Blood pressure control and treatment adherence in hypertensive patients with metabolic syndrome: protocol of a randomized controlled study based on home blood pressure telemonitoring vs. conventional management and assessment of psychological determinants of adherence (TELEBPMET Study).

BACKGROUND: Inadequate blood pressure control and poor adherence to treatment remain among the major limitations in the management of hypertensive patients, particularly of those at high risk of cardiovascular events. Preliminary evidence suggests that home blood pressure telemonitoring (HBPT) might help increasing the chance of achieving blood pressure targets and improve patient's therapeutic adherence. However, all these potential advantages of HBPT have not yet been fully investigated. METHODS/DESIGN: The purpose of this open label, parallel group, randomized, controlled study is to assess whether, in patients with high cardiovascular risk (treated or untreated essential arterial hypertension--both in the office and in ambulatory conditions over 24 h--and metabolic syndrome), long-term (48 weeks) blood pressure control is more effective when based on HBPT and on the feedback to patients by their doctor between visits, or when based exclusively on blood pressure determination during quarterly office visits (conventional management (CM)). A total of 252 patients will be enrolled and randomized to usual care (n = 84) or HBPT (n = 168). The primary study endpoint will be the rate of subjects achieving normal daytime ambulatory blood pressure targets (< 135/85 mmHg) 24 weeks and 48 weeks after randomization. In addition, the study will assess the psychological determinants of adherence and persistence to drug therapy, through specific psychological tests administered during the course of the study. Other secondary study endpoints will be related to the impact of HBPT on additional clinical and economic outcomes (number of additional medical visits, direct costs of patient management, number of antihypertensive drugs prescribed, level of cardiovascular risk, degree of target organ damage and rate of cardiovascular events, regression of the metabolic syndrome). DISCUSSION: The TELEBPMET Study will show whether HBPT is effective in improving blood pressure control and related medical and economic outcomes in hypertensive patients with metabolic syndrome. It will also provide a comprehensive understanding of the psychological determinants of medication adherence and blood pressure control of these patients. TRIAL REGISTRATION: Clinical Trials.gov: NCT01541566.

Cardiovascular risk assessment beyond Systemic Coronary Risk Estimation: a role for organ damage markers.

BACKGROUND: Cardiovascular risk assessment in the clinical practice is mostly based on risk charts, such as Framingham risk score and Systemic Coronary Risk Estimation (SCORE). These enable clinicians to estimate the impact of cardiovascular risk factors and assess individual cardiovascular risk profile. Risk charts, however, do not take into account subclinical organ damage, which exerts independent influence on risk and may amplify the estimated risk profile. Inclusion of organ damage markers in the assessment may thus contribute to improve this process. OBJECTIVE: Our aim was to evaluate the influence of implementation of SCORE charts with widely available indexes of organ damage, with the purpose to ameliorate individual risk assessment. METHODOLOGY: We searched www.Pubmed.gov for evidence about the predictive value of left ventricular hypertrophy (LVH), estimated glomerular filtration rate (eGFR), microalbuminuria (MAU) and metabolic syndrome on different risk profiles estimated by SCORE. Interventional and observational trials including at least 200 patients and published after 2000 were selected. RESULTS: The presence of organ damage as well as the number of abnormal parameters indicating organ damage is associated with increased cardiovascular risk, independently of SCORE. In the area of high risk, the impact of different markers of organ damage is heterogeneous. Combined risk models of SCORE and subclinical organ damage have major impact on risk stratification and may impact on recommendation in primary prevention in all SCORE categories. CONCLUSION: Available evidence suggests a tangible clinical advantage of adding the evaluation of simple organ damage markers to risk charts in cardiovascular risk prediction.

Reduction in estimated stroke risk associated with practice-based stroke-risk assessment and awareness in a large, representative population of hypertensive patients: results from the ForLife study in Italy.

OBJECTIVE: A previous analysis of the ForLife study demonstrated a high estimated risk of stroke, poor blood pressure control and higher cardiovascular risk. Data from a subsequent visit within 6 months, to evaluate the impact of systematic stroke risk assessment, are reported. METHODS: Between February and July 2003, 1800 general practitioners (GPs) recruited a total of 12,792 (7512 untreated and 5280 treated) patients with hypertension. Blood pressure values were assessed in the whole study population, and for different demographic and clinical features in two visits within 6 months. The data were recorded into a Framingham-based stroke risk score and computed using a risk calculator. RESULTS: Between the two visits the percentage of patients with controlled blood pressure (< 140/90 mmHg) increased substantially in all subgroups, being greater in patients who were not treated at baseline. Among initially treated patients, the greater control of blood pressure involved both diastolic and systolic values. The percentage of patients with diabetes whose blood pressure levels were less than 130/80 mmHg also increased at the second visit. Between the two visits the estimated stroke risk score showed a reduction, with a significant shift of patients from high to intermediate and low-risk categories. This reduction involved all subgroups, including patients with diabetes and left ventricular hypertrophy. CONCLUSION: The present large-scale observational study demonstrates that the assessment of stroke risk and increased awareness of stroke risk factors by GPs is associated with improved blood pressure control, reduced cardiovascular risk profile and a prompt reduction in the 10-year estimated risk of stroke.