Home blood pressure monitors owned by participants in a large decentralised clinical trial in hypertension: the Treatment In Morning versus Evening (TIME) study.
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ABSTRACT:
SUBMITTER: Anbarasan T
PROVIDER: S-EPMC8766290 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundMorning hypertension is a risk factor for cardiovascular and cerebrovascular events, and consequently diagnosis and control of morning hypertension are considered very important. We previously reported the results of the Azelnidipine Treatment for Hypertension Open-label Monitoring in the Early morning (At-HOME) Study, which indicated that azelnidipine effectively controlled morning hypertension.ObjectivesThe objective of this At-HOME subgroup analysis was to evaluate the sustained blood pressure (BP)-lowering effect of azelnidipine, using mean morning and evening systolic BP [ME average] and morning systolic BP minus evening systolic BP (ME difference).MethodsWe analyzed the self-measured home BP data (measured in the morning and at bedtime) from this 16-week prospective observational study to clarify the effect of morning dosing of azelnidipine (mean [± standard deviation] maximum dose 14.3 ± 3.6 mg/day). A subgroup of patients from the At-HOME Study who had an evening home BP measurement within 28 days prior to the baseline date were used for efficacy analysis (n = 2,546; mean age, 65.1 years; female, 53.6 %).ResultsHome systolic BP/diastolic BP levels in the morning and evening were significantly lowered (p < 0.0001) by -19.4 ± 17.1/-10.3 ± 10.6 and -16.9 ± 17.0/-9.4 ± 10.6 mmHg, respectively. Home pulse rates in the morning and evening were also significantly lowered (p < 0.0001) by -3.5 ± 7.8 and -3.5 ± 7.3 beats/min, respectively. At baseline, patients whose ME average was ≥135 mmHg and whose ME difference was ≥15 mmHg (defined as morning-predominant hypertension) accounted for 20.4 % of the study population. However, at the end of the study, the number of such patients was significantly reduced to 7.9 % (p < 0.0001). Patients whose ME average was ≥135 mmHg and whose ME difference was <15 mmHg (defined as sustained hypertension) accounted for 71.1 % of the study population at baseline. This was reduced significantly to 42.8 % at the end of the study (p < 0.0001). ME average decreased significantly from 153.8 ± 15.5 mmHg to 135.6 ± 11.9 mmHg, and ME difference also decreased significantly from 6.7 ± 13.1 mmHg to 4.7 ± 10.8 mmHg (both p < 0.0001).ConclusionThese results suggest that azelnidipine improved morning hypertension with its sustained BP-lowering effect.
| S-EPMC3627021 | biostudies-literature
Project description:BACKGROUND:The aging population is associated with increased multimorbidity and polypharmacy. Older adults are at a higher risk of adverse events and reduced therapeutic response. This phenomenon is partially explained by drug interactions and treatment adherence. Most randomized clinical trials have found no significant differences between morning and evening levothyroxine (LT4) administration in young adults, but there is little evidence regarding alternative LT4 regimens in older populations. Thus, the MONIALE trial aims to test an alternative schedule for LT4 administration in older adults. METHODS/DESIGN:This randomized crossover clinical trial will include participants aged 60?years or older with primary hypothyroidism. The trial groups will consist of morning LT4 intake (60?min before breakfast) or evening LT4 intake (60?min after supper). The primary outcome will be variation in serum thyrotropin (TSH) levels after 24?weeks of the LT4 protocol. The secondary outcomes will be the prevalence of drugs that potentially interact with LT4 and hypothyroidism control according to interaction status. The sample size was calculated to detect a minimum mean difference of 1 mUI/L in serum TSH level between the groups with 80% power and a 5% probability of type I error, resulting in 91 patients per group. The project was approved by the Hospital de Clínicas de Porto Alegre Ethics Committee. DISCUSSION:Considering the aging population, the increased prevalence of multimorbidity and polypharmacy, as well as potential drug interactions and treatment adherence difficulties, an alternative LT4 protocol could be useful for hypothyroidism treatment in the elderly. Prior studies comparing alternative LT4 administration protocols have mainly included young adult populations and have not addressed potential drug interactions. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03614988. Registered 30 July 2018.
