Hypertension
Conditions
Keywords
blood pressure variability, nitrendipine, atenolol
Brief 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.
Detailed description
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.
Interventions
DRUGNitrendipine/Atenolol
Nitrendipine/Atenolol 5mg/10mg single-pill combination, oral tablet, one pill daily.
DRUGNitrendipine
Nitrendipine 5mg, oral tablet, one pill daily.
DRUGAtenolol
Atenolol 25mg, oral tablet, one pill daily.
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ambulatory systolic blood pressure variability 1 | The first 6 weeks of treatment. | Including the average real variability (ARV), the coefficient of variation (CV),and the standard deviation (SD). |
| Ambulatory systolic blood pressure variability 2 | The second 6 weeks of cross-over treatment. | Including the average real variability (ARV), the coefficient of variation (CV),and the standard deviation (SD). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ambulatory diastolic blood pressure variability 1 | The first 6 weeks of treatment. | Including the average real variability (ARV), the coefficient of variation (CV),and the standard deviation (SD). |
| Ambulatory diastolic blood pressure variability 2 | The second 6 weeks of cross-over treatment. | Including the average real variability (ARV), the coefficient of variation (CV),and the standard deviation (SD). |
| Ambulatory blood pressure 1 | The first 6 weeks of treatment. | Including ambulatory blood pressure over 24 hours, daytime and nighttime. |
| Ambulatory blood pressure 2 | The second 6 weeks of cross-over treatment. | Including ambulatory blood pressure over 24 hours, daytime and nighttime. |
Countries
China
Contacts
Primary ContactJiguang Wang, MD, PhD
Outcome results
None listed