Blood Pressure Visit Intensification Study in Treatment: Trial design.
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ABSTRACT:
SUBMITTER: Fiscella K
PROVIDER: S-EPMC4684589 | biostudies-literature | 2015 Dec
REPOSITORIES: biostudies-literature
Publications
Blood Pressure Visit Intensification Study in Treatment: Trial design.
Fiscella Kevin K Ogedegbe Gbenga G He Hua H Carroll Jennifer J Cassells Andrea A Sanders Mechelle M Khalida Chamanara C D'Orazio Brianna B Tobin Jonathan N JN
American heart journal 20150912 6
<h4>Background</h4>There is a presumption that, for patients with uncontrolled blood pressure (BP), early follow-up, that is, within 4 weeks of an elevated reading, improves BP control. However, data are lacking regarding effective interventions for increasing clinician frequency of follow-up visits and whether such interventions improve BP control.<h4>Methods/design</h4>Blood Pressure Visit Intensification Study in Treatment involves a multimodal approach to improving intensity of follow-up in ...[more]
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Project description:Studies of visit-to-visit office blood pressure (BP) variability (OBPV) as a predictor of cardiovascular events and death in high-risk patients treated to lower BP targets are lacking. We conducted a post hoc analysis of SPRINT (Systolic Blood Pressure Intervention Trial), a well-characterized cohort of participants randomized to intensive (<120 mm Hg) or standard (<140 mm Hg) systolic BP targets. We defined OBPV as the coefficient of variation of the systolic BP using measurements taken during the 3-,6-, 9-, and 12-month study visits. In our cohort of 7879 participants, older age, female sex, black race, current smoking, chronic kidney disease, and coronary disease were independent determinants of higher OBPV. Use of thiazide-type diuretics or dihydropyridine calcium channel blockers was associated with lower OBPV whereas angiotensin-converting enzyme inhibitors or angiotensin receptor blocker use was associated with higher OBPV. There was no difference in OBPV in participants randomized to standard or intensive treatment groups. We found that OBPV had no significant associations with the composite end point of fatal and nonfatal cardiovascular events (n=324 primary end points; adjusted hazard ratio, 1.20; 95% confidence interval, 0.85-1.69, highest versus lowest quintile) nor with heart failure or stroke. The highest quintile of OBPV (versus lowest) was associated with all-cause mortality (adjusted hazard ratio, 1.92; confidence interval, 1.22-3.03) although the association of OBPV overall with all-cause mortality was marginal (P=0.07). Our results suggest that clinicians should continue to focus on office BP control rather than on OBPV unless definitive benefits of reducing OBPV are shown in prospective trials. CLINICAL TRIAL REGISTRATION:URL: http://www.clinicaltrials.gov. Unique identifier: NCT01206062.
| S-EPMC6209591 | biostudies-literature
Project description:We examined blood pressure 1 year after stroke discharge and its association with treatment intensification.We examined the systolic blood pressure (SBP) stratified by discharge SBP (?140, 141-160, or >160 mm Hg) among a national cohort of Veterans discharged after acute ischemic stroke. Hypertension treatment opportunities were defined as outpatient SBP >160 mm Hg or repeated SBPs >140 mm Hg. Treatment intensification was defined as the proportion of treatment opportunities with antihypertensive changes (range, 0%-100%, where 100% indicates that each elevated SBP always resulted in medication change).Among 3153 patients with ischemic stroke, 38% had ?1 elevated outpatient SBP eligible for treatment intensification in the 1 year after stroke. Thirty percent of patients had a discharge SBP ?140 mm Hg, and an average 1.93 treatment opportunities and treatment intensification occurred in 58% of eligible visits. Forty-seven percent of patients discharged with SBP 141 to160 mm Hg had an average of 2.1 opportunities for intensification and treatment intensification occurred in 60% of visits. Sixty-three percent of the patients discharged with an SBP >160 mm Hg had an average of 2.4 intensification opportunities, and treatment intensification occurred in 65% of visits.Patients with discharge SBP >160 mm Hg had numerous opportunities to improve hypertension control. Secondary stroke prevention efforts should focus on initiation and review of antihypertensives before acute stroke discharge; management of antihypertensives and titration; and patient medication adherence counseling.
