The Diagnosis and Treatment of Resistant Hypertension, the Prevalence and the Prognosis (doublepres)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Cardiovascular Institute & Fuwai Hospital
Sponsor:
Collaborators:
Huazhong University of Science and Technology
Shanghai Jiao Tong University School of Medicine
Information provided by (Responsible Party):
hui rutai, Cardiovascular Institute & Fuwai Hospital
ClinicalTrials.gov Identifier:
NCT01703780
First received: October 7, 2012
Last updated: October 23, 2012
Last verified: October 2012
  Purpose

Hypertension is still one of the major preventable risk factor for cardiovascular as well as cerebrovascular diseases globally, including ischaemic heart disease, heart failure, and renal impairment. Despite knowledge on hypertension and the availability of effective antihypertensive medications have progressed dramatically in recent years, the rate of uncontrolled hypertension ( reached 90%) remains high in China(1). Among those with uncontrolled hypertension,it has been reported that 8.9% in all individuals with hypertension, and 12.8% in the hypertensive drug-treated population[2] are attributed to resistant hypertension. Resistant hypertension has been defined by AHA as high blood pressure (BP) in spite of appropriate lifestyle interventions and treatment of three or more different types of antihypertensive drugs at optimal dose, including at least one diuretics[3,4] or achieving adequate BP control with optimal doses of 4 or more antihypertensive drugs.

At present, not many specifically designed prospective researches concerning resistant hypertension are available. The prevalence of resistant hypertension is not well established and most knowledge about resistant hypertension derives from cross-sectional analyses and clinical trials. The patients with resistant hypertension have been expected to have server target damage, and worse prognosis than those who are non-resistant, but not well established either in the literature[2].

The purpose of this study is to determine the prevalence and the prognosis of resistant hypertension ascertained with systemic investigation and optimal treatment with antihypertensive drugs in community populations and clinic as well as the prognosis among patients with resistant hypertension compared with those who are non-resistant.


Condition
Hypertension, Resistant to Conventional Therapy

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The Prevalence and the Prognosis of Resistant Hypertension Ascertained With Systemic Investigation and Optimal Treatment With Antihypertensive Drugs

Resource links provided by NLM:


Further study details as provided by Cardiovascular Institute & Fuwai Hospital:

Primary Outcome Measures:
  • acute coronary syndrome [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    unstable angina,fatal and non-fatal myocardial infarction


Secondary Outcome Measures:
  • stroke [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    ischemic stroke, hemorrhage stroke


Other Outcome Measures:
  • All cause death [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Cardiovascular death [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

whole blood, serum, white cells, urine


Estimated Enrollment: 10000
Study Start Date: July 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
resistant hypertension
blood pressure remaining above goal (< 140/90 mm Hg for the general population and < 130/80 mm Hg for patients with diabetes or renal disease) despite using optimal doses of 3 antihypertensive agents of different classes(including a diuretic) for half to one year.
controllable hypertension
blood pressure can reach 130/80 mm Hg or less in half year by use of optimal dose of less than 3 antihypertensive agents of different classes
healthy control
  1. Age>50 years old
  2. Blood pressure ≤ 120/80 mm Hg( 24-hour blood pressure monitor or home blood pressure measurement at 6-9 am and 5-8pm, twice)
  3. No cardiovascular diseases: coronary artery disease(coronary angiography or CTA), cerebrovascular diseases(history, MRI-Lacunar brain stem), Carotid ultrasound
  4. No peripheral angiopathy (ABI<0.9 or lower extremity vessels Doppler ultrasound)
  5. No major cardiovascular risk factors:

    1. Dyslipidemia
    2. Diabetes
    3. Smoke within one year

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

50% hypertensive patients from community population, 50% hypertensive patients from clinic as consecutive patients

Criteria

Inclusion Criteria:

Resistant hypertension,ascertained according to AHA criteria: blood pressure remaining above goal (< 140/90 mm Hg for the general population and < 130/80 mm Hg for patients with diabetes or renal disease) despite using optimal doses of 3 antihypertensive agents of different classes(including a diuretic) for half to one year.

controllable hypertension blood pressure can reach 130/80 mm Hg or less in half year by use of optimal dose of less than 3 antihypertensive agents of different classes

healthy control

  • Age>50 years old
  • Blood pressure ≤ 120/80 mm Hg( 24-hour blood pressure monitor or home blood pressure measurement at 6-9 am and 5-8pm, twice)
  • No cardiovascular diseases: coronary artery disease(coronary angiography or CTA), cerebrovascular diseases(history, MRI-Lacunar brain stem), Carotid ultrasound
  • No peripheral angiopathy (ABI<0.9 or lower extremity vessels Doppler ultrasound)
  • No major cardiovascular risk factors: Dyslipidemia, Diabetes,Smoking within one year.

