Clinical trial NCT03015311: Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients
Official title: Strategy of Systolic Blood Pressure Intervention in the Elderly Hypertensive Patients: A Prospective Randomized Open-Label Blinded-Endpoint Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Hypertension
Keywords: Blood pressure control
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2017-01-10
Enrollment: 8000
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary composite outcome
timeFrame: 4 years
Secondary outcomes:
measure: Composite of major adverse cardiac events (primary outcome without stroke)
timeFrame: 4 years
measure: First occurrence of symptomatic stroke ( ischemic or hemorrhagic)
timeFrame: 4 years
measure: Acute coronary syndrome
timeFrame: 4 years
measure: Hospitalization for acute decompensated heart failure
timeFrame: 4 years
measure: coronary revascularization (percutaneous coronary intervention [PCI], coronary artery bypass grafting [CABG])
timeFrame: 4 years
measure: Atrial fibrillation
timeFrame: 4 years
measure: Cardiovascular death
timeFrame: 4 years
measure: All-cause death
timeFrame: 4 years
measure: First occurrence of diabetes mellitus
timeFrame: 4 years
measure: Decline in cognitive function
timeFrame: 4 years
measure: Decline in renal function or development of end stage renal disease (ESRD)
timeFrame: 4 years
measure: Major artery stiffness
timeFrame: 4 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chaoyang Hospital affiliated to Capical Medical University
state: Beijing
city: Beijing
country: China
facility: Bei Jing Hospital
state: Beijing
city: Beijing
country: China
facility: Chinese Academy of Medical Sciences, FuWai Hospital
state: Beijing
city: Beijing
country: China
facility: Xuanwu hospital of capital medical university
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Pinggu Hospital
state: Beijing
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
state: Gansu
city: Guangzhou
country: China
facility: Guangdong Cardiovascular Institute
state: Guangdong
city: Huizhou
country: China
facility: Huizhou Municipal Central Hospital
state: Guangdong
city: Shantou
country: China
facility: The Second Affiliated Hospital to Medical College Shantou University Guangdong
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Sun Yat-sen Cardiovascular Hospital
state: Guangdong
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi University of Chinese Medicine
state: Guangxi
city: Tangshan
country: China
facility: Kailua General Hospital
state: Hebei
city: Zhangjiakou
country: China
facility: The First Affiliated Hospital of Hebei North University
state: Hebei
city: Harbin
country: China
facility: First affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Shuangyashan
country: China
facility: Hong xinglong center hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: First Affiliated Hospitalof Zhengzhou University
state: Henan
city: Zhoukou
country: China
facility: Zhoukou City Central Hospital
state: Henan
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Yiyang
country: China
facility: Kang Ya Hospita
state: Hunan
city: Baotou
country: China
facility: The Second Affiliated Hospital of Baotou Medical College
state: Inner Mongolia
city: Zhenjiang
country: China
facility: Zhenjiang First People's Hospital
state: Jiangsu
city: Nanchang
country: China
facility: the Second Affiliated Hospitalof NanChang University
state: Jiangxi
city: Benxi
country: China
facility: Benxi Railway Hospital
state: Liaoning
city: Dalian
country: China
facility: The 1st Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Yinchuan
country: China
facility: The First People's Hospital of Yinchuan
state: Ningxia
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Jining
country: China
facility: Jining First People's Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai general hospital, Shanghai Jiaotong University
state: Shanghai
city: Taiyuan
country: China
facility: First Hospital of Shanxi Medical University
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi caidiovascular hospital
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Academy of Medical Sciences, Shanxi Dayi Hospital
state: Shanxi
city: Xi'an
country: China
facility: First Affiliated Hospital, Xian Jiaotong University
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Taibei
country: China
facility: College of Medicine , National Taiwan University
state: Taiwan
city: Tianjin
country: China
facility: Pingjin Hospital, Logistics University of PAPF
state: Tianjin
city: Tianjin
country: China
facility: the People's Hospital of Ji Xian Distric
state: Tianjin
city: Urumqi
country: China
facility: First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Kunming
country: China
facility: Yan'an Hospital affiliated to kunming medical university, Yunnan Cardiovascular Hospital
state: Yunnan
city: Kunming
country: China
facility: The Second Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Kunming
country: China
facility: The First Hospital of Kunming
state: Yunnan
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Jun Cai, MD
role: STUDY_DIRECTOR
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