| S-EPMC4308422 | biostudies-literature
Project description:Hypertension and blood pressure variability (BPV; SD and average real variability) in primary proteinuric glomerulopathies are not well described. Data were from 433 participants in the NEPTUNE (Nephrotic Syndrome Study Network). Hypertensive BP status was defined as previous history of hypertension or BP ?140/90 mm Hg for adults/?95th percentile for children at baseline. BPV was measured in participants with ?3 visits in the first year. Two-hundred ninety-six adults (43 years [interquartile range, 32-57.8 years], 61.5% male) and 147 children (11 years [interquartile range, 5-14 years], 57.8% male) were evaluated. At baseline, 64.8% of adults and 46.9% of children were hypertensive. Histological diagnosis was associated with hypertensive status in adults (P=0.036). In adults, hypertensive status was associated with lower hazard of complete remission (hazard ratio, 0.36; 95% confidence interval, 0.19-0.68) and greater hazard of achieving the composite end point (end-stage renal disease or estimated glomerular filtration rate decline >40%; hazard ratio, 4.1; 95% confidence interval, 1.4-12). Greater systolic and diastolic SD and average real variability were also associated with greater hazard of reaching the composite end point in adults (all P<0.01). In children, greater BPV was an independent predictor of composite end point (determined by systolic SD and average real variability) and complete remission (determined by systolic and diastolic average real variability; all P<0.05). Hypertensive status was common among adults and children enrolled in NEPTUNE. Differences in hypertensive status prevalence, BPV, and treatment were found by age and histological diagnosis. In addition, hypertensive status and greater BPV were associated with poorer clinical outcomes.
| S-EPMC5518633 | biostudies-literature
Project description:Background It remains unclear whether physicians' attitudes toward timely management of elevated blood pressure affect the risk of stroke recurrence. Methods and Results From a multicenter stroke registry database, we identified 2933 patients with acute ischemic stroke who were admitted to participating centers in 2011, survived at the 1-year follow-up period, and returned to outpatient clinics ≥2 times after discharge. As a surrogate measure of physicians' attitude, individual treatment intensification (TI) scores were calculated by dividing the difference between the frequencies of observed and expected medication changes by the frequency of clinic visits and categorizing them into 5 groups. The association between TI groups and the recurrence of stroke within 1 year was analyzed using hierarchical frailty models, with adjustment for clustering within each hospital and relevant covariates. Mean±SD of the TI score was -0.13±0.28. The TI score groups were significantly associated with increased risk of recurrent stroke compared with Group 3 (TI score range, -0.25 to 0); Group 1 (range, -1 to -0.5), adjusted hazard ratio (HR) 13.43 (95% CI, 5.95-30.35); Group 2 (range, -0.5 to -0.25), adjusted HR 4.59 (95% CI, 2.01-10.46); and Group 4 (TI score 0), adjusted HR 6.60 (95% CI, 3.02-14.45); but not with Group 5 (range, 0-1), adjusted HR 1.68 (95% CI, 0.62-4.56). This elevated risk in the lowest TI score groups persisted when confining analysis to those with hypertension, history of blood pressure-lowering medication, no atrial fibrillation, and regular clinic visits and stratifying the subjects by functional capacity at discharge. Conclusions A low TI score, which implies physicians' therapeutic inertia in blood pressure management, was associated with a higher risk of recurrent stroke. The TI score may be a useful performance indicator in the outpatient clinic setting to prevent recurrent stroke.
| S-EPMC8174371 | biostudies-literature
Project description:ObjectivesTo assess how often older adults admitted to hospital for common non-cardiac conditions were discharged with intensified antihypertensive treatment, and to identify markers of appropriateness for these intensifications.DesignRetrospective cohort study.SettingUS Veterans Administration Health System.ParticipantsPatients aged 65 years or over with hypertension admitted to hospital with non-cardiac conditions between 2011 and 2013.Main outcome measuresIntensification of antihypertensive treatment, defined as receiving a new or higher dose antihypertensive agent at discharge compared with drugs used before admission. Hierarchical logistic regression analyses were used to control for characteristics of patients and hospitals.ResultsAmong 14?915 older adults (median age 76, interquartile range 69-84), 9636 (65%) had well controlled outpatient blood pressure before hospital admission. Overall, 2074 (14%) patients were discharged with intensified antihypertensive treatment, more than half of whom (1082) had well controlled blood pressure before admission. After adjustment for potential confounders, elevated inpatient blood pressure was strongly associated with being discharged on intensified antihypertensive regimens. Among patients with previously well controlled outpatient blood pressure, 8% (95% confidence interval 7% to 9%) of patients without elevated inpatient blood pressure, 24% (21% to 26%) of patients with moderately elevated inpatient blood pressure, and 40% (34% to 46%) of patients with severely elevated inpatient blood pressure were discharged with intensified antihypertensive regimens. No differences were seen in rates of intensification among patients least likely to benefit from tight blood pressure control (limited life expectancy, dementia, or metastatic malignancy), nor in those most likely to benefit (history of myocardial infarction, cerebrovascular disease, or renal disease).ConclusionsOne in seven older adults admitted to hospital for common non-cardiac conditions were discharged with intensified antihypertensive treatment. More than half of intensifications occurred in patients with previously well controlled outpatient blood pressure. More attention is needed to reduce potentially harmful overtreatment of blood pressure as older adults transition from hospital to home.
