Preliminary Experiment on the Effect of 18% Substitute Salt on Home Blood Pressure Variability in Hypertensives

At present, the effect of substitute salt in reducing sodium intake and blood pressure is relatively clear. The present study is a phase I clinical trial involving 43 hypertensives in which the effect of 18% sodium substitute salt on the home blood pressure variability (BPV) was observed for 8 weeks with weekly follow-up. Finally, 4 patients were lost, and 39 patients completed the intervention and were included in the analysis. Daily home blood pressure and weekly adverse events were collected. The systolic blood pressure (SBP) in the morning (−10.0 mmHg, 95% CI: −16.5 to −3.5, P = 0.003), SBP at night (−10.2 mmHg, 95% CI: −16.1 to −4.3, P = 0.001), and diastolic blood pressure (DBP) at night (−4.0 mmHg, 95% CI: −7.1 to −0.8, P = 0.014) decreased significantly. Also, there was no statistically significant change in morning (F = 1.137, P = 0.352) and night diastolic (F = 0.344, P = 0.481) BPV and morning systolic BPV (F = 0.663, P = 0.930) over time during the intervention period, except for that night systolic BPV had a downward trend (F = 2.778, P = 0.016) and had decreased 2.04 mmHg (95% CI: 0.84 to 3.23, P = 0.001) after intervention. The use of 18% of the substitute salt did not increase BPV during the intervention and even may decrease it, which indicates its control effects on blood pressure. This study is the first one to observe the effect of 18% sodium substitute salt on the home blood pressure variability, providing a basis for further experiments.

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Intravitreal autologous mesenchymal stem cell transplantation: a non-randomized phase I clinical trial in patients with retinitis pigmentosa

Stem Cell Research & Therapy ◽

10.1186/s13287-020-02122-7 ◽

2021 ◽

Vol 12 (1) ◽

Author(s):

Aekkachai Tuekprakhon ◽

Siripakorn Sangkitporn ◽

Adisak Trinavarat ◽

Aulia Rahmi Pawestri ◽

Visit Vamvanij ◽

...

Keyword(s):

Clinical Trial ◽

Stem Cell ◽

Adverse Events ◽

Retinitis Pigmentosa ◽

Phase I ◽

Intravitreal Injection ◽

Phase I Clinical Trial ◽

Long Term Follow Up

Abstract Background Retinitis pigmentosa (RP) is a progressive inherited retinal disease with great interest for finding effective treatment modalities. Stem cell-based therapy is one of the promising candidates. We aimed to investigate the safety, feasibility, and short-term efficacy of intravitreal injection of bone marrow-derived mesenchymal stem cells (BM-MSCs) in participants with advanced stage RP. Methods This non-randomized phase I clinical trial enrolled 14 participants, categorized into three groups based on a single dose intravitreal BM-MSC injection of 1 × 106, 5 × 106, or 1 × 107 cells. We evaluated signs of inflammation and other adverse events (AEs). We also assessed the best corrected visual acuity (BCVA), visual field (VF), central subfield thickness (CST), and subjective experiences. Results During the 12-month period, we noticed several mild and transient AEs. Interestingly, we found statistically significant improvements in the BCVA compared to baseline, although they returned to the baseline at 12 months. The VF and CST were stable, indicating no remarkable disease progression. We followed 12 participants beyond the study period, ranging from 1.5 to 7 years, and observed one severe but manageable AE at year 3. Conclusion Intravitreal injection of BM-MSCs appears to be safe and potentially effective. All adverse events during the 12-month period required observation without any intervention. For the long-term follow-up, only one participant needed surgical treatment for a serious adverse event and the vision was restored. An enrollment of larger number of participants with less advanced RP and long-term follow-up is required to evaluate the safety and efficacy of this intervention. Trial registration ClinicalTrials.gov, NCT01531348. Registered on February 10, 2012

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Blood pressure variability is related to faster cognitive decline in ischemic stroke patients: PICASSO subanalysis

Scientific Reports ◽

10.1038/s41598-021-83945-z ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Yerim Kim ◽

Jae-Sung Lim ◽

Mi Sun Oh ◽

Kyung-Ho Yu ◽

Ji Sung Lee ◽

...

