Abstract
Aim to compare the home blood pressure monitoring (HBPM) and visit blood pressure monitoring in a clinical phase I single-arm pilot trial. The 18% sodium substitute salt was used in 43 hypertensives for 8 weeks, and visited once a week, while weekly visit blood (VBP) pressure, daily home blood pressure (HBP) and urine test results before and after intervention were collected. 43 hypertensive patients were recruited, 4 were lost. And enrolled 39 patients for analysis. The VBP were lower than morning HBP and night HBP (P < 0.05). And VBP was good correlated with morning BP (SBP: r = 0.692, P < 0.001, DBP: r = 0.789, P < 0.001) and night BP (SBP: r = 0.571, P < 0.001, DBP: r = 0.738, P < 0.001). The results of mixed linear model analysis showed that patients' visit SBP (− 11.4 mmHg, 95% CI: − 17.0 to − 5.7, P < 0.001), morning home SBP (− 10.0 mmHg, 95% CI: − 16.4 to − 3.6, P = 0.003) and night home SBP (− 10.2 mmHg, 95% CI: − 15.8 to − 4.6, P = 0.001) decreased significantly, after intervention. Both HBP and VBP showed that 18% substitute salt intervention could decrease the blood pressure of hypertensives. Medication led to VBP lower than HBP, but the two still had a good correlation.Trial registration: NCT03226327. Registered 21 July 2017—Retrospectively registered, http://www.clinicaltrials.gov.
Highlights
Blood pressure as a key indicator, choosing a superior approach to measure it will be crucial
What’s more, in the case of relatively high sodium intake, some previous salt-restricted studies have shown that the lower the sodium intake, the lower the blood pressure[11,12,13]
The urine potassium value increased to 61.01 ± 17.26 mmol/L compared with baseline 52.22 ± 19.30 mmol/L, (t = − 2.411, P = 0.021), which increased by 8.79 mmol/L
Summary
The 24-h urinary sodium value was 138.05 ± 57.12 mmol/L lower than the baseline level 151.86 ± 55.93 mmol/L, which decreased by13.82 mmol/L (95% CI: − 8.62 to 36.26) with no significant difference (t = 1.246, P = 0.220). Analysis showed that the difference between the three kinds of blood pressure was statistically significant (SBP: F = 13.220, P < 0.001, DBP: F = 24.729, P < 0.001). The results of mixed linear model analysis showed that patients’ visit SBP (− 11.4 mmHg, 95% CI: − 17.0 to − 5.7, P < 0.001), morning home SBP (− 10.0 mmHg, 95% CI: − 16.4 to − 3.6, P = 0.003) and night home SBP (− 10.2 mmHg, 95% CI: − 15.8 to − 4.6, P = 0.001) decreased significantly, after intervention. Other adverse events included: 1 weeks after intervention, 1 patient had constipation. At the third week of intervention, 2 patients developed fatigue, 2 patients developed dizziness or headache, and 1 patient developed itching in the neck, back and abdomen
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