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Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients (STEP)

Primary Purpose

Primary Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intensive BP control
Standard BP control
Sponsored by
Chinese Academy of Medical Sciences, Fuwai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Hypertension focused on measuring Blood pressure control

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Systolic BP between 140-190 mm Hg in the three screening visits or currently under anti-hypertension treatment；
  2. An age of 60 - 80 years old；
  3. Signed the written informed consent.

Exclusion Criteria:

  1. Systolic BP≥190 mm Hg, or diastolic BP <60 mm Hg;
  2. Known secondary cause of hypertension;
  3. History of large atherosclerotic cerebral infarction or hemorrhagic stroke (not lacunar infarction and transient ischemic attack [TIA]);
  4. Hospitalization for myocardial infarction or unstable angina within the previous 6 months;
  5. Coronary revascularization (PCI or CABG) within the previous 12 months;
  6. Planned to perform coronary revascularization (PCI or CABG) in the future 12 months;
  7. History of sustained atrial fibrillation or Ventricular arrhythmias at entry influencing the measurement of electronic blood pressure；
  8. NYHA class III-IV heart failure at entry or hospitalization for exacerbation of chronic heart failure within the previous 6 months;
  9. Severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the trial;
  10. Dilated or hypertrophic cardiomyopathy, rheumatic heart disease, or congenital heart disease;
  11. Uncontrolled diabetes (serum fasting glucose ≥200 mg/dl [11.1 mmol/L], HbA1>8%);
  12. Lab tests indicating abnormal liver or kidney function (ALT more than 3 times the upper limit of normal value, or end stage renal disease (ESRD) on dialysis, or estimated glomerular filtration rate (eGFR) <30 mL/min, or serum creatine >2.5 mg/dl [>221 umol/L];
  13. Severe somatic disease such as cancer;
  14. Severe cognitive impairment or mental disorders;
  15. Participating in other clinical trials.

Sites / Locations

  • Beijing Chaoyang Hospital affiliated to Capical Medical University
  • Bei Jing Hospital
  • Chinese Academy of Medical Sciences, FuWai Hospital
  • Xuanwu hospital of capital medical university
  • Peking Union Medical College Hospital
  • Beijing Pinggu Hospital
  • Lanzhou University Second Hospital
  • Guangdong Cardiovascular Institute
  • Huizhou Municipal Central Hospital
  • The Second Affiliated Hospital to Medical College Shantou University Guangdong
  • Shenzhen Sun Yat-sen Cardiovascular Hospital
  • The First Affiliated Hospital of Guangxi Medical University
  • The First Affiliated Hospital of Guangxi University of Chinese Medicine
  • Kailua General Hospital
  • The First Affiliated Hospital of Hebei North University
  • First affiliated Hospital of Harbin Medical University
  • Hong xinglong center hospital
  • First Affiliated Hospitalof Zhengzhou University
  • Zhoukou City Central Hospital
  • Renmin Hospital of Wuhan University
  • Kang Ya Hospita
  • The Second Affiliated Hospital of Baotou Medical College
  • Zhenjiang First People's Hospital
  • the Second Affiliated Hospitalof NanChang University
  • Benxi Railway Hospital
  • The 1st Affiliated Hospital of Dalian Medical University
  • The First People's Hospital of Yinchuan
  • Qilu Hospital of Shandong University
  • Jining First People's Hospital
  • Shanghai general hospital, Shanghai Jiaotong University
  • First Hospital of Shanxi Medical University
  • Shanxi caidiovascular hospital
  • Shanxi Academy of Medical Sciences, Shanxi Dayi Hospital
  • First Affiliated Hospital, Xian Jiaotong University
  • West China Hospital, Sichuan University
  • College of Medicine , National Taiwan University
  • Pingjin Hospital, Logistics University of PAPF
  • the People's Hospital of Ji Xian Distric
  • First Affiliated Hospital of Xinjiang Medical University
  • Yan'an Hospital affiliated to kunming medical university, Yunnan Cardiovascular Hospital
  • The Second Affiliated Hospital of Kunming Medical University
  • The First Hospital of Kunming

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intensive BP control

Standard BP control

Arm Description

SBP within 110 - <130 mm Hg. Participants randomized into the Intensive BP control arm will have a goal of SBP 110 - <130 mm Hg.