Exclusion Criteria:

  • severe hepatic diseases
  • mental diseases
  • cancer
  • systemic diseases
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01703780

Contacts
Contact: Rutai Hui, Doctor 86-010-88398154 huirutai@gmail.com

Locations
China, Beijing
FuWai Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College Recruiting
Beijing, Beijing, China, 100037
Contact: Rutai Hui, Doctor    +86-10-88398154    huirutai@gmail.com   
Principal Investigator: Rutai Hui, Doctor         
Principal Investigator: Xianliang Zhou         
The general hospital of Chinese People's Liberation Army Not yet recruiting
Beijing, Beijing, China, 100853
Principal Investigator: Yufeng Li         
Xuanwu Hospital, Capital Medical University Not yet recruiting
Beijing, Beijing, China, 100053
Principal Investigator: Qi Hua         
China, Fujian
The First Affiliated Hospital of Fujian Medical University Not yet recruiting
Fuzhou, Fujian, China, 350005
Principal Investigator: Liangdi Xie         
China, Guangdong
Nanfang Hospital of southern medical university Not yet recruiting
Guangzhou, Guangdong, China, 510515
Principal Investigator: Dingli Xu         
China, Heilongjiang
Hongxinglong Center Hospital Recruiting
Shuangyashan, Heilongjiang, China, 155811
Contact: Dianjun Gong       hxlkjk@163.com   
Principal Investigator: Dianjun Gong         
Principal Investigator: Dianwen Wang         
China, Henan
Henan Provincial People's Hospital Not yet recruiting
Zhengzhou, Henan, China, 450000
Principal Investigator: Hao Wang         
China, Hubei
TongJi Hospital, TongJi Medical Colleage, HuaZhong University of Science and Technology Not yet recruiting
Wu Han, Hubei, China, 430000
Principal Investigator: Daowen Wang         
China, Jiangsu
The Third People's Hospital of Xuzhou Not yet recruiting
Xuzhou, Jiangsu, China, 221005
Principal Investigator: Lanying Wang         
Principal Investigator: Shuhong Ren         
China, Jilin
The First Bethun Hospital of Jilin University Not yet recruiting
Changchun, Jilin, China, 130012
Principal Investigator: Yang Zheng         
China, Shandong
Affiliated Hospital of Jining Medical University Not yet recruiting
Jining, Shandong, China, 272000
Principal Investigator: Qingxian Li         
Qingdao Municipal Hospital Not yet recruiting
QingDao, Shandong, China, 266300
Principal Investigator: Xu Wang         
Rizhao Port Hospital Recruiting
Rizhao, Shandong, China, 276826
Contact: Jun Zheng       rzgkyy@163.com   
Principal Investigator: Jun Zheng         
China, Shanghai
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Not yet recruiting
Shanghai, Shanghai, China, 200025
Principal Investigator: Yan Li         
China, Shanxi
First Hospital of Shanxi Medical University Not yet recruiting
TaiYuan, Shanxi, China, 030001
Principal Investigator: Chuanshi Xiao         
The fourth military medical university Not yet recruiting
Xi'an, Shanxi, China
Principal Investigator: Lianyou Zhao         
China, Sichuan
West China Hospital,Sichuan Univer Not yet recruiting
ChengDu, Sichuan, China, 610041
Principal Investigator: Xiaoping Chen         
China, Tianjin
Tianjin Chest Hospital Not yet recruiting
Tianjin, Tianjin, China, 300051
Principal Investigator: Qin Qin         
Sponsors and Collaborators
Cardiovascular Institute & Fuwai Hospital
Huazhong University of Science and Technology
Shanghai Jiao Tong University School of Medicine
Investigators
Principal Investigator: Rutai Hui, MD & PhD Cardiovascular Institute and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical college
  More Information

Publications:

Responsible Party: hui rutai, Director, Cardiovascular Institute & Fuwai Hospital
ClinicalTrials.gov Identifier: NCT01703780     History of Changes
Other Study ID Numbers: 2011BAI11B04
Study First Received: October 7, 2012
Last Updated: October 23, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Coronary Vasospasm
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Myocardial Ischemia
Heart Diseases
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014