comparison of three combinations of two blood pressure lowering drugs on central arterial stiffness and pressure in patients with hypertensio

Not Applicable

• Conditions: Health Condition 1: I10- Essential (primary) hypertension

• Registration Number: CTRI/2022/11/047463
• Lead Sponsor: Imperial College of London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Patients with Sitting clinic values of Systolic blood pressure between 140 mmHg and 160 mmHg on one antihypertensive agent OR

2. Patient with Sitting clinic values of Systolic Blood Pressure between 150 mmHg and 180 mmHg on no antihypertensive treatment

Exclusion Criteria

1. Congestive heart failure (clinically defined).

2. Patients with a history of intolerance to any of the study medications for example angioedema or dry cough with ACE-inhibitors.

3. Serum creatinine levels greater than 132.6 µmol/l (1.5mg/dl)

4. History of coronary heart disease (i.e chronic stable angina, myocardial infarction or acute coronary syndrome).

5. History of a stroke or other cerebrovascular accident (i.e. transient ischaemic attack or reversible ischaemic neurological deficit).

6. Severe hepatic impairment

7. Treatment with agents causing torsades de pointes

8. Lactation

9. Contraindications to any of the investigational medicinal products as per the SmPc of drugs studied

10. Known or suspected secondary hypertension.

11. Any other concomitant illness, physical or mental impairment that could interfere with the effective conduct of the study.

12. Pregnancy or those of child-bearing age who are not taking reliable contraception.

13. History of Gout.

14. Serum potassium less than 3.5mmol/L at screening.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in aortic stiffness by measuring carotid to femoral pulse wave velocity (cf-PWV)Timepoint: At baseline, 2 month, 4 month and 6 month

Secondary Outcome Measures

Name	Time	Method
Change in biochemical markers of oxidative stress and MMP-2 & 9Timepoint: Changes from baseline to 2,4 and 6 months;Changes in central arterial blood pressure (carotid artery)Timepoint: Changes in central arterial blood pressure from baseline to 2,4 and 6 months;Changes in local carotid arterial stiffnessTimepoint: Changes in local carotid stiffness from baseline to 2,4 and 6 months