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

Last updated: April 11, 2023
Sponsor: Shanghai Jiao Tong University School of Medicine
Overall Status: Active - Recruiting

Phase

4

Condition

Stress

Circulation Disorders

Vascular Diseases

Treatment

N/A

Clinical Study ID

NCT04931108
NAC-BPV
  • Ages 30-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Men or Women.
  • Aged 30-65 years.
  • Ambulatory systolic blood pressure ≥ 135 mmHg and/or diastolic blood pressure ≥ 85mmHg.
  • Ambulatory daytime systolic blood pressure standard deviation (SD)≥13mmHg.
  • Never took antihypertensive drugs.
  • Signed the written consent.

Exclusion

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.

Study Design

Total Participants: 32
Study Start date:
September 27, 2021
Estimated Completion Date:
June 30, 2023

Study 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.

Connect with a study center

  • Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai 200025
    China

    Active - Recruiting

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