| S-EPMC6918562 | biostudies-literature
Project description:Studies suggest that bedtime dosing of an angiotensin-converting enzyme (ACE)-inhibitor or angiotensin receptor blocker shows a more sustained and consistent 24-h antihypertensive profile, including greater night-time blood pressure (BP) reduction. We compared the antihypertensive effects of morning (a.m.) and evening (p.m.) dosing of valsartan on 24-h BP.This 26-week, multicentre, randomized, double-blind study evaluated the efficacy and safety of valsartan 320?mg, dosed a.m. or p.m., versus lisinopril 40?mg (a.m.), a long-acting ACE-inhibitor, in patients with grade 1-2 hypertension and at least one additional cardiovascular risk factor. Patients (n?=?1093; BP?=?156?±?11/91?±?8?mmHg; 62 years, 56% male, 99% white) received (1?:?1?:?1) valsartan 160?mg a.m. or p.m. or lisinopril 20?mg a.m. for 4 weeks, then force-titrated to double the initial dose for 8 weeks. At Week 12, hydrochlorothiazide (HCTZ) 12.5?mg was added for 14 weeks if office BP was more than 140/90?mmHg and/or ambulatory BP more than 130/80?mmHg.Mean 24-h ambulatory SBP change from baseline to Weeks 12 and 26 was comparable between valsartan a.m. (-10.6 and -13.3?mmHg) and p.m. (-9.8 and -12.3?mmHg) and lisinopril (-10.7 and -13.7?mmHg). There was no benefit of valsartan p.m. versus a.m. on night-time BP, early morning BP and morning BP surge. Evening dosing also did not improve BP lowering in patients requiring add-on HCTZ or in nondippers at baseline. All treatments were well tolerated.Once-daily dosing of valsartan 320?mg results in equally effective 24-h BP efficacy, regardless of dosing time.ClinicalTrials.gov Identifier: NCT00241124.
| S-EPMC4284009 | biostudies-literature
Project description:A great deal of evidence has been gathered on the use of creatine as an ergogenic supplement. Recent studies show greater benefits when creatine ingestion is performed close in time to training, but few studies tackle the way that circadian rhythms could influence creatine consumption. The aim of this study was therefore to observe the influence circadian rhythms exert on sports performance after creatine supplementation. Our method involved randomly assigning fourteen women players of a handball team into two groups in a single-blind study: one that consumed the supplement in the morning and one that consumed it in the evening, with both groups following a specific training program. After twelve weeks, the participants exhibited a decreased fat percentage, increased body weight and body water, and improved performance, with these results being very similar in the two groups. It is therefore concluded that, although circadian rhythms may influence performance, these appear not to affect creatine supplementation, as creatine is stored intramuscularly and is available for those moments of high energy demand, regardless of the time of day.
| S-EPMC8744932 | biostudies-literature
Project description:The authors evaluated differences in the reliability of home blood pressure measurements taken in the morning, before dinner, and at bedtime. Forty-eight patients with hypertension (age range, 50-89 years; mean age, 76.4 years) measured their home blood pressure using a validated automatic information/communication technology-based device for 14 consecutive days. Those days were divided into the first seven days (1-7) and the following 8 to 14 days (days 8-14) and compared systolic blood pressure (SBP) reliability in the two periods for each measurement time point. In Bland-Altman analyses, morning SBP showed the least standard error of measurement (3.0 mm Hg). There were fixed biases in morning and before-dinner SBP with average limits of agreement of 3.9 and 6.4 mm Hg, respectively. For at-bedtime SBP, a random error was detected and the minimal detectable change was 13.8 mm Hg. The percentage of near-maximal variation of morning SBP was the smallest at 18.1%. Morning SBP therefore provided the most reliable home blood pressure value in the day.
| S-EPMC8030996 | biostudies-literature
Project description:BackgroundHome blood pressure monitoring (HBPM) is gaining popularity among hypertensive patients. This study aimed to explore the influence of self-initiated HBPM on primary care patients with hypertension.MethodsSix in-depth interviews and two focus group discussions were conducted, taking into consideration the experiences of 24 primary care patients with hypertension. These patients had been using HBPM as part of their hypertension management. The overriding influences were grouped under themes which emerged from analyzing the data using the grounded theory approach.ResultsThere are both positive and negative influences of self-initiated HBPM. Patients used the readings of their HBPM to decide on many aspects of their hypertension management. The HBPM readings both influenced their adherence to diet and exercise and provided certain reassurance when they experienced symptoms. In addition, the act of discussing their HBPM readings with their health care providers resulted in an enhanced doctor-patient therapeutic relationship. Nevertheless, HBPM created confusion at times in some patients, particularly with regard to the target blood pressure level and the need for medication. This led to some patients making their own medical decisions based on their own standards.ConclusionsHBPM is becoming an integral part of hypertension management. Primary care patients who self-initiated HBPM reported being more self-efficacious, but lack of participation and guidance from their doctors created confusion, and hindered the true benefit of HBPM.
