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Assessment of Omecamtiv Mecarbil for the Treatment of Patients With Severe Heart Failure: A Post Hoc Analysis of Data From the GALACTIC-HF Randomized Clinical Trial.
Felker, GM, Solomon, SD, Claggett, B, Diaz, R, McMurray, JJV, Metra, M, Anand, I, Crespo-Leiro, MG, Dahlström, U, Goncalvesova, E, et al
JAMA cardiology. 2022;(1):26-34
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Abstract
IMPORTANCE Heart failure with reduced ejection fraction is a progressive clinical syndrome, and many patients' condition worsen over time despite treatment. Patients with more severe disease are often intolerant of available medical therapies. OBJECTIVE To evaluate the efficacy and safety of omecamtiv mecarbil for the treatment of patients with severe heart failure (HF) enrolled in the Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure (GALACTIC-HF) randomized clinical trial. DESIGN, SETTING, AND PARTICIPANTS The GALACTIC-HF study was a global double-blind, placebo-controlled phase 3 randomized clinical trial that was conducted at multiple centers between January 2017 and August 2020. A total of 8232 patients with symptomatic HF (defined as New York Heart Association symptom class II-IV) and left ventricular ejection fraction of 35% or less were randomized to receive omecamtiv mecarbil or placebo and followed up for a median of 21.8 months (range, 15.4-28.6 months). The current post hoc analysis evaluated the efficacy and safety of omecamtiv mecarbil therapy among patients classified as having severe HF compared with patients without severe HF. Severe HF was defined as the presence of all of the following criteria: New York Heart Association symptom class III to IV, left ventricular ejection fraction of 30% or less, and hospitalization for HF within the previous 6 months. INTERVENTIONS Participants were randomized at a 1:1 ratio to receive either omecamtiv mecarbil or placebo. MAIN OUTCOMES AND MEASURES The primary end point was time to first HF event or cardiovascular (CV) death. Secondary end points included time to CV death and safety and tolerability. RESULTS Among 8232 patients enrolled in the GALACTIC-HF clinical trial, 2258 patients (27.4%; mean [SD] age, 64.5 [11.6] years; 1781 men [78.9%]) met the specified criteria for severe HF. Of those, 1106 patients were randomized to the omecamtiv mecarbil group and 1152 to the placebo group. Patients with severe HF who received omecamtiv mecarbil experienced a significant treatment benefit for the primary end point (hazard ratio [HR], 0.80; 95% CI, 0.71-0.90), whereas patients without severe HF had no significant treatment benefit (HR, 0.99; 95% CI, 0.91-1.08; P = .005 for interaction). For CV death, the results were similar (HR for patients with vs without severe HF: 0.88 [95% CI, 0.75-1.03] vs 1.10 [95% CI, 0.97-1.25]; P = .03 for interaction). Omecamtiv mecarbil therapy was well tolerated in patients with severe HF, with no significant changes in blood pressure, kidney function, or potassium level compared with placebo. CONCLUSIONS AND RELEVANCE In this post hoc analysis of data from the GALACTIC-HF clinical trial, omecamtiv mecarbil therapy may have provided a clinically meaningful reduction in the composite end point of time to first HF event or CV death among patients with severe HF. These data support a potential role of omecamtiv mecarbil therapy among patients for whom current treatment options are limited. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02929329.
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Low-dose fentanyl does not alter muscle sympathetic nerve activity, blood pressure, or tolerance during progressive central hypovolemia.
