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Design of the Blood Pressure Goals in Dialysis pilot study.

ABSTRACT: Cardiovascular disease (CVD) is markedly increased among hemodialysis (HD) patients. Optimizing blood pressure (BP) among HD patients may present an important opportunity to reduce the disparity in CVD rates between HD patients and the general population. The optimal target predialysis systolic BP (SBP) among HD patients is unknown. Current international guidelines, calling for a predialysis SBP < 140 mm Hg, are based on the opinion and extrapolation from the general population. Existing randomized controlled trials (RCTs) were small and did not include prespecified BP targets.The authors described the design of the Blood Pressure in Dialysis (BID) Study, a pilot, multicenter RCT where HD patients are randomized to either a target-standardized predialysis SBP of 110 to 140 mm Hg or 155 to 165 mm Hg. This is the first study to randomize HD patients to 2 different SBP targets.Primary outcomes are feasibility and safety. Feasibility parameters include recruitment and retention rates, adherence with prescribed BP measurements and achievement and maintenance of selected BP targets. Safety parameters include rates of hypotension and other adverse and serious adverse events. The authors obtained preliminary data on changes in left ventricular mass, aortic pulse wave velocity, vascular access thromboses and health-related quality of life across study arms, which may be the secondary outcomes in the full-scale study.The data acquired in the pilot RCT will determine the feasibility and safety and inform the design of a full-scale trial, powered for hard outcomes, which may require 2000 participants.

SUBMITTER: Gul A

PROVIDER: S-EPMC3647384 | biostudies-other | 2014 Feb

REPOSITORIES: biostudies-other

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Design of the Blood Pressure Goals in Dialysis pilot study.

Gul Ambreen A Miskulin Dana D Gassman Jennifer J Harford Antonia A Horowitz Bruce B Chen Joline J Paine Susan S Bedrick Edward E Kusek John W JW Unruh Mark M Zager Philip P

The American journal of the medical sciences 20140201 2

<h4>Background</h4>Cardiovascular disease (CVD) is markedly increased among hemodialysis (HD) patients. Optimizing blood pressure (BP) among HD patients may present an important opportunity to reduce the disparity in CVD rates between HD patients and the general population. The optimal target predialysis systolic BP (SBP) among HD patients is unknown. Current international guidelines, calling for a predialysis SBP < 140 mm Hg, are based on the opinion and extrapolation from the general populatio ...[more]

PMID: 23377167

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Project description:BackgroundHypertension affects 1 in 5 Canadians and is the leading cause of morbidity and mortality globally. Hypertension control is declining due to multiple factors including lack of access to primary care. Consequently, patients with hypertension frequently visit the emergency department (ED) due to high blood pressure (BP). Telehealth for Emergency-Community Continuity of Care Connectivity via Home-Telemonitoring Blood Pressure is a pilot project that implements and evaluates a comprehensive home blood pressure telemonitoring (HBPT) and physician case management protocol designed as a postdischarge management strategy to support patients with asymptomatic elevated BP as they transition from the ED to home.ObjectiveOur objective was to conduct a feasibility study of an HBPT program for patients with asymptomatic elevated BP discharged from the ED.MethodsPatients discharged from an urban, tertiary care hospital ED with asymptomatic elevated BP were recruited in Vancouver, British Columbia, Canada, and provided with HBPT technology for 3 months of monitoring post discharge and referred to specialist hypertension clinics. Participants monitored their BP twice in the morning and evenings and tele-transmitted readings via Bluetooth Sensor each day using an app. A monitoring clinician received these data and monitored the patient's condition daily and adjusted antihypertensive medications. Feasibility outcomes included eligibility, recruitment, adherence to monitoring, and retention rates. Secondary outcomes included proportion of those who were defined as having hypertension post-ED visits, changes in mean BP, overall BP control, medication adherence, changes to antihypertensive medications, quality of life, and end user experience at 3 months.ResultsA total of 46 multiethnic patients (mean age 63, SD 17 years, 69%, n=32 women) found to have severe hypertension (mean 191, SD 23/mean 100, SD 14 mm Hg) in the ED were recruited, initiated on HBPT with hypertension specialist physician referral and followed up for 3 months. Eligibility and recruitment rates were 40% (56/139) and 88% (49/56), respectively. The proportion of participants that completed ≥80% of home BP measurements at 1 and 3 months were 67% (31/46) and 41% (19/46), respectively. The proportion of individuals who achieved home systolic BP and diastolic BP control at 3 months was 71.4% (30/42) and 85.7% (36/42) respectively. Mean home systolic and diastolic BP improved by -13/-5 mm Hg after initiation of HBPT to the end of the study. Patients were prescribed 1 additional antihypertensive medication. No differences in medication adherence from enrollment to 3 months were noted. Most patients (76%, 25/33) were highly satisfied with the HBPT program and 76% (25/33) found digital health tools easy to use.ConclusionsHBPT intervention is a feasible postdischarge management strategy and can be beneficial in supporting patients with asymptomatic elevated BP from the ED. A randomized trial is underway to evaluate the efficacy of this intervention on BP control.

