The Diagnosis and Treatment of Resistant Hypertension, the Prevalence and the Prognosis

NCT01703780 | Unknown

• 1 other identifier: 2011BAI11B04
• Study Type: observational
• Target: 9,638
• Locations: 1 country
• Sites: 18

Brief Summary

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 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.

Conditions

Hypertension, Resistant to Conventional Therapy

Outcome Measures

Primary Outcomes (1)

• Acute myocardial infarction

  3 years

Secondary Outcomes (1)

• Stroke

  3 years

Other Outcomes (2)

• All cause death

  3 years

• Cardiovascular death

  3 years

Study Arms (3)

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

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• severe hepatic diseases
• mental diseases
• cancer
• systemic diseases

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead
• Huazhong University of Science and Technology: collaborator
• Shanghai Jiao Tong University School of Medicine: collaborator

Study Sites (18)

FuWai Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College

Beijing, Beijing Municipality, 100037, China

Location

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

The general hospital of Chinese People's Liberation Army

Beijing, Beijing Municipality, 100853, China

Location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

Location

Nanfang Hospital of southern medical university

Guangzhou, Guangdong, 510515, China

Location

Hongxinglong Center Hospital

Shuangyashan, Heilongjiang, 155811, China

Location

Henan Provincial People's Hospital

Zhengzhou, Henan, 450000, China

Location

TongJi Hospital, TongJi Medical Colleage, HuaZhong University of Science and Technology

Wuhan, Hubei, 430000, China

Location

The Third People's Hospital of Xuzhou

Xuzhou, Jiangsu, 221005, China

Location

The First Bethun Hospital of Jilin University

Changchun, Jilin, 130012, China

Location

Affiliated Hospital of Jining Medical University

Jining, Shandong, 272000, China

Location

Qingdao Municipal Hospital

Qingdao, Shandong, 266300, China

Location

Rizhao Port Hospital

Rizhao, Shandong, 276826, China

Location

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

Location

The fourth military medical university

Xi’an, Shanxi, China

Location

West China Hospital，Sichuan Univer

Chengdu, Sichuan, 610041, China

Location

Tianjin Chest Hospital

Tianjin, Tianjin Municipality, 300051, China

Location

Related Publications (8)

• Gu D, Reynolds K, Wu X, Chen J, Duan X, Muntner P, Huang G, Reynolds RF, Su S, Whelton PK, He J; InterASIA Collaborative Group. The International Collaborative Study of Cardiovascular Disease in ASIA. Prevalence, awareness, treatment, and control of hypertension in china. Hypertension. 2002 Dec;40(6):920-7. doi: 10.1161/01.hyp.0000040263.94619.d5.

  PMID: 12468580 BACKGROUND

• Persell SD. Prevalence of resistant hypertension in the United States, 2003-2008. Hypertension. 2011 Jun;57(6):1076-80. doi: 10.1161/HYPERTENSIONAHA.111.170308. Epub 2011 Apr 18.

  PMID: 21502568 BACKGROUND

• Mansia G, De Backer G, Dominiczak A, Cifkova R, Fagard R, Germano G, Grassi G, Heagerty AM, Kjeldsen SE, Laurent S, Narkiewicz K, Ruilope L, Rynkiewicz A, Schmieder RE, Struijker Boudier HA, Zanchetti A; European Society of Hypertension; European Society of Cardiology. 2007 ESH-ESC Guidelines for the management of arterial hypertension: the task force for the management of arterial hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). Blood Press. 2007;16(3):135-232. doi: 10.1080/08037050701461084. No abstract available.

  PMID: 17846925 BACKGROUND

• Calhoun DA, Jones D, Textor S, Goff DC, Murphy TP, Toto RD, White A, Cushman WC, White W, Sica D, Ferdinand K, Giles TD, Falkner B, Carey RM; American Heart Association Professional Education Committee. Resistant hypertension: diagnosis, evaluation, and treatment: a scientific statement from the American Heart Association Professional Education Committee of the Council for High Blood Pressure Research. Circulation. 2008 Jun 24;117(25):e510-26. doi: 10.1161/CIRCULATIONAHA.108.189141.

  PMID: 18574054 BACKGROUND

• Brown MA, Buddle ML, Martin A. Is resistant hypertension really resistant? Am J Hypertens. 2001 Dec;14(12):1263-9. doi: 10.1016/s0895-7061(01)02193-8.

  PMID: 11775136 BACKGROUND

• Calhoun DA, Nishizaka MK, Zaman MA, Thakkar RB, Weissmann P. Hyperaldosteronism among black and white subjects with resistant hypertension. Hypertension. 2002 Dec;40(6):892-6. doi: 10.1161/01.hyp.0000040261.30455.b6.

  PMID: 12468575 BACKGROUND

• Vongpatanasin W. Resistant hypertension: a review of diagnosis and management. JAMA. 2014 Jun 4;311(21):2216-24. doi: 10.1001/jama.2014.5180.

  PMID: 24893089 BACKGROUND

• Zanger UM, Schwab M. Cytochrome P450 enzymes in drug metabolism: regulation of gene expression, enzyme activities, and impact of genetic variation. Pharmacol Ther. 2013 Apr;138(1):103-41. doi: 10.1016/j.pharmthera.2012.12.007. Epub 2013 Jan 16.

  PMID: 23333322 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, peripheral white blood cells, urine

MeSH Terms

Conditions

Hypertension Resistant to Conventional Therapy

Study Officials

• Rutai Hui, MD & PhD

  Cardiovascular Institute and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical college

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: October 7, 2012
• First Posted: October 11, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 27, 2016

Record last verified: 2016-04

Locations

CN (18)