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Feasibility Study of the Intensive Systolic Blood Pressure Control

Primary Purpose

Hypertension, Hyperhomocysteinemia

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Standard BP control
Moderate BP control
Intensive BP control
Sponsored by
Second Affiliated Hospital of Nanchang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring hypertension, BP titration, intensive blood pressure control, primary prevention, China, H-type Hypertension

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • the People's Hospital of Rongcheng

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Standard BP control

Moderate BP control

Intensive BP control

Arm Description

SBP within 140 - <150 mmHg. For all participants, 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. For those who can't tolerate enalapril-folic acid well, other types of antihypertensive agents may be used as alternative choices. If the target BP level is not achieved during the Titration or Follow-up periods, adjustment of drug type and dosage will be carried out according to procedures defined in the protocol.

SBP within 130 - <140 mmHg. For all participants, 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. For those who can't tolerate enalapril-folic acid well, other types of antihypertensive agents may be used as alternative choices. If the target BP level is not achieved during the Titration or Follow-up periods, adjustment of drug type and dosage will be carried out according to procedures defined in the protocol.

SBP <130 mmHg. For all participants, 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. For those who can't tolerate enalapril-folic acid well, other types of antihypertensive agents may be used as alternative choices. If the target BP level is not achieved during the Titration or Follow-up periods, adjustment of drug type and dosage will be carried out according to procedures defined in the protocol.

Outcomes

Primary Outcome Measures

Achieved mean blood pressure levels in each of the treatment groups

Secondary Outcome Measures

Carotid intima-media thickness (CIMT), Carotid plaques
Carotid-femoral pulse wave velocity, Brachial-ankle pulse wave velocity
Ankle brachial index
Urinary albumin-creatinine ratio

Full Information

First Posted
June 18, 2016
Last Updated
October 13, 2016
Sponsor
Second Affiliated Hospital of Nanchang University
Collaborators
Peking University First Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02817503
Brief Title
Feasibility Study of the Intensive Systolic Blood Pressure Control
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Second Affiliated Hospital of Nanchang University
Collaborators
Peking University First Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Hyperhomocysteinemia
Keywords
hypertension, BP titration, intensive blood pressure control, primary prevention, China, H-type Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard BP control
Arm Type
Experimental
Arm Description
SBP within 140 - <150 mmHg. For all participants, 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. For those who can't tolerate enalapril-folic acid well, other types of antihypertensive agents may be used as alternative choices. If the target BP level is not achieved during the Titration or Follow-up periods, adjustment of drug type and dosage will be carried out according to procedures defined in the protocol.
Arm Title
Moderate BP control
Arm Type
Active Comparator
Arm Description
SBP within 130 - <140 mmHg. For all participants, 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. For those who can't tolerate enalapril-folic acid well, other types of antihypertensive agents may be used as alternative choices. If the target BP level is not achieved during the Titration or Follow-up periods, adjustment of drug type and dosage will be carried out according to procedures defined in the protocol.
Arm Title
Intensive BP control
Arm Type
Active Comparator
Arm Description
SBP <130 mmHg. For all participants, 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. For those who can't tolerate enalapril-folic acid well, other types of antihypertensive agents may be used as alternative choices. If the target BP level is not achieved during the Titration or Follow-up periods, adjustment of drug type and dosage will be carried out according to procedures defined in the protocol.
Intervention Type
Drug
Intervention Name(s)
Standard BP control
Other Intervention Name(s)
Enalapril-folic acid,amlodipine,hydrochlorothiazide
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Moderate BP control
Other Intervention Name(s)
Enalapril-folic acid,amlodipine,hydrochlorothiazide
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Intensive BP control
Other Intervention Name(s)
Enalapril-folic acid,amlodipine,hydrochlorothiazide
Intervention Description
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.
Primary Outcome Measure Information:
Title
Achieved mean blood pressure levels in each of the treatment groups
Time Frame
6 months BP titration treatment period
Secondary Outcome Measure Information:
Title
Carotid intima-media thickness (CIMT), Carotid plaques
Time Frame
6 months BP titration treatment period
Title
Carotid-femoral pulse wave velocity, Brachial-ankle pulse wave velocity
Time Frame
6 months BP titration treatment period
Title
Ankle brachial index
Time Frame
6 months BP titration treatment period
Title
Urinary albumin-creatinine ratio
Time Frame
6 months BP titration treatment period
Other Pre-specified Outcome Measures:
Title
Events related to the intensive blood pressure control, Hypotension, Syncope, Bradycardia or Arrhythmia, Hyperkalemia, Renal Failure
Time Frame
6 months BP titration treatment period
Title
First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death hospitalization; Hospitalization
Description
6 months BP titration treatment period
Time Frame
during the Randomization and Titration Treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoshu Cheng, MD
Organizational Affiliation
Second Affiliated Hospital of Nanchang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
the People's Hospital of Rongcheng
City
Rongcheng
State/Province
Shandong
ZIP/Postal Code
264300
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25771069
Citation
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.
Results Reference
background
PubMed Identifier
32527283
Citation
Huang X, Liu L, Song Y, Gao L, Zhao M, Bao H, Qin X, Wu Y, Wu Q, Bi C, Yue A, Fang C, Ma H, Cui Y, Tang G, Li P, Zhang Y, Li J, Wang B, Xu X, Wang H, Parati G, Spence JD, Wang X, Huo Y, Chen G, Cheng X; investigators of intensive BP control in China. Achieving blood pressure control targets in hypertensive patients of rural China - a pilot randomized trial. Trials. 2020 Jun 11;21(1):515. doi: 10.1186/s13063-020-04368-1.
Results Reference
derived

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Feasibility Study of the Intensive Systolic Blood Pressure Control

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