Huang, M, Watso, JC, Belval, LN, Cimino, FA, Fischer, M, Jarrard, CP, Hendrix, JM, Laborde, CH, Crandall, CG
American journal of physiology. Regulatory, integrative and comparative physiology. 2022;(1):R55-R63
Abstract
Hemorrhage is a leading cause of battlefield and civilian trauma deaths. Several pain medications, including fentanyl, are recommended for use in the prehospital (i.e., field setting) for a hemorrhaging solider. However, it is unknown whether fentanyl impairs arterial blood pressure (BP) regulation, which would compromise hemorrhagic tolerance. Thus, the purpose of this study was to test the hypothesis that an analgesic dose of fentanyl impairs hemorrhagic tolerance in conscious humans. Twenty-eight volunteers (13 females) participated in this double-blinded, randomized, placebo-controlled trial. We conducted a presyncopal limited progressive lower body negative pressure test (LBNP; a validated model to simulate hemorrhage) following intravenous administration of fentanyl (75 µg) or placebo (saline). We quantified tolerance as a cumulative stress index (mmHg·min), which was compared between trials using a paired, two-tailed t test. We also compared muscle sympathetic nerve activity (MSNA; microneurography) and beat-to-beat BP (photoplethysmography) during the LBNP test using a mixed effects model [time (LBNP stage) × trial]. LBNP tolerance was not different between trials (fentanyl: 647 ± 386 vs. placebo: 676 ± 295 mmHg·min, P = 0.61, Cohen's d = 0.08). Increases in MSNA burst frequency (time: P < 0.01, trial: P = 0.29, interaction: P = 0.94) and reductions in mean BP (time: P < 0.01, trial: P = 0.50, interaction: P = 0.16) during LBNP were not different between trials. These data, the first to be obtained in conscious humans, demonstrate that administration of an analgesic dose of fentanyl does not alter MSNA or BP during profound central hypovolemia, nor does it impair tolerance to this simulated hemorrhagic insult.
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A Comparative Study of Health Efficacy Indicators in Subjects with T2DM Applying Power Cycling to 12 Weeks of Low-Volume High-Intensity Interval Training and Moderate-Intensity Continuous Training.
Li, J, Cheng, W, Ma, H
Journal of diabetes research. 2022;:9273830
Abstract
This study is aimed at comparing the effects of different exercise intensities, namely, high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT), on body composition, heart and lung fitness, and blood glucose, and blood pressure indices in patients with type 2 diabetes mellitus (T2DM), using power cycling. A total of 96 T2DM volunteers who met the inclusion criteria were recruited from a hospital in Yangpu, Shanghai. Based on the blood index data of their medical examination results which comprised blood pressure, fasting blood glucose, hemoglobin A1c (HbA1c), and insulin, 37 volunteers were included in the study. Exercise prescription was determined based on T2DM exercise guidelines combined with medical diagnosis and exercise test results, and the patients were randomly assigned to three groups: HIIT group, MICT group, and control (CON) group. HIIT involved one-minute power cycling (80%-95% maximal oxygen uptake (VO2max)), one-minute passive or active rest (25%-30% VO2max), and two-minute rounds of eight groups. MICT required the use of a power bike for 30 minutes of continuous training (50%-70% VO2max) five times a week. The CON group was introduced to relevant medicine, exercise, and nutrition knowledge. The exercise interventions were completed under the supervision of an exercise instructor and hospital doctors. The same indicators were measured after 12 weeks of intervention, and the results of the two tests within and between groups were analyzed for comparison. The weight index of the MICT intervention showed statistically significant within-group differences (difference = 3.52, 95% CI = 2.11-4.92, p = 0.001 < 0.01); group differences for the MICT and CON groups were also statistically significant (difference = 3.52 ± 2.09, Cd1 = -0.39 ± 1.25, p = 0.004 < 0.01). Body mass index (BMI) analysis revealed that the overall means of BMI indicators were not statistically different between groups (F = 0.369, p = 0.694 > 0.05) and the before and after values of the MICT and CON (difference = -1.30 ± 0.79, Cd1 = -0.18 ± 0.45, p = 0.001 < 0.01). No statistically significant difference was observed in the overall mean VO2max index between the groups after the 12-week intervention (F = 2.51, p = 0.100 > 0.05). A statistically significant difference was found in the overall means of the data between the two groups (difference = 0.32, 95% CI = 0.23-0.40, p = 0.001 < 0.01). Analysis