Hypertension Clinical Trial
Official title:
Effects of Intensive Antihypertensive Therapies on the Risk of Stroke in Hypertensive Adults: A Prospective Randomized Open-Label Blinded-Endpoint Trial, a Feasibility Study
The purpose of the current feasibility study is to test whether the blood pressure level of the study patients can be effectively and safely managed according to the intensive antihypertensive treatment protocol. Furthermore, the study will also examine the effect of intensive antihypertensive treatment on the intermediate cardiovascular diseases outcomes, including CIMT, carotid plaques, PWV ABI, and kidney function, etc.
The China Stroke Primary Prevention Trial (CSPPT, NCT00794885) found that among hypertensive
adults in China without a history of stroke or myocardial infarction, the combined use of
enalapril and folic acid, compared with enalapril alone, significantly reduced the risk of
first stroke. The mean systolic blood pressures were highly comparable between the two
groups over the course of the trial (139.7mmHg and 139.8mmHg, respectively, in the
enalapril-folic acid and the enalapril group). In the further analysis, lower systolic blood
pressures seemed to be associated with greater reduction in cardiovascular outcomes in both
of the treatment groups.
However, due to inconsistencies in the results of the ACCORD and SPRINT trials, the
appropriate targets for systolic blood pressure in effectively reducing cardiovascular
events among hypertensive patients remain uncertain.
The proposed trial aims to test the hypothesis that among hypertensive patients aged 60
years or older, a lower systolic blood pressure goal will lead to greater reduction in
stroke incidence.
The current feasibility study aims to test whether the blood pressure level of the study
patients can be effectively and safely managed according to the intensive antihypertensive
treatment protocol. Furthermore, the study will also examine the effect of intensive
antihypertensive treatment on the intermediate cardiovascular diseases outcomes, including
CIMT, carotid plaques, PWV ABI, and kidney function, etc.
The current feasibility study will enroll approximately 100 patients with H-type
hypertension (hypertensive patients with hyperhomocysteinemia) aged 60 years or older, and
without a history of major cardiovascular diseases.
Eligible patients will randomly assigned to one of three different systolic blood pressure
(SBP) target groups (Group A, SBP: 140 - <150 mmHg; Group B, SBP: 130 - < 140 mmHg; and
Group C, SBP < 130 mmHg).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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