SBP within 130 - <150 mm Hg. Participants randomized into the Intensive BP control arm will have a goal of SBP 130 - <150 mm Hg.

Outcomes

Primary Outcome Measures

Primary composite outcome
A composite end-point comprised of acute coronary syndrome (myocardial infarction and hospitalization for unstable angina), first occurrence of symptomatic stroke ( ischemic or hemorrhagic stroke), hospitalization for decompensated heart failure, coronary revascularization (percutaneous coronary intervention [PCI], coronary artery bypass grafting [CABG]), atrial fibrillation, and death from cardiovascular causes.

Secondary Outcome Measures

Composite of major adverse cardiac events (primary outcome without stroke)
Composite of major adverse cardiac events comprised of acute coronary syndrome (myocardial infarction and hospitalization for unstable angina), hospitalization for decompensated heart failure, coronary revascularization (percutaneous coronary intervention [PCI], coronary artery bypass grafting [CABG]), atrial fibrillation, and death from cardiovascular causes.
First occurrence of symptomatic stroke ( ischemic or hemorrhagic)
Stroke is defined as a rapid onset of focal (or global) disturbance of cerebral function lasting more than 24 hours (except interrupted by surgery or death) without resolution of symptoms according to the World Health Organization. The diagnosis of stroke is confirmed by strict neurological examination, computed tomography (CT), or magnetic resonance imaging (MRI), and stroke subtypes are classified including ischemic or hemorrhagic, fatal or not fatal.
Acute coronary syndrome
Acute coronary syndrome includes myocardial infarction and hospitalization for unstable angina. The diagnosis of MI is based on the following criteria: (1) Patient has cardiac signs and symptoms, such as retrosternal pain last for at least 30 minutes, and not relieve to nitroglycerine during the attack; (2) Electrocardiographic abnormal findings of MI are observed; (3) Biochemical markers of cardiac damage are present. The diagnosis of unstable angina requires hospitalization for evaluation. The clinical presentation of unstable angina includes: (1) prolonged (>20 min) angina pain at rest; (2) new onset angina; (3) post-MI angina; (4) recent destabilization of previously stable angina with at least Canadian Cardiovascular Society Class III angina characteristics.
Hospitalization for acute decompensated heart failure
Diagnosis of acute decompensated heart failure requires a hospitalization or emergency department visit which provides an infusion therapy for clinical signs and symptoms consistent with cardiac decompensation or inadequate cardiac pump function, such as increasing or new onset shortness of breath, peripheral edema, paroxysmal dyspnea, orthopnea, or hypoxia.
coronary revascularization (percutaneous coronary intervention [PCI], coronary artery bypass grafting [CABG])
Patients are treated with coronary revascularization by either PCI or CABG due to acute coronary syndromes (ACS) and stable ischemic heart disease (SIHD).
Atrial fibrillation
Diagnosis of AF requires rhythm evidence of an ECG showing the typical pattern including absolutely irregular RR intervals and no discernible, distinct P waves.
Cardiovascular death
Cardiovascular death includes fatal coronary heart disease, fatal stroke, death from heart failure, and sudden cardiac death.
All-cause death
All-cause death includes death due to any reasons during the trial. Evidence for death includes death certificates from hospitals or reports of home visit from investigators.
First occurrence of diabetes mellitus
Diagnosis of incident diabetes mellitus includes the following criteria: (1) Fasting plasma glucose ≥ 126 mg/dl (≥ 7.0 mmol/dl); or (2) Oral glucose tolerance test 2-hour glucose in venous plasma ≥ 200 mg/dl (≥ 11.1 mmol/l); or (3) In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥ 200 mg/dl (≥ 11.1 mmol/l); or (4) Glycosylated hemoglobin (HbA1c) ≥ 6.5% (48 mmol/mol).
Decline in cognitive function
Decline in cognitive function includes sensory disturbance, memory disorders and thinking disorders, which is assessed by mini-mental state examination (MMSE)
Decline in renal function or development of end stage renal disease (ESRD)
Decline in renal function is assessed by any of the following: (1) For patients with chronic kidney disease (eGFR <60 ml per minute per 1.73 m2) at baseline, the renal outcome was a composite of a decrease in the eGFR of 50% or more (confirmed by a subsequent laboratory test) or the development of ESRD requiring long-term dialysis or kidney transplantation; or (2) For participants without chronic kidney disease at baseline, the renal outcome was defined by a decrease in the eGFR of 30% or more to a value of less than 60 ml per minute per 1.73 m2.
Major artery stiffness
Major artery stiffness are assessed by a composite of decrease in the ankle brachial index [ABI], brachial-ankle pulse wave velocity(baPWV), or brachial artery flow-mediated dilation [FMD]. ABI and baPWV,well-established non-invasive techniques for evaluating obstruction and stiffness of peripheral artery respectively, are considered for the purposes of cardiovascular risk assessment. ABI is the ratio of the average systolic blood pressure measured in brachial/ankle, and an ABI between and including 0.9 and 1.2 is considered normal, while a lesser than 0.9 indicates arterial disease. The unit measure of baPWV value is cm per second. FMD serves as an index of nitric oxide (NO)-mediated endothelium-dependent vasodilator function in humans and is regarded as a surrogate marker of cardiovascular disease.