| S-EPMC6283373 | biostudies-literature
Project description:Visit-to-visit blood pressure variability (VTV-BPV) is an independent risk factor for cardiovascular events and death in the general population. We sought to determine the association of VTV-BPV with outcomes in patients on hemodialysis, using data from a National Institutes of Health-sponsored randomized trial (the HEMO study). We used the coefficient of variation (CV) and the average real variability in systolic blood pressure (SBP) as metrics of VTV-BPV. In all, 1844 out of 1846 randomized subjects had at least three visits with SBP measurements and were included in the analysis. Median follow-up was 2.5 years (interquartile range 1.3-4.3 years), during which time there were 869 deaths from any cause and 408 (adjudicated) cardiovascular deaths. The mean pre-dialysis SBP CV was 9.9 ± 4.6%. In unadjusted models, we found a 31% higher risk of death from any cause per 10% increase in VTV-BPV. This association was attenuated after multivariable adjustment but remained statistically significant. Similarly, we found a 28% higher risk of cardiovascular death per 10% increase in VTV-BPV, which was attenuated and no longer statistically significant in fully adjusted models. The associations among VTV-BPV, death and cardiovascular death were modified by baseline SBP. In a diverse, well-dialyzed cohort of patients on maintenance hemodialysis, VTV-BPV, assessed using metrics of variability in pre-dialysis SBP, was associated with a higher risk of all-cause mortality and a trend toward higher risk of cardiovascular mortality, particularly in patients with a lower baseline SBP.
| S-EPMC3795854 | biostudies-literature
Project description:BackgroundResearch of hypertension-related risk factors for Alzheimer's disease has typically focused on blood pressure (BP) levels, despite evidence that high blood pressure variability (BPV) over time may predict poorer cardiovascular, neuropathological, and neurocognitive outcomes. We evaluated associations between BPV and cognitive function in the Multi-Ethnic Study of Atherosclerosis (MESA).MethodsMultivariable linear and logistic regression analyses of BP data across six examinations were used to determine associations that BPV (average real variability [ARV], variability independent of the mean [VIM]) and group-based latent BP trajectories have with cognitive function, decline, and impairment, measured by the Cognitive Abilities Screening Instrument (CASI), Digit Symbol Coding (DSC), and Digit Span tests.ResultsParticipants (N = 1314; mean baseline age = 57) were 50% female, and 48% White. Higher systolic (β = -0.06, 95% confidence interval [CI]: -0.12, -0.0001) and diastolic (β = -0.08, 95% CI: -0.14, -0.02) ARV predicted increased global cognitive decline after covariate adjustment. Stronger relationships between BPV and global cognition were in older, White and Black participants, apolipoprotein E (APOE) ε4 non-carriers, male participants, and non-antihypertensive medication users.ConclusionResults suggest that higher systolic and diastolic BPV is an independent risk factor for cognitive dysfunction and decline in this multi-ethnic cohort. This relationship differs across demographic and clinical characteristics.