Keyword(s):

Blood Pressure ◽

Ischemic Stroke ◽

Cognitive Function ◽

Cognitive Decline ◽

Repeated Measures ◽

Blood Pressure Variability ◽

Cognitive Test ◽

Multiple Variables ◽

Over Time

AbstractBlood pressure variability (BPV) is associated with higher cardiovascular morbidity risks; however, its association with cognitive decline remains unclear. We investigated whether higher BPV is associated with faster declines in cognitive function in ischemic stroke (IS) patients. Cognitive function was evaluated between April 2010 and August 2015 using the Mini-mental State Examination (MMSE) and Montreal Cognitive Assessment in 1,240 Korean PICASSO participants. Patients for whom baseline and follow-up cognitive test results and at least five valid BP readings were available were included. A restricted maximum likelihood–based Mixed Model for Repeated Measures was used to compare changes in cognitive function over time. Among a total of 746 participants (64.6 ± 10.8 years; 35.9% female). Baseline mean-MMSE score was 24.9 ± 4.7. The median number of BP readings was 11. During a mean follow-up of 2.6 years, mean baseline and last follow-up MMSE scores were 25.4 ± 4.8 vs. 27.8 ± 4.4 (the lowest BPV group) and 23.9 ± 5.2 vs. 23.2 ± 5.9 (the highest BPV group). After adjusting for multiple variables, higher BPV was independently associated with faster cognitive decline over time. However, no significant intergroup difference in cognitive changes associated with mean systolic BP was observed. Further research is needed to elucidate how BPV might affect cognitive function.

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Impact of Model Choice When Studying the Relationship Between Blood Pressure Variability and Risk of Stroke Recurrence

Hypertension ◽

10.1161/hypertensionaha.120.16807 ◽

2021 ◽

Author(s):

Hugues de Courson ◽

Loïc Ferrer ◽

Antoine Barbieri ◽

Phillip J. Tully ◽

Mark Woodward ◽

...

Keyword(s):

Blood Pressure ◽

Blood Pressure Variability ◽

Proportional Hazards ◽

Cox Model ◽

Positive Association ◽

Vascular Risk Factor ◽

Stroke Recurrence ◽

The Impact ◽

Over Time

Long-term blood pressure variability (BPV), an increasingly recognized vascular risk factor, is challenging to analyze. The objective was to assess the impact of BPV modeling on its estimated effect on the risk of stroke. We used data from a secondary stroke prevention trial, PROGRESS (Perindopril Protection Against Stroke Study), which included 6105 subjects. The median number of blood pressure (BP) measurements was 12 per patient and 727 patients experienced a first stroke recurrence over a mean follow-up of 4.3 years. Hazard ratios (HRs) of BPV were estimated from 6 proportional hazards models using different BPV modeling for comparison purposes. The 3 commonly used methods first derived SD of BP measures observed over a given period of follow-up and then used it as a fixed covariate in a Cox model. The 3 more advanced modeling accounted for changes in BP or BPV over time in a single-stage analysis. While the 3 commonly used methods produced contradictory results (for a 5 mmHg increase in BPV, HR=0.75 [95% CI, 0.68–0.82], HR=0.99 [0.91–1.08], HR=1.19 [1.10–1.30]), the 3 more advanced modeling resulted in a similar moderate positive association (HR=1.08 [95% CI, 0.99–1.17]), whether adjusted for BP at randomization or mean BP over the follow-up. The method used to assess BPV strongly affects its estimated effect on the risk of stroke, and should be chosen with caution. Further methodological developments are needed to account for the dynamics of both BP and BPV over time, to clarify the specific role of BPV.

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POS0815 CLINICAL CHARACTERISTICS, IMAGING PHENOTYPE, AND LONG-TERM OUTCOMES OF TAKAYASU ARTERITIS PATIENTS WITH HYPERTENSION

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.3494 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 661.1-661

Author(s):

Y. Sun ◽

L. Ma ◽

H. Chen ◽

C. Rongyi ◽

L. Jiang

Keyword(s):

