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

Observational study to assess cognitive functions, white matter hyperintensities, cerebral blood flow and fractional anisotropy in treatment-naive middle-aged hypertensive patients compared to normotensive controls and to assess the impact of 12-weeks single pill Perindopril/Indapamide treatment on those domains to improve personalized antihypertensive therapy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN67799751
Enrollment
140
Registered
2020-02-06
Start date
2016-12-15
Completion date
Unknown
Last updated
2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arterial hypertension Circulatory System

Interventions

All participants undergo a baseline assessment as follows: 1. Neuropsychological assessment (MoCA, verbal fluency test, TMT (parts A and B), 10-words list learning task, Stroop Color a

Sponsors

Sechenov University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
Fractional anisotropy measured using fMRI at baseline and follow-up

Countries

Russian Federation

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 25, 2026