research Appraisals
Evidence-based critical appraisals of the latest medical research, systematically evaluated using Oxford CEBM methodology.
Showing 9 appraisals
Sleep & breathing = Schlaf & Atmung
Which nocturnal hypoxemia parameters are associated with ambulatory blood pressure monitoring in adults with obstructive sleep apnea? A systematic review.
OBJECTIVE: Systemic arterial hypertension affects up to 50% of patients with obstructive sleep apnea (OSA) and represents one of the main modifiable cardiovascular risk factors. Hypoxemia is a recognized marker of OSA severity; however, it remains unclear which specific desaturation parameters during sleep, such as oxygen desaturation index (ODI), mean and minimum oxygen saturation (SpO2), percentage of sleep time with peripheral oxygen saturation < 90% (T90%) or hypoxic burden (HB) are most consistently associated with elevated blood pressure (BP). This systematic review aims to evaluate, in patients with OSA, the impact between nocturnal desaturation parameters and elevated BP as measured by ambulatory blood pressure monitoring (ABPM). METHODS: A literature search was performed in PubMed, Web of Science, Scopus and Embase databases, covering all records available up to June 2025. RESULTS: A total of 5,587 records were identified through database searches, and 24 studies met the inclusion criteria. The studies revealed heterogeneous results, with some showing significant associations between hypoxemia indices and hypertension, while others did not. Evidence suggests that ODI3% is commonly related to increased BP, whereas minimum SpO2, mean SpO2 and T90% yielded variable findings. HB was evaluated in only one study, suggesting a potential role in BP reduction after CPAP; however, the available evidence remains preliminary. CONCLUSION: ODI3% showed the most consistent association with increased BP across studies, whereas other hypoxemia indices yielded more variable results. Evidence regarding HB remains preliminary and warrants further investigation. These findings suggest that although ODI currently appears to be the most reliable marker, evidence from a single study indicates that composite indices such as HB may represent more informative predictors of BP outcomes and deserve further investigation in future studies.
5 July 2026
Read appraisal →European journal of preventive cardiology
Targeting better hypertension control with the usage of the ESH smartphone application
AIMS: Uncontrolled blood pressure is a main issue in the management of hypertensive patients, while mobile health (mHealth) offers a new perspective. This study aimed to investigate the efficacy of an mHealth app-based intervention, the European Society of Hypertension (ESH) CARE, in the management of uncontrolled hypertensive patients. METHODS AND RESULTS: This was a two-arm randomized, controlled trial conducted among 107 hypertensive patients, with uncontrolled office (≥140/90 mmHg) and 24-h ambulatory blood pressure (≥130/80 mmHg). After antihypertensive drug treatment initiation or intensification, patients were 1:1 randomized to application assisted strategy (AAS) group or usual care group, with scheduled visits at 1 and 3 months. In ASS group there was a virtual visit, while in usual care group there was an office visit. At 6 months, there was a final visit assessment with office and ambulatory blood pressure (BP) measurement. The mean age of the total population (n = 107) was 52.9 ± 9.6 years, 50.5% were women, without any significant differences in the baseline characteristics. At 6 months, 50% in the usual care group and 78.2% in the AAS group (P = 0.002) achieved both systolic and diastolic ambulatory BP targets (<130/80 mmHg). Regarding office BP, there was a reduction of 19.9 ± 9.1/12.4 ± 7.7 mmHg in the usual care group and 25.1 ± 6.4/16.3 ± 6.3 mmHg in the AAS group, while regarding ambulatory BP, there was a reduction of 6.6 ± 9.2/3.3 ± 6.2 mmHg and 10.9 ± 9.1/6.4 ± 5.5 mmHg, respectively. CONCLUSION: Follow-up of hypertensive patients with the ESH Care App is feasible and contributes to a significantly better office and out-of-office BP control after 6 months. Uncontrolled blood pressure is a main issue in the management of hypertensive patients, while mobile health (mHealth) offers a new perspective. This study aimed to compare the efficacy of an mHealth app-based—ESH Care App—intervention to usual clinical care, in the management of uncontrolled hypertensive patients. Telemonitoring with the ESH Care App is associated with: Significantly improvement in office and ambulatory blood pressure control. Significantly greater reduction in office and ambulatory BP measurements.