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Project description:Uncertainty persists regarding the need to address blood pressure (BP) variability in the general population to reduce the heavy burden of stroke. In this cohort study, we prospectively recruited 57,927 participants from southeast of Beijing, who have completed all 3 health examinations between 2006 and 2010. BP variability was defined as the coefficient of variation (CV) across these 3 visits. Over a median follow-up of 3.0 years, we identified 582 first stroke cases. Of these, 489 (84.0%) were ischemic strokes and 94 (16.2%) were hemorrhagic strokes. After multivariable adjustment, the hazard ratios (HR) (95% Confidence Intervals, CI) of comparing participants in the highest versus lowest quartile of CV of systolic blood pressure (SBP) was 1.44 (1.11, 1.87) for any stroke, 1.33 (1.00, 1.77) for ischemic stroke, and 2.17 (1.09, 4.35) for hemorrhagic stroke. Similar results were also observed when the CV of SBP was considered as a continuous exposure variable (per SD increase). Moreover, higher variability of diastolic blood pressure (DBP) was also significantly associated with the risk of any stroke and specifically with hemorrhagic stroke, but not with ischemic stroke. In conclusion, higher visit-to-visit BP variability might be an important target to reduce stroke risk, particularly for hemorrhagic stroke.
| S-EPMC5428298 | biostudies-literature
Project description:We aim to determine if visit-to-visit blood pressure variability (BPV) adds prognostic value for all-cause mortality independently of the Framingham risk score (FRS) in the systolic blood pressure intervention trial (SPRINT). We defined BPV as variability independent of the mean (VIM) and the difference of maximum minus minimum (MMD) of the systolic blood pressure (SBP). Multivariable Cox proportional hazards models were used to estimate the hazard ratio (HR) and 95% confidence interval (CI). Based on FRS stratification, there were 1035, 2911, and 4050 participants in the low-, intermediate-, and high-risk groups, respectively. During the trial, 230 deaths occurred since the 12th month with an average follow-up of 2.5 years. In continuous analysis, 1-SD increase of SBP VIM and MMD were significantly associated with all-cause mortality (HR 1.18, 95% CI 1.05-1.32, p = .005; and HR 1.21, 95% CI 1.09-1.35, p < .001, respectively). In category analysis, the highest quintile of BPV compared with the lowest quintile had significantly higher risk of all-cause mortality. Cross-tabulation analysis showed that the 3rd tertile of SBP VIM in the high-risk group had the highest HR of all-cause mortality in total population (HR 4.99; 95% CI 1.57-15.90; p = .007), as well as in intensive-therapy group (HR 7.48; 95% CI 1.01-55.45; p = .05) analyzed separately. Cross-tabulation analysis of SBP MMD had the same pattern as VIM showed above. In conclusion, visit-to-visit BPV was an independent predictor of all-cause mortality, when accounting for conventional risk factors or FRS. BPV combined with FRS conferred an increased risk for all-cause mortality in the SPRINT trial.
| S-EPMC8678842 | biostudies-literature
Project description:Measuring blood pressure (BP) at home and remote monitoring can improve the patient's adherence to BP control and vascular outcomes. This study evaluated the feasibility of a trial regarding the effects of an intensive mobile BP management strategy versus usual care in acute ischemic stroke patients. A feasibility-testing, randomized, open-labeled controlled trial was conducted. Remote BP measurement, data transmission, storage, and centralized monitoring system were organized through a Bluetooth-equipped sphygmomanometer paired to the participants' smartphones. Participants were randomized equally into intensive management (behavioral intensification to measure BP at home by texting, direct telephone call, or breakthrough visit) and control (usual care) groups. The primary feasibility outcomes were: 1) recruitment time for the pre-specified number of participants, 2) retention of participants, 3) frequency of breakthrough visit calls, 4) response to breakthrough visit call, and 5) proportions satisfying BP measurement criteria. Sixty participants were randomly assigned to the intensive management (n = 31) and control (n = 29) groups, of which 57 participants were included in the primary analysis with comparable baseline characteristics. Recruitment time from the first to the last participant was 350 days, and 95% of randomized participants completed the final visit (intensive, 94%; control, 98%). Eight breakthrough visit calls were made to 7 participants (23%), with complete and immediate responses within 3 ± 4 days. The median of half-day blocks fulfilling the BP measurement criteria per patient were 91% in the intensive group and 83% in the control group (difference, 12.2; 95% confidence interval, 2.2-22.2). No adverse events related to the trial procedures were reported. The intensive monitoring, including remote BP measurement, data transfer, and centralized monitoring system, engaged with behavioral intensification was feasible if the patients complied with the intervention. However, the device utilized would need further improvement prior to a large trial.
| S-EPMC7065804 | biostudies-literature