Project description:BackgroundMortality is extremely high immediately after the transition to dialysis therapy, but the association of blood pressure (BP) before dialysis therapy initiation with mortality after dialysis therapy initiation remains unknown.Study designObservational study.Setting & participants17,729 US veterans transitioning to dialysis therapy in October 2007 to September 2011, with a median follow-up of 2.0 years.PredictorSystolic (SBP) and diastolic BP (DBP) averaged over the last 1-year predialysis transition period as 6 (<120 to ≥160mmHg in 10-mmHg increments) and 5 (<60 to ≥90mmHg in 10-mmHg increments) categories, respectively, and as continuous measures.Outcomes & measurementsPostdialysis all-cause mortality, assessed over different follow-up periods (ie, <3, 3-<6, 6-<12, and ≥12 months after dialysis therapy initiation) using Cox regressions adjusted for demographics, comorbid conditions, medications, cardiovascular medication adherence, body mass index, estimated glomerular filtration rate, and type of vascular access.ResultsMean predialysis SBP and DBP were 141.2±16.1 (SD) and 73.7±10.6mmHg, respectively. There was a reverse J-shaped association of SBP with all-cause mortality, with significantly higher mortality seen with SBP<140mmHg. Mortality risks associated with lower SBP were greatest in the first 3 months after dialysis therapy initiation, with multivariable-adjusted HRs of 2.40 (95% CI, 1.96-2.93), 1.99 (95% CI, 1.66-2.40), 1.35 (95% CI, 1.13-1.62), 0.98 (95% CI, 0.78-1.22), and 0.76 (95% CI, 0.57-1.00) for SBP <120, 120 to <130, 130 to <140, 150 to <160, and ≥160 (vs 140-<150) mmHg, respectively. No consistent association was observed between predialysis DBP and postdialysis mortality.LimitationsResults cannot be inferred to show causality and may not be generalizable to women or the general US population.ConclusionsLower predialysis SBP is associated with higher all-cause mortality in the immediate postdialysis period. Predialysis DBP showed no consistent association with postdialysis mortality. Further studies are needed to clarify ideal predialysis SBP levels among incident dialysis patients as a potential means to improve the excessively high early dialysis mortality.

Project description:People with prehypertension (120-130/80-90 mmHg) are at increased risk of progressing to hypertension. Recommendations for prehypertension include engaging in regular physical activity. We aimed to assess feasibility and acceptability and collect preliminary outcome data on ChiRunning for people with elevated blood pressure. ChiRunning is a commercially available running program based on the mindful movements of Tai Chi, which is aimed at decreasing injury by both increasing body awareness and modifying running form.We enrolled adults with elevated systolic (130-150 mmHg) or diastolic (80-100 mmHg) blood pressure in a 12-week pilot trial. Participants were randomized 2:1:1 to 8 weeks of: 1) intervention-a trainer-led ChiRunning group (n?=?10); 2) active control-a trainer-led running group (n?=?6); or 3) educational control-a self-directed running group (n?=?6) and followed for 4 more weeks. The active control and educational control groups were combined for analysis.This study was feasible, meeting recruitment, retention and adherence goals, and acceptable to participants. Systolic and diastolic blood pressure did not change significantly over the study for either the ChiRunning or control groups. Changes in BMI over time were significantly different from zero in the ChiRunning group (p?=?0.04) but not in the control group (slope for ChiRunning -0.05 [-0.1 to -0.002] vs. control -0.01 [-0.06 to 0.04], between slope difference, p?=?0.22). Self-reported running-related injury (i.e. discomfort leading to a decrease in running) was similar between groups (ChiRunning, 4 [1.2 to 8.4] vs. control, 3 [0.7 to 7.1] injuries per 100 h of running, p?=?0.72) although self-reported running-related discomfort (i.e. discomfort that does not lead to changes in running) trended higher in the ChiRunning group (ChiRunning, 10 [5.4 to 16.8] vs. control, 4 [1.5 to 9] reports of discomfort per 100 h of running, p?=?0.06).ChiRunning appears to be a feasible and acceptable exercise program for people with elevated blood pressure. We did not find that ChiRunning had a significant impact on blood pressure or self reported injury, but did see a positive change in BMI over time. ChiRunning warrants further investigation in a larger trial.ClinicalTrials.gov Identifier: NCT01587183.

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Design of the Blood Pressure Goals in Dialysis pilot study.

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Design of the Blood Pressure Goals in Dialysis pilot study.

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