Targeted LOWering of Central Blood Pressure in patients with hypertension: Baseline recruitment, rationale and design of a randomized controlled trial (The LOW CBP study)
Contemporary Clinical Trials Aug 26, 2017
Sharman JE, et al. – The purpose of this trial was to discern the value of targeted central blood pressure (BP) lowering among patients with hypertension. It was determined that the intervention possibly lowered the left ventricular mass index considerably. This effect displayed the possibility of an independent association with central BP lowering. The yielded results would support the concept of central BP as a significant therapeutic target in hypertension management.
- The design of this study was a multi-centre, randomized, open-label, blinded endpoint trial.
- Recruitment comprised of 308 patients treated for uncomplicated hypertension with controlled brachial BP (<140/90 mmHg) but elevated central BP (≥0.5SD above age- and sex-specific normal values).
- Baseline recruitment was completed.
- Enrollees were allocated to intervention with spironolactone (25 mg/d) or usual care and are being followed over 24 months.
- The primary outcome was left ventricular mass index (using cardiac magnetic resonance imaging).
- Brachial and central BP would be estimated in the clinic, at home over 7-days and by 24-h ambulatory monitoring.
- Analysis of aortic stiffness would be carried out via carotid-to-femoral pulse wave velocity.
- Primary (intention to treat) analysis would investigate the role of central versus brachial BP for predicting changes in left ventricular mass index.
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