of fasting blood glucose (FBG) indicators revealed statistically significant differences between the MICT and control groups (p = 0.028 < 0.05). Analysis of HbA1c and fasting insulin (FI) indicators revealed no statistically significant difference in the overall HbA1c index after the 12-week exercise intervention (F = 0.523, p = 0.598 > 0.05), and the overall difference before and after the experiment between the groups was statistically significant (F = 6.13, p = 0.006 < 0.01). No statistically significant difference was found in the FI index overall after the 12-week exercise intervention (F = 2.50, p = 0.1 > 0.05). Analysis of systolic blood pressure (SBP) revealed statistically significant difference before and after the HIIT and CON interventions (Hd7 = -1.10 ± 1.79, Cd7 = 1.2 ± 1.31, p = 0.018 < 0.05) and statistically significant difference before and after the MICT and CON interventions (Md7 = -0.99 ± 0.91, Cd7 = 1.40 ± 1.78, p = 0.02 < 0.05). The diastolic blood pressure (DBP) revealed no statistically significant within-group differences before and after. Exercise interventions applying both low-volume HIIT and MICT, with both intensity exercises designed for power cycling, improved health-related indicators in the participants; low-volume HIIT had more time advantage. The current experiment compared HIIT with MICT in a safe manner: 50% of the exercise time produced similar benefits and advantages in the two indicators of VO2max and FI. However, MICT was superior to HIIT in the two indicators of body weight (weight) and BMI. The effect of power cycling on FI has the advantages of both aerobic and resistance exercise, which may optimize the type, intensity, and time of exercise prescription according to the individual or the type of exercise program. Our results provide a reference for the personalization of exercise prescription for patients with T2DM.
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Potential influencing factors of aortic diameter at specific segments in population with cardiovascular risk.
Chen, T, Yang, X, Fang, X, Tang, L, Zhang, Y, Weng, Y, Zhang, H, Wu, J, Mao, P, Xu, B, et al
BMC cardiovascular disorders. 2022;(1):32
Abstract
BACKGROUND Aortic diameter is a critical parameter for the diagnosis of aortic dilated diseases. Aortic dilation has some common risk factors with cardiovascular diseases. This study aimed to investigate potential influence of traditional cardiovascular risk factors and the measures of subclinical atherosclerosis on aortic diameter of specific segments among adults. METHODS Four hundred and eight patients with cardiovascular risk factors were prospectively recruited in the observational study. Comprehensive transthoracic M-mode, 2-dimensional Doppler echocardiographic studies were performed using commercial and clinical diagnostic ultrasonography techniques. The aortic dimensions were assessed at different levels: (1) the annulus, (2) the mid-point of the sinuses of Valsalva, (3) the sinotubular junction, (4) the ascending aorta at the level of its largest diameter, (5) the transverse arch (including proximal arch, mid arch, distal arch), (6) the descending aorta posterior to the left atrium, and (7) the abdominal aorta just distal to the origin of the renal arteries. Multivariable linear regression analysis was used for evaluating aortic diameter-related risk factors, including common cardiovascular risk factors, co-morbidities, subclinical atherosclerosis, lipid profile, and hematological parameters. RESULTS Significant univariate relations were found between aortic diameter of different levels and most traditional cardiovascular risk factors. Carotid intima-media thickness was significantly correlated with diameter of descending and abdominal aorta. Multivariate linear regression showed potential effects of age, sex, body surface area and some other cardiovascular risk factors on aortic diameter enlargement. Among them, high-density lipoprotein cholesterol had a significantly positive effect on the diameter of ascending and abdominal aorta. Diastolic blood pressure was observed for the positive associations with diameters of five thoracic aortic segments, while systolic blood pressure was only independently related to mid arch diameter. CONCLUSION Aortic segmental diameters were associated with diastolic blood pressure, high-density lipoprotein cholesterol, atherosclerosis diseases and other traditional cardiovascular risk factors, and some determinants still need to be clarified for a better understanding of aortic dilation diseases.
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Hypertensive Retinopathy and the Risk of Stroke Among Hypertensive Adults in China.
