Lý do và thiết kế của thử nghiệm các thuốc chống tăng huyết áp và chức năng mạch máu, nội mô, và nhận thức (AVEC) ở người cao tuổi mắc tăng huyết áp với suy giảm nhận thức sớm: Vai trò của việc ức chế hệ thống renin-angiotensin

BMC Geriatrics - 2009
Ihab Hajjar1,2,3, Meaghan Hart3, William Milberg1,4, Vera Novak1,2, Lewis Lipsitz1,3,2
1Harvard Medical School, Boston, USA;
2Division of Gerontology, Beth Israel Deaconess Medical Centre, Boston, USA
3Institue for Aging Research, Hebrew SeniorLife, Boston, USA
4GRECC VA Boston Healthcare, Boston, USA

Tóm tắt

Các bằng chứng trước đây cho thấy rằng hệ thống renin-angiotensin và các thuốc chống tăng huyết áp ức chế hệ thống này có vai trò trong chức năng nhận thức, mạch máu trung ương, và chức năng nội mô. Mục tiêu của chúng tôi là thực hiện một thử nghiệm lâm sàng ngẫu nhiên có đối chứng hai mù, thử nghiệm các thuốc chống tăng huyết áp và chức năng mạch máu, nội mô, và nhận thức (AVEC), để so sánh tác động của 3 loại thuốc chống tăng huyết áp (lisinopril, candesartan, hoặc hydrochlorothiazide) trong một năm điều trị đối với trí nhớ và chức năng điều hành, lưu lượng máu não, và chức năng nội mô trung ương ở người cao tuổi mắc tăng huyết áp và có bằng chứng khách quan sớm về suy giảm chức năng điều hành hoặc trí nhớ. Thiết kế thử nghiệm tổng thể của thử nghiệm AVEC là một thử nghiệm lâm sàng ngẫu nhiên có đối chứng hai mù với 3 nhánh. Tổng cộng 100 cá nhân đủ điều kiện trong cộng đồng (60 tuổi trở lên) mắc tăng huyết áp và suy giảm nhận thức sớm đang được tuyển chọn từ khu vực Boston lớn và được ngẫu nhiên chia thành nhóm sử dụng lisinopril, candesartan hoặc hydrochlorothiazide ("kiểm soát tích cực") trong 12 tháng. Mục tiêu của can thiệp là đạt được kiểm soát huyết áp được định nghĩa là huyết áp tâm thu (SBP) < 140 mm Hg và huyết áp tâm trương (DBP) < 90 mm Hg. Các thuốc chống tăng huyết áp bổ sung sẽ được thêm vào để đạt được mục tiêu này nếu cần thiết. Những người tham gia đủ điều kiện là những người mắc tăng huyết áp, được định nghĩa là huyết áp 140/90 mm Hg hoặc cao hơn, có suy giảm nhận thức sớm mà không có triệu chứng sa sút trí tuệ được định nghĩa (10 điểm trở xuống trong bài kiểm tra vẽ đồng hồ điều hành hay 1 độ lệch chuẩn dưới mức trung bình trong bài phụ của bộ lặp để đánh giá tình trạng tâm thần kinh và bài kiểm tra điểm số trạng thái tâm thần mini >20 và không có chẩn đoán lâm sàng về sa sút trí tuệ hoặc bệnh Alzheimer). Các cá nhân hiện đang sử dụng thuốc chống tăng huyết áp cũng đủ điều kiện nếu họ và các nhà cung cấp dịch vụ chăm sóc chính sẵn sàng giảm liều thuốc chống tăng huyết áp. Người tham gia sẽ trải qua đánh giá nhận thức, đo lưu lượng máu não bằng phương pháp Doppler xuyên sọ, và chức năng nội mô trung ương bằng cách đo những thay đổi trong lưu lượng máu não khi thay đổi nồng độ carbon dioxide trong khí thở ra ở thời điểm ban đầu (không dùng thuốc chống tăng huyết áp), 6, và 12 tháng. Các kết quả của chúng tôi bao gồm thay đổi trong điểm số chức năng nhận thức (điều hành và trí nhớ), lưu lượng máu não, và phản ứng mạch não với carbon dioxide. Thử nghiệm AVEC là nghiên cứu đầu tiên探索 tác động của các thuốc chống tăng huyết áp ở những người đang có những dấu hiệu suy giảm nhận thức sớm mà chưa đạt ngưỡng sa sút trí tuệ. Thành công của thử nghiệm này sẽ cung cấp ứng dụng điều trị mới cho các thuốc chống tăng huyết áp ức chế hệ thống renin-angiotensin và những hiểu biết mới về vai trò của hệ thống này trong quá trình lão hóa. Clinicaltrials.gov NCT00605072

Từ khóa


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The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2318/9/48/prepub

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BMC Geriatrics

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