the effect of nitrendipine/atenolol combination on blood pressure variability.

Conditions: Hypertension

Summary: 1. study name: the effect of nitrendipine/atenolol combination on blood pressure variability. 2. medicine: nitrendipine/atenolol; nitrendipine; atenolol. 3. rationale: blood pressure variability correlates with cardiovascular events and target-organ damage in hypertensive patients. nitrendipine/atenolol has obvious advantages in reducing blood pressure variability in hypertensive rats, but the effect of this combination on hypertensive patients is still unknown. 4. objective: to evaluate the effect of nitrendipine/atenolol on blood pressure variability of patients with grade 1 hypertension compared with nitrendipine or atenolol monotherapy. 5. study design: this study is a cross-over, randomized, controlled clinical trial with two equally sized treatment groups: nitrendipine/atenolol (5mg/10mg); nitrendipine (10mg) or atenolol (25mg). 6. study population: men and women aged 30-65 years (n=32) meeting the inclusion/exclusion criteria. 7. randomization and cross-over design: eligible patients will be randomly divided into two groups. half of patients will take nitrendipine/atenolol (5/10mg) once daily for 6 weeks first, and then evenly turn into nitrendipine (10mg) or atenolol (25mg) once daily for 6 weeks. another half of patients will evenly take nitrendipine (10mg) or atenolol (25mg) first, and turn into nitrendipine/atenolol (5/10mg) next. 8. follow up: 14 weeks. 9. sample size: a total of 32 patients should be enrolled. 10. timeline: after obtaining the approval of ethics committee of ruijin hospital in april 2021, recruitment will start. patients enrollment and follow-up will be performed between june 2021 to june 2022.

1. study name: the effect of nitrendipine/atenolol combination on blood pressure variability of patients with grade 1 hypertension compared with nitrendipine or atenolol monotherapy. 2. medicine: nitrendipine/atenolol (5/10mg tablet); nitrendipine (10mg tablet); atenolol (25mg tablet) 3. rationale: blood pressure variability correlates with cardiovascular events and target-organ damage in hypertensive patients. nitrendipine/atenolol has obvious advantages in reducing blood pressure variability in hypertensive rats, but the effect of this combination on hypertensive patients is still unknown. 4. objective: to evaluate the effect of nitrendipine/atenolol on blood pressure variability of patients with grade 1 hypertension compared with nitrendipine or atenolol monotherapy. 5. study design: this study is a cross-over, randomized, controlled clinical trial with two equally sized treatment groups: nitrendipine/atenolol (5mg/10mg); nitrendipine (10mg) or atenolol (25mg). 6. study population: eligible patients (n=32) should be men or women aged 30-65 years. untreated patients diagnosed as essential hypertension, whose daytime systolic blood pressure ≥ 135mmhg and/or daytime diastolic blood pressure ≥ 85mmhg, and standard deviation (sd)≥13mmhg will be recruited. 7. randomization and cross-over design: eligible patients will be randomly divided into two groups. half of patients will take nitrendipine/atenolol (5/10mg) once daily for 6 weeks first, and then evenly turn into nitrendipine (10mg) or atenolol (25mg) once daily for 6 weeks. another half of patients will evenly take nitrendipine (10mg) or atenolol (25mg) first, and turn into nitrendipine/atenolol (5/10mg) next. 8. follow up: 14 weeks. 1 week for screening period, 6 weeks for the first period of treatment, 1 week for wash-out period, and 6 weeks for the second period of treatment. 9. sample size: a total of 32 patients should be enrolled. 10. timeline: after obtaining the approval of ethics committee of ruijin hospital in april 2021, recruitment will start. patients enrollment and follow-up will be performed between june 2021 to june 2022. 11. organization: the centre for epidemiological studies and clinical trials, ruijin hospital, shanghai, china.

Eligibility criteria:
inclusion criteria: * men or women. * aged 30-65 years. * ambulatory systolic blood pressure ≥ 135 mmhg and/or diastolic blood pressure ≥ 85 mmhg. * ambulatory daytime systolic blood pressure standard deviation (sd)≥13mmhg. * never took antihypertensive drugs. * signed the written consent. exclusion criteria: * under antihypertensive treatments. * clinic systolic blood pressure ≥ 160mmhg and/or diastolic blood pressure ≥ 100mmhg. * contraindications to the treatment of drugs, including hypersensitivity reaction, bradycardia, asthma, etc. * any cardiovascular disease except hypertension. * suspected or confirmed secondary hypertension. * poor compliance.

Keywords: blood pressure variability nitrendipine atenolol