Blood Pressure ◽

Adverse Events ◽

Clinical Features ◽

Takayasu Arteritis ◽

Pressure Control ◽

Free Survival ◽

The World ◽

Cluster 2

Background:Hypertension occurred in 30-80% of TAK patients around the world. The occurrence of hypertension might severely worsen TAK prognosis. Nevertheless, data describing the specific imaging features in hypertensive TAK patients and the associations between hypertensive severity, blood pressure control status and long-term outcome were still lacking.Objectives:To investigate the characteristics and associations of hypertensive characteristics with adverse events-free survival in Takayasu arteritis (TAK) patients with hypertension.Methods:This research was based on a prospectively on-going observational cohort-East China Takayasu Arteritis (ECTA) cohort. In all, 618 TAK patients, who registered in the ECTA cohort up to December 2019, were enrolled. The main outcome was the adverse-events-free survival among hypertensive TAK patients during the follow-up ended on August 2020.Results:Totally, 204 (33.0%) patients suffered from hypertension, with 48 (23.5%), 62 (30.4%), and 94 (46.1%) mild, moderate, and severe hypertension, respectively. Cluster analysis indicated three imaging phenotypes for hypertensive TAK patients: Cluster 1: involvement of the abdominal aorta and/or renal artery (n=56, 27.5%); Cluster 2: involvement of the ascending aorta, thoracic aorta, and the aortic arch and its branches (n=38, 18.6%); Cluster 3: combined involvement of Cluster 1 and Cluster 2 (n=111, 54.4%). By the end of the follow-up, the blood pressure control rate was 50.8%, while the adverse-events-free survival was 67.9% in the entire hypertensive population. Multivariate Cox regression analysis indicated that well-controlled blood pressure (HR=2.13, 95%CI 1.32–3.78, p=0.047), co-existence of severe aortic valve regurgitation (HR=0.87, 95%CI 0.64–0.95, p=0.043), Cluster 1 (HR=0.69, 95%CI 0.48–0.92, p=0.017) and Cluster 3 (HR=0.72, 95%CI 0.43–0.94, p=0.048) imaging phenotype was associated with the adverse-events-free survival.Conclusion:Patients with controlled hypertension showed better adverse-events-free survival, while those with the Cluster 1 imaging phenotype were more likely to suffer from worse adverse-events-free survival. Hypertension occurred in 30-80% of TAK patients around the world. The occurrence of hypertension might severely worsen TAK prognosis.References:[1]Johnston SL, Lock RJ, Gompels MM. Takayasu arteritis: a review. J Clin Pathol 2002; 55:481–6.[2]Watanabe Y, Miyata T, Tanemoto K. Current clinical features of new patients with Takayasu arteritis observed from a cross-country research in Japan: age and sex specificity. Circulation 2015; 132:1701–9.[3]Yilmaz N, Can M, Oner FA, et al. Impaired quality of life, disability and mental health in Takayasu’s arteritis. Rheumatol. (Oxford) 2013; 52:1898–904.[4]Laurent A, Julien H, Nicolas L, et al. Takayasu arteritis in France: a single-center retrospective study of 82 cases comparing white, North African, and black patients. Medicine 2010; 89:1–17.[5]Mwipatayi BP, Jeffery PC, Beningfield SJ, et al. Takayasu arteritis: clinical features and management: report of 272 cases. ANZ J Surg 2005; 75:110–7.Disclosure of Interests:None declared

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Allogeneic Umbilical Cord Blood–Derived Mesenchymal Stem Cell Implantation Versus Microfracture for Large, Full-Thickness Cartilage Defects in Older Patients: A Multicenter Randomized Clinical Trial and Extended 5-Year Clinical Follow-up

Orthopaedic Journal of Sports Medicine ◽

10.1177/2325967120973052 ◽

2021 ◽

Vol 9 (1) ◽

pp. 232596712097305

Author(s):

Hong-Chul Lim ◽

Yong-Beom Park ◽

Chul-Won Ha ◽

Brian J. Cole ◽

Beom-Koo Lee ◽

...

Keyword(s):

