Feasibility Study of the Intensive Systolic Blood Pressure Control

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02817503
• Other study ID #: 20151BDH80038
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: June 18, 2016
• Last updated: October 13, 2016
• Start date: December 2015
• Est. completion date: December 2016

Study information

• Verified date: October 2016
• Source: Second Affiliated Hospital of Nanchang University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperhomocysteinemia
• Hypertension

Intervention

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

Locations

Country	Name	City	State
China	the People's Hospital of Rongcheng	Rongcheng	Shandong

Sponsors (2)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Nanchang University	Peking University First Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Huo Y, Li J, Qin X, Huang Y, Wang X, Gottesman RF, Tang G, Wang B, Chen D, He M, Fu J, Cai Y, Shi X, Zhang Y, Cui Y, Sun N, Li X, Cheng X, Wang J, Yang X, Yang T, Xiao C, Zhao G, Dong Q, Zhu D, Wang X, Ge J, Zhao L, Hu D, Liu L, Hou FF; CSPPT Investigators.. Efficacy of folic acid therapy in primary prevention of stroke among adults with hypertension in China: the CSPPT randomized clinical trial. JAMA. 2015 Apr 7;313(13):1325-35. doi: 10.1001/jama.2015.2274. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Events related to the intensive blood pressure control, Hypotension, Syncope, Bradycardia or Arrhythmia, Hyperkalemia, Renal Failure		6 months BP titration treatment period	Yes
Other	First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death hospitalization; Hospitalization	6 months BP titration treatment period	during the Randomization and Titration Treatment period	No
Primary	Achieved mean blood pressure levels in each of the treatment groups		6 months BP titration treatment period	No
Secondary	Carotid intima-media thickness (CIMT), Carotid plaques		6 months BP titration treatment period	No
Secondary	Carotid-femoral pulse wave velocity, Brachial-ankle pulse wave velocity		6 months BP titration treatment period	No
Secondary	Ankle brachial index		6 months BP titration treatment period	No
Secondary	Urinary albumin-creatinine ratio		6 months BP titration treatment period	No