Full Information

First Posted
January 2, 2017
Last Updated
July 22, 2021
Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03015311
Brief Title
Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients
Acronym
STEP
Official Title
Strategy of Systolic Blood Pressure Intervention in the Elderly Hypertensive Patients: A Prospective Randomized Open-Label Blinded-Endpoint Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2017 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients (STEP) is a 2-arm, multi-center, prospective, randomized, open-labeled, blinded-endpoint trial. The purpose of this trial is to test whether a treatment program aimed at reducing systolic blood pressure (SBP) to a lower goal (<130 mmHg, intensive treatment) than currently recommended (<150 mmHg, standard treatment) will reduce CVD risk among persons between 60-80 years of old. Furthermore, this trial will also examine the effect of blood pressure APP management strategy via WeChat network on medication compliance, blood pressure control and CVD benefits.
Detailed Description
Hypertension is highly prevalent in the adult population in China, and its burden is rapidly increasing among persons older than 60 years of age. Elevated blood pressure (BP) is an important public health concern which contributes to several adverse health outcomes, especially coronary heart disease, stroke, heart failure, chronic kidney disease, and decline in cognitive function. Clinical trials have shown that a lower systolic blood pressure goal will lead to greater reduction in cardiovascular disease (CVD) incidence, but the effect of intensive treatment of systolic blood pressure below 120 mm Hg in reducing of CVD risk has long been debated. In particularly, among the elderly hypertensive patients aged 60 years or older, the most appropriate targets for blood pressure lowering to reduce cardiovascular events still remain uncertain. The STEP trial will randomize about 8000 participants aged between 60 and 80 years with SBP≥140 mm Hg and <190 mm Hg, and without a history of atherothrombotic or hemorrhagic stroke. Target SBP goals are 110-130 vs 130-150 mm Hg, respectively. The purpose of the STEP trial is to test whether a treatment program aimed at reducing systolic blood pressure (SBP) to a lower goal (<130 mmHg, intensive treatment) than currently recommended (<150 mmHg, standard treatment) will reduce CVD risk among hypertensive patients between 60-80 years. Participants will be recruited at approximately 40 clinic centers in China within approximately a 1-year period, and will be followed for 4 years. Furthermore, this trial will also examine the effect of blood pressure APP management strategy via WeChat network on medication compliance, blood pressure control and CVD benefits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hypertension
Keywords
Blood pressure control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
8000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intensive BP control
Arm Type
Experimental
Arm Description
SBP within 110 - <130 mm Hg. Participants randomized into the Intensive BP control arm will have a goal of SBP 110 - <130 mm Hg.
Arm Title
Standard BP control
Arm Type
Active Comparator
Arm Description
SBP within 130 - <150 mm Hg. Participants randomized into the Intensive BP control arm will have a goal of SBP 130 - <150 mm Hg.
Intervention Type
Drug
Intervention Name(s)
Intensive BP control
Other Intervention Name(s)
Lower target for reducing SBP
Intervention Description
For all participants, Olmesartan Medoxomil tablets or Amlodipine Besylate tablets will be used as an initial therapy. Other drugs, including hydrochlorothiazide and β-blockers, are allowed, in order to achieve the SBP target. If the target BP level is not achieved during the 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)
Standard target for reducing SBP
Intervention Description
For all participants, Olmesartan Medoxomil tablets or Amlodipine Besylate tablets will be used as an initial therapy. Other drugs, including hydrochlorothiazide and β-blockers, are allowed, in order to achieve the SBP target. If the target BP level is not achieved during the Follow-up periods, adjustment of drug type and dosage will be carried out according to procedures defined in the protocol.
Primary Outcome Measure Information:
Title
Primary composite outcome
Description