Clinical Trial ◽

Adverse Events ◽

Cartilage Repair ◽

Older Patients ◽

Cartilage Defects ◽

Full Thickness ◽

Phase 3 ◽

Randomized Controlled ◽

Cartilage Restoration

Background: There is currently no optimal method for cartilage restoration in large, full-thickness cartilage defects in older patients. Purpose: To determine whether implantation of a composite of allogeneic umbilical cord blood–derived mesenchymal stem cells and 4% hyaluronate (UCB-MSC-HA) will result in reliable cartilage restoration in patients with large, full-thickness cartilage defects and whether any clinical improvements can be maintained up to 5 years postoperatively. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A randomized controlled phase 3 clinical trial was conducted for 48 weeks, and the participants then underwent extended 5-year observational follow-up. Enrolled were patients with large, full-thickness cartilage defects (International Cartilage Repair Society [ICRS] grade 4) in a single compartment of the knee joint, as confirmed by arthroscopy. The defect was treated either with UCB-MSC-HA implantation through mini-arthrotomy or with microfracture. The primary outcome was proportion of participants who improved by ≥1 grade on the ICRS Macroscopic Cartilage Repair Assessment (blinded evaluation) at 48-week arthroscopy. Secondary outcomes included histologic assessment; changes in pain visual analog scale (VAS) score, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and International Knee Documentation Committee (IKDC) score from baseline; and adverse events. Results: Among 114 randomized participants (mean age, 55.9 years; 67% female; body mass index, 26.2 kg/m2), 89 completed the phase 3 clinical trial and 73 were enrolled in the 5-year follow-up study. The mean defect size was 4.9 cm2 in the UCB-MSC-HA group and 4.0 cm2 in the microfracture group ( P = .051). At 48 weeks, improvement by ≥1 ICRS grade was seen in 97.7% of the UCB-MSC-HA group versus 71.7% of the microfracture group ( P = .001); the overall histologic assessment score was also superior in the UCB-MSC-HA group ( P = .036). Improvement in VAS pain, WOMAC, and IKDC scores were not significantly different between the groups at 48 weeks, however the clinical results were significantly better in the UCB-MSC-HA group at 3- to 5-year follow-up ( P < .05). There were no differences between the groups in adverse events. Conclusion: In older patients with symptomatic, large, full-thickness cartilage defects with or without osteoarthritis, UCB-MSC-HA implantation resulted in improved cartilage grade at second-look arthroscopy and provided more improvement in pain and function up to 5 years compared with microfracture. Registration: NCT01041001, NCT01626677 (ClinicalTrials.gov identifier).

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The Worsening of Positional Mild Obstructive Sleep Apnea over Time Is Associated with an Increase in Body Weight: Impact on Blood Pressure and Autonomic Nervous System

Respiration ◽

10.1159/000517031 ◽

2021 ◽

pp. 1-10

Author(s):

Wei-Hsiu Chang ◽

Hsien-Chang Wu ◽

Chou-Chin Lan ◽

Yao-Kuang Wu ◽

Mei-Chen Yang

Keyword(s):

Blood Pressure ◽

Obstructive Sleep Apnea ◽

Nervous System ◽

Autonomic Nervous System ◽

Sleep Apnea ◽

Obstructive Sleep ◽

Mild Obstructive Sleep Apnea ◽

Positional Dependency ◽

Over Time

Background: Most patients with mild obstructive sleep apnea (OSA) are positional dependent. Although mild OSA worsens over time, no study has assessed the natural course of positional mild OSA. Objectives: The aim of this study was to evaluate the natural course of positional mild OSA, its most valuable progression predictor, and its impact on blood pressure (BP) and the autonomic nervous system (ANS). Methods: This retrospective observational cohort study enrolled 86 patients with positional mild OSA and 26 patients with nonpositional mild OSA, with a follow-up duration of 32.0 ± 27.6 months and 37.6 ± 27.8 months, respectively. Polysomnographic variables, BP, and ANS functions were compared between groups at baseline and after follow-up. Results: In patients with positional mild OSA after follow-up, the apnea/hypopnea index (AHI) increased (9.1 ± 3.3/h vs. 22.0 ± 13.2/h, p = 0.000), as did the morning systolic BP (126.4 ± 13.3 mm Hg vs. 130.4 ± 15.9 mm Hg, p = 0.011), and the sympathetic activity (49.4 ± 12.3% vs. 55.3 ± 13.1%, p = 0.000), while the parasympathetic activity decreased (50.6 ± 12.3% vs. 44.7 ± 13.1%, p = 0.000). The body mass index changes were the most important factor associated with AHI changes among patients with positional mild OSA (Beta = 0.259, adjust R2 = 0.056, p = 0.016, 95% confidence interval 0.425 and 3.990). The positional dependency disappeared over time in 66.3% of patients with positional mild OSA while 69.2% of patients with nonpositional mild OSA retained nonpositional. Conclusions: In patients with positional mild OSA, disease severity, BP, and ANS regulation worse over time. Increased weight was the best predictor for its progression and the loss of positional dependency. Better treatments addressing weight control and consistent follow-up are needed for positional mild OSA.

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[PP.06.26] EFFECT OF STANDARDIZED ALGORITHMIC TREATMENT ON HOME BLOOD PRESSURE VARIABILITY

Journal of Hypertension ◽

10.1097/01.hjh.0000523356.83259.10 ◽

2017 ◽

Vol 35 ◽

pp. e136

Author(s):

K.M. Amosova ◽

I.U. Rudenko

Keyword(s):

Blood Pressure ◽

Blood Pressure Variability ◽

Home Blood Pressure ◽

Algorithmic Treatment

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Abstract P494: Long-term Outcomes of a Cluster-randomized Trial Testing the Effects Blood Pressure Telemonitoring and Pharmacist Management

Hypertension ◽

10.1161/hyp.70.suppl_1.p494 ◽

2017 ◽

Vol 70 (suppl_1) ◽

Author(s):

Karen L Margolis ◽

Stephen E Asche ◽

Anna R Bergdall ◽

Steven P Dehmer ◽

Beverly B Green ◽

...