18 May 2026
Read appraisal →European journal of preventive cardiology
Cuffless Blood Pressure Monitoring Devices: Technical Foundations and Clinical Implications
Cuffless blood pressure (BP) monitoring devices represent a promising innovation in hypertension management. This scientific statement provides a comprehensive update on these emerging technologies, their specific validation requirements, their potential clinical applications, and their present and future challenges. These devices generate considerable interest by enabling non-invasive BP measurement without arterial occlusion, thereby eliminating the discomfort associated with traditional cuff-based monitoring, particularly during sleep. The technologies on which these devices are based comprise a heterogeneous group, primarily utilizing pulse wave propagation time or waveform analysis through contact or non-contact sensors. They can be categorized as continuous or intermittent, automated or manual, calibration-free or requiring cuff/demographic calibration, and wearable or stationary. This technological diversity necessitates validation protocols distinct from those used for conventional cuff-based monitors, with specific requirements for each device category. Potential clinical applications include widespread out-of-office BP monitoring, unbiased assessment of circadian BP patterns and BP variability, improved detection of nocturnal hypertension, enhanced treatment adherence and long-term BP control, and continuous monitoring in hospital settings. Additionally, their lower cost compared with conventional technologies could enhance the early detection of hypertension in resource-limited settings. However, due to insufficient accuracy validation, this scientific statement does not recommend their use in clinical decisions in spite of their potential interest, in line with international guidelines not recommending their use in hypertension management. Key challenges ahead include developing standardized validation protocols, establishing normative BP data, managing the resulting burden on clinicians in handling huge volumes of data, exploring additional haemodynamic parameters, and advancing sensor technology, mathematical models, and algorithms.
16 May 2026
Read appraisal →European journal of preventive cardiology
Visit-to-visit blood pressure variability and cardiovascular outcomes: a systematic review and dose-response meta-analysis
AIMS: Visit-to-visit blood pressure variability (VVV BPV) is a recognized risk factor for cardiovascular disease (CVD) that is underutilized in clinical practice. The reliability of electronic health record (EHR) data in estimating BPV and predicting CVD remains uncertain. This study compared BPV estimation methodologies using EHR vs. non-EHR data and examined dose-response associations with CVD. METHODS AND RESULTS: A systematic review and meta-analysis was conducted across five databases (MEDLINE, Scopus, EMBASE, CINAHL, and Web of Science) for studies published from January 2012 to August 2024. Studies assessing VVV BPV in adults and its association with CVD outcomes (e.g. myocardial infarction, stroke, heart failure, and cardiovascular mortality) were included. A dose-response meta-analysis (DRMA) evaluated BPV thresholds linked to increased CVD risk using standard deviation (SD) and coefficient of variation (CV). A total of 4926 studies were screened, 49 of which met the inclusion criteria. No consensus has emerged on BPV estimation methodologies, although non-EHR studies have followed stricter protocols. The meta-analysis showed that VVV BPV predicted any CVD outcome. Effect sizes were comparable between EHR [the hazard ratio (HR): 1.17, 95% confidence interval (CI): 1.09-1.24] and non-EHR (HR: 1.14, 95% CI: 1.10-1.17) studies (P-value = 0.468). A BPV threshold of SD 6.72 mmHg or CV 9.05% was linked to a 10% higher CVD risk. CONCLUSION: The EHR data reliably estimate BPV, yielding effect sizes similar to those of non-EHR sources. A non-linear dose-response relationship suggests that a higher BPV increases CVD risk. Visit-to-visit blood pressure variability needs to be incorporated into clinical practice, and further research is required to identify strategies to implement and scale up into routine workflow. Visit-to-visit blood pressure variability (VVV BPV) is capable of predicting CVD development in 6 years. However, its clinical use remains limited, and the reliability of electronic health records (EHR) in measuring BPV is uncertain. Having a standard deviation of VVV BPV ≥6.72 mmHg or a coefficient of variation of VVV BPV ≥9.05% mmHg is linked to a 10% higher CVD risk. Blood pressure variability estimates from EHR data were comparable to those from non-EHR studies, suggesting that EHR-based BPV assessment is reliable for CVD risk evaluation.
16 May 2026
Read appraisal →The British journal of general practice : the journal of the Royal College of General Practitioners
A systematic review of blood pressure monitor validation studies
BACKGROUND: Good hypertension care requires accurate blood pressure (BP) measurement with BP monitors validated as accurate. The British and Irish Hypertension Society maintains a peer-reviewed list of validated monitors, independent of commercial interests. The list informs National Institute for Health and Care Excellence hypertension guidance and NHS monitor procurement. An updated universal standard protocol for BP device validation was introduced in 2018. AIM: Review the literature to establish which validation protocols are now being used; has this changed since publication of the universal protocol, and what proportion of recently published BP monitor validations fully meet protocol validation criteria? METHOD: Systematic review searches of Medline and Embase from 2018 to September 2025 identified BP monitor validation studies. Citations and full texts were screened independently by two authors. Included studies were reviewed independently by two authors against checklists of protocol criteria. Disagreements were resolved through discussion and/or arbitration by lead authors. RESULTS: Seven reviewers screened 1780 unique citations, reviewing 216 full texts to date. Nine reviewers have double-extracted data from 157 publications reporting 197 device validation studies. Overall, 104 (63%) used universal protocols. While 184 (93%) validations were reported as successful by authors, only 146 (74%) fulfilled all protocol criteria on review. Thus, we considered 51 (26%) published successful validations inadequate, due to non-fulfilment of key validation criteria and/or violations of BP measurement protocols such as incomplete BP range coverage. CONCLUSION: This review highlights inadequacies in current journal peer-review processes, justifying our approach to provide impartial guidance for health professionals, purchasers, and the public.