Chen, X, Liu, L, Liu, M, Huang, X, Meng, Y, She, H, Zhao, L, Zhang, J, Zhang, Y, Gu, X, et al
Investigative ophthalmology & visual science. 2021;(9):28
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PURPOSE This study aimed to investigate the association between hypertensive retinopathy and the risk of first stroke, examine possible effect modifiers in hypertensive patients, and test the appropriateness of the Keith-Wagener-Barker (KWB) classification for predicting stroke risk. METHODS In total, 9793 hypertensive participants (3727 males and 6066 females) without stroke history from the China Stroke Primary Prevention Trial were included in this study. The primary outcome was first stroke. RESULTS Over a median follow-up of 4.4 years, 592 participants experienced their first stroke (509 ischemic, 77 hemorrhagic, and six unclassifiable strokes). In total, 5590 participants were diagnosed with grade 1 retinopathy (57.08%), 1466 with grade 2 retinopathy (14.97%), 231 with grade 3 retinopathy (2.36%), and three with grade 4 retinopathy (0.03%). Grades 1 and 2 were merged and classified as mild retinopathy, and grades 3 and 4 were merged and classified as severe retinopathy. There was a significant positive association between hypertensive retinopathy and the risk of first stroke and first ischemic stroke, and no effect modifiers were found. The hazard ratios (HRs) for first stroke were as follows: mild versus no retinopathy, 1.26 (95% confidence interval [CI], 1.01-1.58, P = 0.040), and severe versus no retinopathy, 2.40 (95% CI, 1.49-3.84, P < 0.001). The HRs for ischemic stroke were as follows: severe versus no retinopathy, 2.35 (95% CI, 1.41-3.90, P = 0.001), and nonsignificantly increased HRs for mild versus no retinopathy, 1.26 (95% CI, 0.99-1.60, P = 0.057). CONCLUSIONS There was a significant positive association between hypertensive retinopathy and the risk of first stroke in patients with hypertension, indicating that hypertensive retinopathy may be a predictor of the risk of stroke. A simplified two-grade classification system based on the KWB classification is recommended for predicting stroke risk.
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A Randomized, Double-Blind, Placebo-Controlled Trial to Determine the Effectiveness of a Polyphenolic Extract (Hibiscus sabdariffa and Lippia citriodora) for Reducing Blood Pressure in Prehypertensive and Type 1 Hypertensive Subjects.
Marhuenda, J, Pérez-Piñero, S, Arcusa, R, Victoria-Montesinos, D, Cánovas, F, Sánchez-Macarro, M, García-Muñoz, AM, Querol-Calderón, M, López-Román, FJ
Molecules (Basel, Switzerland). 2021;(6)
Abstract
Hypertension is an important factor of cardiovascular diseases and contributes to their negative consequences including mortality. The World Health Organization estimated that 54% of strokes and 47% of cases of ischemic heart illness are related to high blood pressure. Recently, Hibiscus sabdariffa (HS) and Lippia citriodora (LC) have attracted scientific interest, and they are recognized for their high content of polyphenols as these may prevent several disease factors, such as hypertension. The aim of the present study is to determine if supplementation with an HS-LC blend (MetabolAid®) may be effective for the treatment of type 1 hypertensive sedentary populations. A total of 80 type 1 hypertensive subjects of both sexes were included in the study and were treated with placebo or the HS-LC extract, and both groups were treated over 84 days. The blood pressure (diastolic, systolic, and pulse pressure) was measured throughout the day, for each of the days of the study duration and determined using Ambulatory Blood Pressure Monitoring (ABPM). Physical activity was determined throughout the study to ensure similar conditions related to exercise. The results showed the capacity for reducing the blood pressure parameters in the case of the HS-LC extract. The daily consumption of the HS-LC extract but not the placebo over 84 days was able to reduce the daytime parameters related to blood pressure. The most remarkable results were observed in the measurements performed during the daytime, especially in the systolic blood pressure showing statistically significant variation.
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Tai Ji Quan as antihypertensive lifestyle therapy: A systematic review and meta-analysis.
