The Effect of Nitrendipine/Atenolol Combination on Blood Pressure Variability of Patients With Grade 1 Hypertension Compared With Nitrendipine or Atenolol Monotherapy.

NAC-BPV

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.

2021-09-27

2023-06-01

2023-06-01

Recruiting

Early phase I

32

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.

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2023-04-14