Personalized E-Coaching in Cardiovascular Risk Reduction: A Randomized Controlled Trial.

OBJECTIVES: To assess whether electronic (e-) coaching, using personalized web-based lifestyle and risk factor counselling with additional email prompts, provides additional risk reduction when added to standard of care (SOC) in individuals at increased risk. METHODS: Between June 2013 and May 2015, 402 participants were allocated 1:1 to e-coaching and SOC versus SOC. Participants free of manifest cardiovascular disease, with internet access, and a 10-year QRISK2 cardiovascular risk of ≥10% were enrolled. Change in oscillometric carotid-femoral pulse wave velocity (PWV) from baseline to six months was the primary endpoint. Secondary outcomes included change in blood pressure (BP), weight, and risk scores. Analysis was by intention to treat. RESULTS: Mean (±SD) age was 65.5 (5.6) years with 37% females. Primary outcome data were available for 94%. There was no difference in PWV reductions between e-coaching and standard of care groups (-0.16 m/s vs. -0.25 m/s, 95% confidence interval -0.39 to 0.22, p = 0.56). There were no differences in the improvement between groups for BP, weight, Framingham, or QRISK2 scores. Pulse wave velocity change was more favorable in those with a higher level of education (p = 0.04), but was not associated with age, gender, presence of diabetes, baseline QRISK2 score, or logins to the website. CONCLUSIONS: In individuals at increased cardiovascular risk, a comprehensive 'health check' program modestly reduced future risk. Personalized e-coaching did not provide added risk reduction. Currently there is no evidence to routinely recommend e-coaching in cardiovascular health check programs. TRIAL REGISTRATION: HAPPY London ClinicalTrials.gov: NCT01911910.

Attenuation of Splanchnic Autotransfusion Following Noninvasive Ultrasound Renal Denervation: A Novel Marker of Procedural Success.

BACKGROUND: Renal denervation has no validated marker of procedural success. We hypothesized that successful renal denervation would reduce renal sympathetic nerve signaling demonstrated by attenuation of α-1-adrenoceptor-mediated autotransfusion during the Valsalva maneuver. METHODS AND RESULTS: In this substudy of the Wave IV Study: Phase II Randomized Sham Controlled Study of Renal Denervation for Subjects With Uncontrolled Hypertension, we enrolled 23 subjects with resistant hypertension. They were randomized either to bilateral renal denervation using therapeutic levels of ultrasound energy (n=12) or sham application of diagnostic ultrasound (n=11). Within-group changes in autonomic parameters, office and ambulatory blood pressure were compared between baseline and 6 months in a double-blind manner. There was significant office blood pressure reduction in both treatment (16.1±27.3 mm Hg, P<0.05) and sham groups (27.9±15.0 mm Hg, P<0.01) because of which the study was discontinued prematurely. However, during the late phase II (Iii) of Valsalva maneuver, renal denervation resulted in substantial and significant reduction in mean arterial pressure (21.8±25.2 mm Hg, P<0.05) with no significant changes in the sham group. Moreover, there were significant reductions in heart rate in the actively treated group at rest (6.0±11.5 beats per minute, P<0.05) and during postural changes (supine 7.2±8.4 beats per minute, P<0.05, sit up 12.7±16.7 beats per minute, P<0.05), which were not observed in the sham group. CONCLUSIONS: Blood pressure reduction per se is not necessarily a marker of successful renal nerve ablation. Reduction in splanchnic autotransfusion following renal denervation has not been previously demonstrated and denotes attenuation of (renal) sympathetic efferent activity and could serve as a marker of procedural success. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02029885.