Wu, Y, Johnson, BT, Chen, S, Chen, Y, Livingston, J, Pescatello, LS
Journal of sport and health science. 2021;(2):211-221
Abstract
BACKGROUND Professional health organizations are not currently recommending Tai Ji Quan alongside aerobic exercise to treat hypertension. We aimed to examine the efficacy of Tai Ji Quan as antihypertensive lifestyle therapy. METHODS Tai Ji Quan interventions published in English and Chinese were included when they involved healthy adults, reported pre- and post-intervention blood pressure (BP), and had a non-exercise/non-diet control group. We systematically searched 11 electronic databases for studies published through July 31, 2018, yielding 31 qualifying controlled trials. We (1) evaluated the risk of bias and methodological study quality, (2) performed meta-regression analyses following random-effects assumptions, and (3) generated additive models representing the largest possible clinically relevant BP reductions. RESULTS Participants (n = 3223) were middle-aged (56.6 ± 15.1 years of age, mean ± SD) adults with prehypertension (systolic BP (SBP) = 136.9 ± 15.2 mmHg, diastolic BP (DBP) = 83.4 ± 8.7 mmHg). Tai Ji Quan was practiced 4.0 ± 1.4 sessions/week for 54.0 ± 10.6 min/session for 22.3 ± 20.2 weeks. Overall, Tai Ji Quan elicited significant reductions in SBP (-11.3 mmHg, 95%CI: -14.6 to -8.0; d+ = -0.75) and DBP (-4.8 mmHg, 95%CI: -6.4 to -3.1; d+ = -0.53) vs. control (p < 0.001). Controlling for publication bias among samples with hypertension, Tai Ji Quan trials published in English elicited SBP reductions of 10.4 mmHg and DBP reductions of 4.0 mmHg, which was half the magnitude of trials published in Chinese (SBP reductions of 18.6 mmHg and DBP reductions of 8.8 mmHg). CONCLUSION Our results indicate that Tai Ji Quan is a viable antihypertensive lifestyle therapy that produces clinically meaningful BP reductions (i.e., 10.4 mmHg and 4.0 mmHg of SBP and DBP reductions, respectively) among individuals with hypertension. Such magnitude of BP reductions can lower the incidence of cardiovascular disease by up to 40%.
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Short-Term RCT of Increased Dietary Potassium from Potato or Potassium Gluconate: Effect on Blood Pressure, Microcirculation, and Potassium and Sodium Retention in Pre-Hypertensive-to-Hypertensive Adults.
Stone, MS, Martin, BR, Weaver, CM
Nutrients. 2021;(5)
Abstract
Increased potassium intake has been linked to improvements in cardiovascular and other health outcomes. We assessed increasing potassium intake through food or supplements as part of a controlled diet on blood pressure (BP), microcirculation (endothelial function), and potassium and sodium retention in thirty pre-hypertensive-to-hypertensive men and women. Participants were randomly assigned to a sequence of four 17 day dietary potassium treatments: a basal diet (control) of 60 mmol/d and three phases of 85 mmol/d added as potatoes, French fries, or a potassium gluconate supplement. Blood pressure was measured by manual auscultation, cutaneous microvascular and endothelial function by thermal hyperemia, utilizing laser Doppler flowmetry, and mineral retention by metabolic balance. There were no significant differences among treatments for end-of-treatment BP, change in BP over time, or endothelial function using a mixed-model ANOVA. However, there was a greater change in systolic blood pressure (SBP) over time by feeding baked/boiled potatoes compared with control (-6.0 mmHg vs. -2.6 mmHg; p = 0.011) using contrast analysis. Potassium retention was highest with supplements. Individuals with a higher cardiometabolic risk may benefit by increasing potassium intake. This trial was registered at ClinicalTrials.gov as NCT02697708.
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Effect of Dietary Nori (Dried Laver) on Blood Pressure in Young Japanese Children: An Intervention Study.