16 May 2026
Read appraisal →Journal of the American College of Cardiology
Natriuretic Peptide Receptor-1 Agonist for Resistant Hypertension: A Randomized Phase 2 Trial
BACKGROUND: XXB750 is a potent and long-acting human monoclonal antibody agonist of the natriuretic peptide receptor-1 (NPR-1), the receptor for atrial natriuretic peptide and B-type natriuretic peptide. Activation of NPR-1 may lower blood pressure (BP) in patients with resistant hypertension through increases in the second messenger cyclic guanosine monophosphate. OBJECTIVES: The aim of this study was to determine the effect of NPR-1 agonism on 24-hour BP. METHODS: This phase 2, multicenter, randomized, double-blind, placebo-controlled trial evaluated 4 once-monthly subcutaneous doses of XXB750 (30 mg, 60 mg, 120 mg, and 240 mg) administered at baseline, week 4, and week 8 in patients with resistant hypertension. Resistant hypertension was defined as 24-hour systolic BP (SBP) ≥135 mm Hg despite treatment with 3 or 4 guideline-directed antihypertensive agents. The primary endpoint was the dose-response relationship of XXB750 vs placebo in reducing the mean 24-hour SBP from baseline to week 12. RESULTS: The study population (N = 189) had a mean age of 61 years, was 69% male, 61% White, 20% Asian, and 14% Black/African American, and had a baseline mean 24-hour ambulatory BP of 148/81 ± 11/10 mm Hg. Plasma concentrations of XXB750 dose-dependently increased in the XXB750 groups, and XXB750 dose-dependently increased plasma and urine cyclic guanosine monophosphate concentrations by week 12. However, paradoxically, there was no significant dose-dependent change from baseline in mean 24-hour SBP at week 12. In fact, none of the doses of XXB750 had a greater BP-lowering effect than placebo. Changes in ambulatory BP were not affected by the development of anti-drug antibodies. Although there were no changes from baseline in urinary sodium excretion, there were small increases in plasma renin levels in the XXB750 groups. Adverse events with XXB750 were numerically higher than with placebo. Adherence to background antihypertensive medications, assessed by drug assays in 88 patients with available plasma samples, was consistent across all treatment groups at both baseline and week 12. CONCLUSIONS: XXB750, an NPR-1 agonist, had a neutral effect on 24-hour ambulatory SBP in patients with resistant hypertension, despite showing a robust dose-response relationship for engagement of the target of pharmacologic action as indicated by increases in cyclic guanosine monophosphate levels. (An Efficacy, Safety, Tolerability and Dose Finding Study of XXB750 in Resistant Hypertension Patients; NCT05562934).
14 May 2026
Read appraisal →Journal of the American College of Cardiology
Efficacy of Tonlamarsen in Patients With Uncontrolled Hypertension: The KARDINAL Phase 2 Randomized Clinical Trial
BACKGROUND: Angiotensinogen production represents the rate-limiting step in activation of the renin-angiotensin-aldosterone system. Tonlamarsen is an investigational antisense oligonucleotide directed against hepatic angiotensinogen synthesis; its efficacy and safety among patients with hypertension are unknown. OBJECTIVES: The aim of this study was to assess the safety and efficacy of 90 mg tonlamarsen administered subcutaneously once monthly for 5 months compared with a single dose of tonlamarsen and subsequent placebo. METHODS: This randomized, placebo-controlled trial enrolled adults with office systolic blood pressure (BP) >135 mm Hg receiving 2 to 5 antihypertensive medications. Participants entered a 3-part treatment period with monthly administration of the study drug, consisting of a 4-week placebo lead-in, followed by 4-week active run-in with a single dose of tonlamarsen and subsequent randomization to 4 additional doses of tonlamarsen or matching placebo for 16 weeks. The coprimary endpoints were the between-group differences in the change from baseline to week 20 in plasma angiotensinogen and in office systolic BP. RESULTS: A total of 279 participants received placebo lead-in, 206 received 90 mg tonlamarsen during the active run-in, and 198 were randomized. The mean BP among randomized participants before and after the placebo lead-in was 147/90 and 147/89 mm Hg, respectively. Following active run-in with tonlamarsen, the mean BP was 140/87 mm Hg. Twenty weeks following the first dose of tonlamarsen, least squares (LS) mean percentage changes in plasma angiotensinogen levels were -23.0% (95% CI: -27.8% to -18.2%) with a single dose of tonlamarsen and subsequent placebo and -67.2% (95% CI: -71.9% to -62.4%) with monthly tonlamarsen administration, with a LS mean difference of -44.1% (97.5% CI: -51.9% to -36.4%; P < 0.0001). The LS mean changes in office systolic BP were -6.7 mm Hg (95% CI: -9.8 to -3.5 mm Hg) for participants following a single dose of tonlamarsen and subsequent placebo and -6.7 mm Hg (95% CI: -9.8 to -3.6 mm Hg) for participants treated with monthly tonlamarsen, with a LS mean difference of -0.1 mm Hg (95% CI: -4.5 to -4.4 mm Hg; P = 0.97). Serious adverse events were infrequent and similar between treatment groups. CONCLUSIONS: Among individuals with uncontrolled hypertension, monthly tonlamarsen administration was more effective at lowering plasma angiotensinogen compared with a single tonlamarsen dose, but there was no additional BP reduction. (A Study to Investigate Tonlamarsen for the Treatment of Adults With Uncontrolled Hypertension [KARDINAL]; NCT06864104).
