The Effect of Nitrendipine/Atenolol Combination on Blood Pressure Variability.
Status:
Not yet recruiting
Trial end date:
2022-06-01
Target enrollment:
Participant gender:
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.