NCT02817503

Feasibility Study of the Intensive Systolic Blood Pressure Control

Effects of Intensive Antihypertensive Therapies on the Risk of Stroke in Hypertensive Adults: A Prospective Randomized Open-Label Blinded-Endpoint Trial, a Feasibility Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Second Affiliated Hospital of Nanchang University · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Hypertension
• Hyperhomocysteinemia

Interventions

Type	Name	Description
DRUG	Standard BP control	Enalapril-folic acid will be used as an initial therapy. Other drugs, including CCB (amlodipine preferred), diuretics (hydrochlorothiazide preferred), and β-blockers, are allowed, in order to achieve the SBP target.
DRUG	Moderate BP control	Enalapril-folic acid will be used as an initial therapy. Other drugs, including CCB (amlodipine preferred), diuretics (hydrochlorothiazide preferred), and β-blockers, are allowed, in order to achieve the SBP target.
DRUG	Intensive BP control	Enalapril-folic acid will be used as an initial therapy. Other drugs, including CCB (amlodipine preferred), diuretics (hydrochlorothiazide preferred), and β-blockers, are allowed, in order to achieve the SBP target.

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2016-06-29
• Last updated: 2016-10-14

Locations

1 site across 1 country: China