14 May 2026
Read appraisal →Open heart
Effect of a mobile health intervention optimised with artificial intelligence on blood pressure and other cardiovascular risk factors in adults with high blood pressure: rationale and design of My Intelligent Cardiac Assistant (MICArdiac) randomised controlled trial
INTRODUCTION: Control of blood pressure (BP) continues to be a challenge globally. Clinical trials have shown home BP monitoring and text-message interventions to lower BP. Integrating these to personalise supportive messaging in response to changing BP and activity through leveraging artificial intelligence (AI) could improve BP control. The aim of this trial is to examine the impact on BP, compared with a text-message only programme, of the My Intelligent Cardiac Assistant (MICArdiac) programme. MICArdiac is a 6-month programme comprising tracking of BP, physical activity and heart rate informing a content stream of AI-driven personalised messages to encourage BP self-management, as-necessary medical review to up-titrate medicines and cardiovascular preventative behavioural change. METHODS AND ANALYSIS: MICArdiac is a prospective randomised open-blinded endpoint randomised controlled trial with 1:1 (intervention:control) allocation and active control. Individuals aged 35 years old or above with high BP are randomised to the MICArdiac programme or to a text-message cardiovascular education programme. Recruitment started in primary care and hospital clinics in Western Sydney and moved to decentralised direct-to-community recruitment in the Australian Capital Territory, New South Wales and Victoria. Randomisation and allocation concealment occur via a secure web-based system. The primary outcome is mean daytime systolic BP measured by 24-hour Ambulatory Blood Pressure Monitoring at 6 months. Primary analysis will follow intention-to-treat principles; data analysts will be blinded. Process evaluation will be conducted. ETHICS AND DISSEMINATION: Ethics approval was obtained from Western Sydney Local Health District Human Ethics Research Committee (2021/ETH11379). TRIAL REGISTRATION NUMBER: ACTRN12622000091707.
11 Apr 2026
Read appraisal →Physiological measurement
Continuous blood pressure monitoring via hemodynamic parameter and pulse transit time derived from capacitive sensing pads
Objective.Continuous blood pressure (BP) monitoring is crucial for detecting nocturnal hypertension and acute hemodynamic changes. Conventional cuff-based methods disrupt sleep and miss transient BP fluctuations from sleep-related events or instability. Cuffless methods, such as pulse transit time (PTT), offer potential but often struggle to reliably track acute BP fluctuations due to complex and nonlinear hemodynamics.Approach.We developed a capacitive sensing pad system incorporating PTT with additional hemodynamic features for unobtrusive, continuous BP monitoring in supine subjects. The pad contains ultra-sensitive single-electrode capacitive (SEC) sensors made from carbon nanotube composites. In passive contact, SEC sensor on the back of the chest captures intrathoracic blood volume changes through deep tissue permittivity and ballistocardiography, while another under the leg detects arterial pulse-induced tissue vibrations. PTT is derived from the temporal delay between chest and leg signals. A neural network model incorporates PTT and intrathoracic blood volume features to improve BP estimation.Main results.In human trials (N= 30) with arm-cuff reference, the system showed strong correlation (r⩾ 0.94), with a mean error (ME) ⩽ 0.1 mmHg and standard deviation (SD) ⩽ 5.6 mmHg. In a subset (N= 8) with continuous finger-cuff reference, it maintained strong correlation (r⩾ 0.89), with a ME ⩽ 0.2 mmHg and SD ⩽ 7.8 mmHg.Significance.These results suggest the possibility of bed-based unobtrusive and continuous BP monitoring in the supine position.
9 Apr 2026
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