Feasibility Study of the Intensive Systolic Blood Pressure Control

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Affiliated Hospital of Nanchang University
• Collaborator: Peking University First Hospital
• Treatments: Adrenergic beta-Antagonists; Amlodipine; Antihypertensive Agents; Diuretics; Enalapril; Enalaprilat; Folic Acid; Hydrochlorothiazide; Vitamin B Complex

Criteria

Inclusion criteria:

• Hypertensive patients aged 60 years or older.

• SBP>= 150 mmHg but <180 mmHg, if currently (within the previous two weeks) not regularly treated with antihypertensive drugs.

• If currently (at least 10 days on medications within the previous two weeks) regularly treated with antihypertensive drugs, blood pressure must meet the following criteria:

SBP >= 140 mmHg but <170 mmHg, if regularly (no less than 10 days) taking 1 type of antihypertensive medication within the previous two weeks; SBP >= 130 mmHg but <160 mmHg, if regularly (no less than 10 days) taking 2 types of antihypertensive medications within the previous two weeks; SBP >= 130 mmHg but <150 mmHg, if regularly (no less than 10 days) taking 3 types of antihypertensive medication within the previous two weeks.

For patients taking a fixed-dose-combination (FDC), this treatment will be considered as two types of drugs if the dose of each component of the FDC is equal to higher than the routine therapeutic dose.

• Blood homocysteine (Hcy)≥ 10μmol/L, or the patient is taking enalapril-folic acid;

• Subject has read and signed a written, informed consent form.

Exclusion Criteria:

• History of physician diagnosed stroke, myocardial infarction, heart failure, revascularization, or malignancy;

• Clearly diagnosed secondary hypertension;

• Undergoing regular renal dialysis or has been diagnosed with end-stage kidney disease;

• Congenital or acquired organic heart disease;

• Severe somatic disease preventing the participant from completing the trial, or based on the discretion of the investigators, the patient is incapable of participating;

• Contraindicated or intolerable to ACEIs (including enalapril-folic acid) or a history of severe adverse effects to ACEIs;

• Individuals with abnormal laboratory test results and/or clinical manifestations rendering them unsuitable to participate as judged by the investigators;

• Any factor likely to limit adherence to interventions or jeopardize data collection, for example: dementia, severe mental disorders impeding expression or communication abilities, an inability to adhere the follow-up plan, plans to move in the near future, or, a history of unreliability in following a medication regimen or in keeping appointments;

• Living with a family member (a spouse, for example) who has already participated in the study;

• Unwilling to participate, unwilling or unable to change current therapeutic regimen;

• Currently (or within one month) participating in another new drug trial.