Keyword(s):

Blood Pressure ◽

Randomized Trial ◽

Clinical Care ◽

Cluster Randomized Trial ◽

Home Blood Pressure ◽

Uncontrolled Hypertension ◽

Routine Clinical Care ◽

Differential Reduction ◽

Cluster Randomized

Background/Aims: Hypertension is a common condition and leading cause of cardiovascular disease. We previously reported results of a cluster-randomized trial evaluating a home blood pressure (BP) telemonitoring and pharmacist management intervention, with significant reductions in BP favoring the intervention arm over 18 months. This analysis examined the durability of the intervention effect on BP through 54 months of follow-up and compared BP measurements performed in the research clinic and in routine clinical care. Methods: The Hyperlink trial randomized 16 primary care clinics having 450 study-enrolled patients with uncontrolled hypertension to either Telemonitoring Intervention (TI) or usual care (UC) study arms. BP was measured as the mean of 3 measurements obtained at each research clinic visit. General linear mixed models utilizing a direct likelihood-based ignorable approach for missing data were used to examine change from baseline to 54 months in systolic and diastolic BP (SBP and DBP). Results: Research clinic BP measurements were obtained from 326 (72%) study patients at the 54 month follow-up visit. Routine clinical care BP measurements were obtained from 444 (99%) of study patients from 7025 visits during the follow-up period. For TI patients, based on research clinic measurements baseline SBP was 148.2 mm Hg and 54 month follow-up was 131.2 mm Hg (-17.0 mm Hg, p<.001). For UC patients, baseline SBP was 147.7 mm Hg and 54 month follow-up was 131.7 mm Hg ( -16.0 mm Hg, p<.001). The differential reduction by study arm in SBP from baseline to 54 months was -1.0 mm Hg (95% CI: -5.4 to 3.4, p=0.63). For TI patients, baseline DBP was 84.4 mm Hg and 54 month follow-up was 77.8 (-6.6 mm Hg, p<.001). For UC patients, baseline DBP was 85.1 mm Hg and 54 month follow-up was 79.1 mm Hg (-6.0 mm Hg, p<.001). The differential reduction by study arm in DBP from baseline to 54 months was -0.6 mm Hg (95% CI: -3.5 to 2.4, p=0.67). SBP and DBP results from routine clinical measurements closely approximated the pattern of results from research clinic measurements. Conclusion: Significant BP reductions in the TI arm relative to UC were no longer seen at 54 month follow-up. To maintain intervention benefits over a longer period of time additional intervention is needed.

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Hypertension

10.2310/im.1099 ◽

2020 ◽

Author(s):

Marc P Bonaca

Keyword(s):

Blood Pressure ◽

Ambulatory Blood Pressure Monitoring ◽

Ambulatory Blood Pressure ◽

Sodium Intake ◽

Blood Pressure Monitoring ◽

Home Blood Pressure ◽

Pressure Monitoring ◽

Blood Pressure Targets ◽

Treatment Targets ◽

Treatment Of Hypertension

Hypertension is a common chronic disorder with an increasing prevalence in the context of an aging population. Patients with hypertension are at risk for adverse cardiovascular, renal, and neurologic outcomes. Treatment of hypertension reduces this associated risk; therefore, early diagnosis and systematic management are critical in reducing morbidity and mortality. Although hypertension is multifactorial, a large component is related to lifestyle, including excess sodium intake, lack of physical activity, and obesity. Lifestyle intervention and education, therefore, are critical to both prevention and treatment of hypertension. Patients diagnosed with hypertension should be evaluated for their overall risk, with specific therapies and treatment targets guided by their characteristics and comorbidities. Several professional and guideline societies have published recommendations with regard to the diagnosis and treatment of hypertension, which have many similarities but also several areas of discussion and ongoing debate. Recent evolutions in the field include the expanded indications for home-based and ambulatory blood pressure monitoring and outcomes trials, which add important data regarding optimal treatment targets. These evolutions are likely to be addressed in ongoing guideline updates. This review contains 10 figures, 15 tables, and 67 references. Key words: ambulatory blood pressure monitoring, antihypertensive therapy, blood pressure, blood pressure targets, cardiovascular risk, high blood pressure, home blood pressure monitoring, hypertension, screening, secondary hypertension

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