Observational study assessing early markers of high blood pressure mediated brain damage and the impact of single-pill treatment with Perindopril/Indapamide

Not Applicable

Completed

• Conditions: Arterial hypertension; Circulatory System

• Registration Number: ISRCTN67799751
• Lead Sponsor: Sechenov University

Brief Summary

2020 results in https://pubmed.ncbi.nlm.nih.gov/33026579/ (added 08/10/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-12-15
• Study Start: 2020-02-06
• Last Update Posted: 19 October 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Hypertension group:
1. Age 40-59 years
2. Office SBP – 140–179 mmHg and/or DBP – 90–109 mmHg
3. Presence of at least one hypertension-mediated organ damage (heart – left ventricular hypertrophy assessed by echocardiogram, blood vessels – atherosclerotic plaques assessed by triplex scanning of the brachiocephalic arteries, kidneys – microalbuminuria and/or glomerular filtration rate according to CKD-EPI between 30-60 ml/min/1.73 m²)
4. Lack of antihypertensive treatment

Control group
1. Healthy men and women
2. Age 40-59 years
3. Absence of hypertension

Exclusion Criteria

1. Body mass index = 40 kg/m²
2. Pregnancy, lactation
3. Clinically significant heart disease (myocardial infarction, 2nd and 3rd degree atrio-ventricular block without artificial pacemaker, sinoatrial block, sick sinus syndrome, hypertrophic cardiomyopathy, aortic and mitral stenosis, chronic heart failure, angina pectoris)
4. Clinically significant liver disease
5. Clinically significant kidney disease (GFR according to CKD-EPI <30 ml/min / 1.73 m², hemodialysis, anuria)
6. Clinically significant respiratory organ disease (including bronchial asthma and chronic obstructive pulmonary disease)
7. Clinically significant immunological disease
8. Clinically significant endocrine disease (including diabetes mellitus)
9. Secondary hypertension
10. Gout
11. Mental illness and disorders, dementia, drug and alcohol abuse
12. Severe peripheral vascular diseases (including Raynaud's syndrome)
13. Metabolic acidosis
14. Refractory hypokalemia
15. Clinically significant neurological diseases (including stroke and transient ischemic attack)
16. Surgical operation in the previous 3 months (excluding dental or plastic surgery)
17. Use of any medication (including regular intake of antihypertensive treatment) that could have affected the results of the study for 12 weeks before enrollment, at the time of enrollment and until the end of the study

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> At baseline and follow-up<br> 1. Blood pressure measured using sphygmomanometer<br> 2. Cognitive function measured using MoCA, verbal fluency test, TMT (parts A and B), 10-words list learning task, Stroop Color and Word Test<br> 3. Cerebral blood flow measured using fMRI<br>

Secondary Outcome Measures

Name	Time	Method
Fractional anisotropy measured using fMRI at baseline and follow-up