Wada, K, Tsuji, M, Nakamura, K, Oba, S, Nishizawa, S, Yamamoto, K, Watanabe, K, Ando, K, Nagata, C
Journal of epidemiology. 2021;(1):37-42
Abstract
BACKGROUND Few studies have examined the association between seaweed intake and blood pressure in children. We conducted an intervention study to investigate whether seaweed intake affects blood pressure. METHODS Subjects were children aged 4 to 5 years attending a preschool in Aichi Prefecture, Japan, in 2010. Among 99 students, 89 (89.9%) were enrolled in our study. Nori (dried laver), an edible seaweed widely consumed in Japan, was used as a dietary intervention. Children in the intervention group were asked to consume 1.76 grams per day of roasted nori in addition to standard meals for 10 weeks. Children in the control group consumed their usual diet. Before the intervention and at the 10th week of the intervention, children's blood pressure was measured three times successively using an automated sphygmomanometer with subjects in a sitting position. Changes in systolic (SBP) and diastolic blood pressure (DBP) were compared between 55 children in the intervention group and 26 in the control group after adjustment for SBP and DBP before the intervention. RESULTS Changes in SBP were -8.29 mm Hg in the intervention group and +0.50 mm Hg in the control group (P for difference in change = 0.051). Changes in DBP were -6.77 mm Hg in the intervention group and -0.05 mm Hg in the control group (P = 0.031). In girls, no difference in blood pressure changes was found between the intervention and control groups. CONCLUSION Nori intake lowered DBP level in boys. Seaweed intake might have preventive effects on elevated blood pressure in childhood.
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ATP2B1 gene polymorphisms rs2681472 and rs17249754 are associated with susceptibility to hypertension and blood pressure levels: A systematic review and meta-analysis.
Xie, M, Yuan, S, Zeng, Y, Zheng, C, Yang, Y, Dong, Y, He, Q
Medicine. 2021;(15):e25530
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Abstract
OBJECTIVE The present study aimed to conduct a systematic review and meta-analysis to evaluate the relationships between ATP2B1 gene polymorphisms with blood pressure (BP) level and susceptibility to hypertension. METHODS PubMed, Web of Science, Embase and China National Knowledge Infrastructure (CNKI) Databases were systematically searched by 2 independent researchers to screen studies on ATP2B1 gene polymorphisms and BP related phenotypes. The records retrieval period was limited from the formation of the database to March 4, 2021. Pooled odds rations (ORs) or β and their 95% confidence intervals (95%CI) were calculated to assess the association between ATP2B1 gene polymorphisms and the risk of hypertension or BP levels. Publication bias and sensitivity analysis were conducted to find potential bias. All the statistical analysis were conducted with Stata version 11.0 software. RESULTS A total of 15 articles were ultimately included in the present study, including 15 polymorphisms of ATP2B1 gene. Nine articles (N = 65,362) reported the polymorphism rs17249754, and 7 articles(N = 91,997) reported rs2681472 (both loci were reported in 1 article). Meta-analysis showed that rs17249754 (G/A) and rs2681472 (A/G) were associated with the susceptibility to hypertension (rs17249754: OR = 1.19, 95%CI: 1.10-1.28; rs2681472: OR = 1.15, 95%CI: 1.12-1.17), and were positively associated with systolic BP (SBP) and diastolic blood pressure (DBP) (rs17249754: SBP, β=1.01, 95%CI: 0.86-1.16, DBP, β=0.48, 95%CI: 0.30-0.66; rs2681472: SBP, β=0.92, 95%CI: 0.77-1.07, DBP, β=0.50, 95%CI: 0.42-0.58) in the additive genetic model. Subgroup analysis stratified by race, population, sample size, and BP measurement method revealed that the association between A allele in rs2681472 polymorphism and risk of hypertension was slightly stronger in European (EUR) populations (OR = 1.16, 95%CI: 1.13-1.20) than in East Asians (OR = 1.14, 95%CI: 1.10-1.17). While in East Asians, relation between rs17249754 with risk of hypertension (OR = 1.19, 95%CI: 1.10-1.28) is stronger than rs2681472 (OR = 1.14, 95%CI: 1.10-1.17). CONCLUSIONS Our study demonstrated that ATP2B1 gene polymorphism rs2681472 and rs17249754 were associated with BP levels and the susceptibility to hypertension.