A composite end-point comprised of acute coronary syndrome (myocardial infarction and hospitalization for unstable angina), first occurrence of symptomatic stroke ( ischemic or hemorrhagic stroke), hospitalization for decompensated heart failure, coronary revascularization (percutaneous coronary intervention [PCI], coronary artery bypass grafting [CABG]), atrial fibrillation, and death from cardiovascular causes.
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Composite of major adverse cardiac events (primary outcome without stroke)
Description
Composite of major adverse cardiac events comprised of acute coronary syndrome (myocardial infarction and hospitalization for unstable angina), hospitalization for decompensated heart failure, coronary revascularization (percutaneous coronary intervention [PCI], coronary artery bypass grafting [CABG]), atrial fibrillation, and death from cardiovascular causes.
Time Frame
4 years
Title
First occurrence of symptomatic stroke ( ischemic or hemorrhagic)
Description
Stroke is defined as a rapid onset of focal (or global) disturbance of cerebral function lasting more than 24 hours (except interrupted by surgery or death) without resolution of symptoms according to the World Health Organization. The diagnosis of stroke is confirmed by strict neurological examination, computed tomography (CT), or magnetic resonance imaging (MRI), and stroke subtypes are classified including ischemic or hemorrhagic, fatal or not fatal.
Time Frame
4 years
Title
Acute coronary syndrome
Description
Acute coronary syndrome includes myocardial infarction and hospitalization for unstable angina. The diagnosis of MI is based on the following criteria: (1) Patient has cardiac signs and symptoms, such as retrosternal pain last for at least 30 minutes, and not relieve to nitroglycerine during the attack; (2) Electrocardiographic abnormal findings of MI are observed; (3) Biochemical markers of cardiac damage are present. The diagnosis of unstable angina requires hospitalization for evaluation. The clinical presentation of unstable angina includes: (1) prolonged (>20 min) angina pain at rest; (2) new onset angina; (3) post-MI angina; (4) recent destabilization of previously stable angina with at least Canadian Cardiovascular Society Class III angina characteristics.
Time Frame
4 years
Title
Hospitalization for acute decompensated heart failure
Description
Diagnosis of acute decompensated heart failure requires a hospitalization or emergency department visit which provides an infusion therapy for clinical signs and symptoms consistent with cardiac decompensation or inadequate cardiac pump function, such as increasing or new onset shortness of breath, peripheral edema, paroxysmal dyspnea, orthopnea, or hypoxia.
Time Frame
4 years
Title
coronary revascularization (percutaneous coronary intervention [PCI], coronary artery bypass grafting [CABG])
Description
Patients are treated with coronary revascularization by either PCI or CABG due to acute coronary syndromes (ACS) and stable ischemic heart disease (SIHD).
Time Frame
4 years
Title
Atrial fibrillation
Description
Diagnosis of AF requires rhythm evidence of an ECG showing the typical pattern including absolutely irregular RR intervals and no discernible, distinct P waves.
Time Frame
4 years
Title
Cardiovascular death
Description
Cardiovascular death includes fatal coronary heart disease, fatal stroke, death from heart failure, and sudden cardiac death.
Time Frame
4 years
Title
All-cause death
Description
All-cause death includes death due to any reasons during the trial. Evidence for death includes death certificates from hospitals or reports of home visit from investigators.
Time Frame
4 years
Title
First occurrence of diabetes mellitus
Description
Diagnosis of incident diabetes mellitus includes the following criteria: (1) Fasting plasma glucose ≥ 126 mg/dl (≥ 7.0 mmol/dl); or (2) Oral glucose tolerance test 2-hour glucose in venous plasma ≥ 200 mg/dl (≥ 11.1 mmol/l); or (3) In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥ 200 mg/dl (≥ 11.1 mmol/l); or (4) Glycosylated hemoglobin (HbA1c) ≥ 6.5% (48 mmol/mol).
Time Frame
4 years
Title
Decline in cognitive function
Description
Decline in cognitive function includes sensory disturbance, memory disorders and thinking disorders, which is assessed by mini-mental state examination (MMSE)
Time Frame
4 years
Title
Decline in renal function or development of end stage renal disease (ESRD)
Description