| S-EPMC3271963 | biostudies-literature
Project description:Substantial gains in muscle strength and hypertrophy are clearly associated with the routine performance of resistance training. What is less evident is the optimal timing of the resistance training stimulus to elicit these significant functional and structural skeletal muscle changes. Therefore, this investigation determined the impact of a single bout of resistance training performed either in the morning or evening upon acute anabolic signalling (insulin-like growth factor-binding protein-3 (IGFBP-3), myogenic index and differentiation) and catabolic processes (cortisol). Twenty-four male participants (age 21.4±1.9yrs, mass 83.7±13.7kg) with no sustained resistance training experience were allocated to a resistance exercise group (REP). Sixteen of the 24 participants were randomly selected to perform an additional non-exercising control group (CP) protocol. REP performed two bouts of resistance exercise (80% 1RM) in the morning (AM: 0800 hrs) and evening (PM: 1800 hrs), with the sessions separated by a minimum of 72 hours. Venous blood was collected immediately prior to, and 5 min after, each resistance exercise and control sessions. Serum cortisol and IGFBP-3 levels, myogenic index, myotube width, were determined at each sampling period. All data are reported as mean ± SEM, statistical significance was set at P?0.05. As expected a significant reduction in evening cortisol concentration was observed at pre (AM: 98.4±10.5, PM: 49.8±4.4 ng/ml, P<0.001) and post (AM: 98.0±9.0, PM: 52.7±6.0 ng/ml, P<0.001) exercise. Interestingly, individual cortisol differences pre vs post exercise indicate a time-of-day effect (AM difference: -2±2.6%, PM difference: 14.0±6.7%, P = 0.03). A time-of-day related elevation in serum IGFBP-3 (AM: 3274.9 ± 345.2, PM: 3605.1 ± 367.5, p = 0.032) was also evident. Pre exercise myogenic index (AM: 8.0±0.6%, PM: 16.8±1.1%) and myotube width (AM: 48.0±3.0, PM: 71.6±1.9 ?m) were significantly elevated (P<0.001) in the evening. Post exercise myogenic index was greater AM (11.5±1.6%) compared with PM (4.6±0.9%). No difference was observed in myotube width (AM: 48.5±1.5, PM: 47.8±1.8 ?m) (P>0.05). Timing of resistance training regimen in the evening appears to augment some markers of hypertrophic potential, with elevated IGFBP-3, suppressed cortisol and a superior cellular environment. Further investigation, to further elucidate the time course of peak anabolic signalling in morning vs evening training conditions, are timely.
| S-EPMC5008805 | biostudies-literature
Project description:Binge alcohol consumption elicits acute and robust increases of muscle sympathetic nerve activity (MSNA), yet the impact of evening binge drinking on morning-after MSNA is unknown. The present study examined the effects of evening binge alcohol consumption on polysomnographic sleep and morning-after MSNA. We hypothesized that evening binge drinking (i.e. 4-5 drink equivalent in <2 h) would reduce sleep quality and increase morning-after blood pressure (BP) and MSNA. Following a familiarization night within the sleep laboratory, 22 participants (12 men, 10 women; 25 ± 1 yr) were examined after simulated binge drinking or fluid control (randomized, crossover design). Morning MSNA was successfully recorded across both conditions in 16 participants (8 men, 8 women) during a 10-min baseline and three Valsalva's maneuvers (VM). Binge drinking reduced rapid eye movement (REM) sleep (15 ± 1 vs. 20 ± 1%, P = 0.003), increased stage II sleep (54 ± 1 vs. 51 ± 1%, P = 0.002), and increased total urine output (2.9 ± 0.2 vs. 2.1 ± 0.1 liters, P < 0.001) but did not alter morning-after urine specific gravity. Binge drinking increased morning-after heart rate [65 (54-72) vs. 58 (51-67) beats/min, P = 0.013] but not resting BP or MSNA. Binge drinking elicited greater sympathoexcitation during VM (38 ± 3 vs. 43 ± 3 bursts/min, P = 0.036). Binge drinking augmented heart rate (P = 0.002), systolic BP (P = 0.022), and diastolic BP (P = 0.037) reactivity to VM phase IV and blunted cardiovagal baroreflex sensitivity during VM phases II (P = 0.028) and IV (P = 0.043). In conclusion, evening binge alcohol consumption disrupted REM sleep and morning-after autonomic function. These findings provide new mechanistic insight into the potential role of binge drinking on cardiovascular risk.NEW & NOTEWORTHY Chronic binge alcohol consumption is associated with future cardiovascular disease (CVD) risk in both men and women. In addition, binge alcohol consumption is known to disrupt normal sleep quality during the early morning hours, coinciding with the morning sympathetic surge. In the present study, an evening of binge alcohol consumption increased baseline morning heart rate and cardiovascular reactivity during the Valsalva maneuver (VM) strain. Specifically, muscle sympathetic nerve activity and phase IV hemodynamic responses increased during VM the morning after binge alcohol consumption. The autonomic dysfunction and increased cardiovascular reactivity during VM suggests a contributing mechanism to CVD risk present in individuals who binge drink.
