The Effect of Nitrendipine/Atenolol Combination on Blood Pressure Variability.

• Status: Not yet recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Jiao Tong University School of Medicine
• Treatments: Atenolol; Nitrendipine

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.