Decline in renal function is assessed by any of the following: (1) For patients with chronic kidney disease (eGFR <60 ml per minute per 1.73 m2) at baseline, the renal outcome was a composite of a decrease in the eGFR of 50% or more (confirmed by a subsequent laboratory test) or the development of ESRD requiring long-term dialysis or kidney transplantation; or (2) For participants without chronic kidney disease at baseline, the renal outcome was defined by a decrease in the eGFR of 30% or more to a value of less than 60 ml per minute per 1.73 m2.
Time Frame
4 years
Title
Major artery stiffness
Description
Major artery stiffness are assessed by a composite of decrease in the ankle brachial index [ABI], brachial-ankle pulse wave velocity(baPWV), or brachial artery flow-mediated dilation [FMD]. ABI and baPWV,well-established non-invasive techniques for evaluating obstruction and stiffness of peripheral artery respectively, are considered for the purposes of cardiovascular risk assessment. ABI is the ratio of the average systolic blood pressure measured in brachial/ankle, and an ABI between and including 0.9 and 1.2 is considered normal, while a lesser than 0.9 indicates arterial disease. The unit measure of baPWV value is cm per second. FMD serves as an index of nitric oxide (NO)-mediated endothelium-dependent vasodilator function in humans and is regarded as a surrogate marker of cardiovascular disease.
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Systolic BP between 140-190 mm Hg in the three screening visits or currently under anti-hypertension treatment； An age of 60 - 80 years old； Signed the written informed consent. Exclusion Criteria: Systolic BP≥190 mm Hg, or diastolic BP <60 mm Hg; Known secondary cause of hypertension; History of large atherosclerotic cerebral infarction or hemorrhagic stroke (not lacunar infarction and transient ischemic attack [TIA]); Hospitalization for myocardial infarction or unstable angina within the previous 6 months; Coronary revascularization (PCI or CABG) within the previous 12 months; Planned to perform coronary revascularization (PCI or CABG) in the future 12 months; History of sustained atrial fibrillation or Ventricular arrhythmias at entry influencing the measurement of electronic blood pressure； NYHA class III-IV heart failure at entry or hospitalization for exacerbation of chronic heart failure within the previous 6 months; Severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the trial; Dilated or hypertrophic cardiomyopathy, rheumatic heart disease, or congenital heart disease; Uncontrolled diabetes (serum fasting glucose ≥200 mg/dl [11.1 mmol/L], HbA1>8%); Lab tests indicating abnormal liver or kidney function (ALT more than 3 times the upper limit of normal value, or end stage renal disease (ESRD) on dialysis, or estimated glomerular filtration rate (eGFR) <30 mL/min, or serum creatine >2.5 mg/dl [>221 umol/L]; Severe somatic disease such as cancer; Severe cognitive impairment or mental disorders; Participating in other clinical trials.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Cai, MD
Organizational Affiliation
Chinese Academy of Medical Sciences, Fuwai Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Chaoyang Hospital affiliated to Capical Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Facility Name
Bei Jing Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100037
Country
China
Facility Name
Chinese Academy of Medical Sciences, FuWai Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100037
Country
China
Facility Name
Xuanwu hospital of capital medical university
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Beijing Pinggu Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Lanzhou University Second Hospital
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730030
Country
China
Facility Name
Guangdong Cardiovascular Institute
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Huizhou Municipal Central Hospital
City
Huizhou
State/Province
Guangdong
ZIP/Postal Code
516001
Country
China
Facility Name
The Second Affiliated Hospital to Medical College Shantou University Guangdong
City
Shantou
State/Province
Guangdong
ZIP/Postal Code
515041
Country
China
Facility Name
Shenzhen Sun Yat-sen Cardiovascular Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518001
Country
China
Facility Name
The First Affiliated Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Facility Name
The First Affiliated Hospital of Guangxi University of Chinese Medicine
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530023