| S-EPMC7864252 | biostudies-literature
Project description:In the ANAFIE Registry home blood pressure subcohort, we evaluated 5204 patients aged ≥75 years with non-valvular atrial fibrillation (NVAF) to assess blood pressure (BP) control, prevalence of masked hypertension, and anticoagulant use. Mean clinic (C) and home (H) systolic/diastolic BP(SBP/DBP) was 128.5/71.3 and 127.7/72.6 mm Hg, respectively. Overall, 77.5% of patients had hypertension; of these, 27.7%, 13.4%, 23.4%, and 35.6% had well-controlled, white coat, masked, and sustained hypertension, respectively. Masked hypertension prevalence increased with diabetes, decreased renal function, age ≥80 years, current smoker status, and chronic obstructive pulmonary disease. By morning/evening average, 59.0% of patients had mean H-SBP ≥ 125 mm Hg; 48.9% had mean C-SBP ≥ 130 mm Hg. Early morning hypertension (morning H-SBP ≥ 125 mm Hg) was found in 65.9% of patients. Although 51.1% of patients had well-controlled C-SBP, 52.5% of these had uncontrolled morning H-SBP. In elderly NVAF patients, morning H-BP was poorly controlled, and masked uncontrolled morning hypertension remains significant.
| S-EPMC8029869 | biostudies-literature
Project description:This study investigates factors associated with active participation, and long-term commitment, to home blood pressure monitoring (HBPM) in the TIME study, a remote clinical trial assessing the effectiveness of morning vs. evening dosing of antihypertensive medications on cardiovascular outcomes in adults with hypertension. Participants reporting HBPM ownership were invited to submit blood pressure (BP) measurements three-monthly. Factors associated with active participation (submitting at least one set of BP measurements), and longer-term commitment (at least six sets of BP measurements), were analysed using multivariable logistic regression. 11,059 participants agreed to provide BP measurements, of whom 7646 submitted. Active participation was associated with age (adjusted odds ratio (AOR) per decade, 1.29; 95% CI 1.23-1.36), positive family history of hypertension (AOR 1.11; 95% CI 1.01-1.21), number of antihypertensive medications (AOR, 1.10; 95% CI 1.04-1.16), and lower deprivation (AOR per decile, 1.03; 95% CI 1.01-1.05). People with higher body mass index (BMI) and smokers were less likely to participate (AOR, 0.91 (per increase of 5.0 kg/m2) and 0.63 respectively; all p < 0.001). 3,655 participants (47.8%) submitted measurements beyond one year. Non-modifiable risk factors - age (AOR per decade, 1.29; 95% CI 1.21-1.37) and positive family history of hypertension (AOR, 1.15; 95% CI 1.03-1.27) - were positively associated with longer-term commitment. Higher BMI (AOR per 5.0 kg/m2, 0.89; 95% CI 0.85-0.93), smoking (AOR 0.60, 95% CI 0.44-0.82) and higher baseline systolic blood pressure (AOR per mmHg, 0.99; 95% CI 0.98-0.99) were negatively associated. This study provides insight into factors that influence HBPM use.
| S-EPMC8524396 | biostudies-literature