Country
China
Facility Name
Kailua General Hospital
City
Tangshan
State/Province
Hebei
ZIP/Postal Code
063000
Country
China
Facility Name
The First Affiliated Hospital of Hebei North University
City
Zhangjiakou
State/Province
Hebei
ZIP/Postal Code
075000
Country
China
Facility Name
First affiliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150001
Country
China
Facility Name
Hong xinglong center hospital
City
Shuangyashan
State/Province
Heilongjiang
Country
China
Facility Name
First Affiliated Hospitalof Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Facility Name
Zhoukou City Central Hospital
City
Zhoukou
State/Province
Henan
ZIP/Postal Code
466000
Country
China
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Facility Name
Kang Ya Hospita
City
Yiyang
State/Province
Hunan
ZIP/Postal Code
413000
Country
China
Facility Name
The Second Affiliated Hospital of Baotou Medical College
City
Baotou
State/Province
Inner Mongolia
ZIP/Postal Code
014030
Country
China
Facility Name
Zhenjiang First People's Hospital
City
Zhenjiang
State/Province
Jiangsu
ZIP/Postal Code
212002
Country
China
Facility Name
the Second Affiliated Hospitalof NanChang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
Benxi Railway Hospital
City
Benxi
State/Province
Liaoning
ZIP/Postal Code
117000
Country
China
Facility Name
The 1st Affiliated Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
Country
China
Facility Name
The First People's Hospital of Yinchuan
City
Yinchuan
State/Province
Ningxia
Country
China
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Facility Name
Jining First People's Hospital
City
Jining
State/Province
Shandong
ZIP/Postal Code
272011
Country
China
Facility Name
Shanghai general hospital, Shanghai Jiaotong University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200080
Country
China
Facility Name
First Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030001
Country
China
Facility Name
Shanxi caidiovascular hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030024
Country
China
Facility Name
Shanxi Academy of Medical Sciences, Shanxi Dayi Hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030032
Country
China
Facility Name
First Affiliated Hospital, Xian Jiaotong University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
College of Medicine , National Taiwan University
City
Taibei
State/Province
Taiwan
Country
China
Facility Name
Pingjin Hospital, Logistics University of PAPF
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300162
Country
China
Facility Name
the People's Hospital of Ji Xian Distric
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
First Affiliated Hospital of Xinjiang Medical University
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830054
Country
China
Facility Name
Yan'an Hospital affiliated to kunming medical university, Yunnan Cardiovascular Hospital
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650051
Country
China
Facility Name
The Second Affiliated Hospital of Kunming Medical University
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650101
Country
China
Facility Name
The First Hospital of Kunming
City
Kunming
State/Province
Yunnan
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Within 3 years after the trial complete
IPD Sharing Time Frame
Within 3 years after the trial complete
IPD Sharing Access Criteria
To share IPD in the magazine of paper published
Citations:
PubMed Identifier
26603746
Citation
Wang Y, Peng X, Nie X, Chen L, Weldon R, Zhang W, Xiao D, Cai J. Burden of hypertension in China over the past decades: Systematic analysis of prevalence, treatment and control of hypertension. Eur J Prev Cardiol. 2016 May;23(8):792-800. doi: 10.1177/2047487315617105. Epub 2015 Nov 24.
Results Reference
background
PubMed Identifier
26551272
Citation
SPRINT Research Group; Wright JT Jr, Williamson JD, Whelton PK, Snyder JK, Sink KM, Rocco MV, Reboussin DM, Rahman M, Oparil S, Lewis CE, Kimmel PL, Johnson KC, Goff DC Jr, Fine LJ, Cutler JA, Cushman WC, Cheung AK, Ambrosius WT. A Randomized Trial of Intensive versus Standard Blood-Pressure Control. N Engl J Med. 2015 Nov 26;373(22):2103-16. doi: 10.1056/NEJMoa1511939. Epub 2015 Nov 9. Erratum In: N Engl J Med. 2017 Dec 21;377(25):2506.
Results Reference
background
PubMed Identifier
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Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients

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