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

Information source: Cardiovascular Institute & Fuwai Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension, Resistant to Conventional Therapy

Phase: N/A

Status: Recruiting

Sponsored by: Cardiovascular Institute & Fuwai Hospital

Official(s) and/or principal investigator(s):
Rutai Hui, MD & PhD, Principal Investigator, Affiliation: Cardiovascular Institute and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical college

Overall contact:
Rutai Hui, Doctor, Phone: 86-010-88398154, Email: huirutai@gmail.com

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 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.

Clinical Details

Official title: The Prevalence and the Prognosis of Resistant Hypertension Ascertained With Systemic Investigation and Optimal Treatment With Antihypertensive Drugs

Study design: Time Perspective: Prospective

Primary outcome: acute coronary syndrome

Secondary outcome: stroke

Detailed description: 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. Due to an increasing in incidence of comorbidities related to resistant hypertension such as diabetes, obesity and renal impairment, the prevalence of resistant-to-treatment hypertension is much more likely to increase in older population. The burden of resistant hypertension is going to be bigger and bigger. 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 the prognosis among patients with resistant hypertension compared with those who are non-resistant. Subjects:Total 10000 patients with hypertension are going to be recruited, 50% from 5 communities screening, 50% from consecutive clinic hypertensive patients. The Expected rate of resistant hypertension is 10% in hypertensive population. Objectives: 1. True prevalence of resistant hypertension In order to obtain the true burden of resistant hypertension, a uniform definition of resistant hypertension were applied, AHA definition(4), "high blood pressure (BP) remained 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 or achieving adequate BP control with optimal doses of 4 or more antihypertensive drugs. 1. To exclude pseudoresistant hypertension 2. To avoid inaccurate measurement of blood pressure 3. To make sure that both the patients and the physicians are adherent to therapeutic plans and to lifestyle interventions. The physicians comply with guidelines and actively pursue adequate blood pressure for their patients. Ninety per cent of the patients take recommended optimal daily doses of their antihypertensive medications at follow-up for 6 months as well as more than 85% for 2 years(less than 50% at present) Incidence of resistant hypertension TREATMENT RECOMMENDATIONS This is a practical clinical trial,no specific antihypertensive drugs are going to be tested in the trial. The antihypertensive drugs are selected according to guidelines. Treatment duration: six months of intensive treatment(optimal dose and type of drugs),blood pressure does not reach goal. The treatment of secondary causes of hypertension are referred to pertinent specialists. Appropriate lifestyle interventions are always encouraged: Nonpharmacological therapy: Reversal of lifestyle factors contributing to treatment resistance,

- DASH diet is encouraged to follow, lower salt diet (ideal goal< 100 mEq of

sodium/24 h,evaluated with 24h urine collection), low fat and high fibre diet,

- weight loss if obese or overweight,

- moderation of alcohol intake to no more than two drinks per day for men and

one drink for women or lighter-weight persons,

- smoking cessation,

- regular physical activity.

Optimal pharmacological therapy Drug treatment of resistant hypertension:

- Diuretics: Usually taking thiazide, among patients with an estimated

glomerular filtration < 40 mL/min per m2(body surface area), thiazide diuretics become less effective and loop diuretics should be used instead, such as furosemide, which needs at least twice daily dosing due to its short half-life.

- Aldosterone antagonists, add-on therapy to use in resistant hypertension:

spironolactone 25 mg once a day.

- In order to get better adherence to antihypertensive drug therapy, and better

antihypertensive effects and less side effects, combination medicine is encouraged to use and the use of which class combinations follows guidelines and ASH recommendation(2011),but this is the choice of patients and physicians.

- Renal denervation with catheter-based radiofrequency ablation is not

performed in this trial. 4. To rule out white-coat effect:It has been reported that 20%-30% of patients with apparent resistant hypertension referred for ambulatory BP monitoring in fact have normal BP readings[5].When patients have higher BP levels than 140 over 90 mmHg when measured by the physician than when assessed at home or with AMBP( ambulatory monitoring blood pressure) which is called white-coat hypertension. The patients with white-coat hypertension have less severe target organ damage and cardiovascular risk than those with persistent elevated blood pressure in ambulatory monitoring. 5. Reversing of contributing lifestyle factors for high blood pressure.

- Obesity

- High dietary salt intake (controlled at 6 grams daily as possible as we can).

- The recognition and avoid of other common contributing factors such as

non-steroidal anti-inflammatory drug use, oral contraceptive hormones

- The recognition and treatment of progressive renal impairment.

6. To rule out carefully the potential reversible causes of hypertension by medical history, physical examination, biochemical evaluation, and/ or non-invasive imaging. If diagnosed, pertinent therapy is given to the secondary hypertension:

- Sleep apnoea

- Primary aldosteronism , reported prevalence of approximately 20% in resistant

hypertension[6]

- Renal parenchymal disease and renal artery stenosis

- Aortic coarctation

- Cushing syndrome

- pheochromocytoma

7. Biochemical evaluation, including serum sodium, potassium, glucose, and creatinine (creatinine clearance); plasma aldosterone and renin activity. 8. 24-h urine collection to estimate dietary sodium, potassium, and aldosterone excretion. Testing for urinary or plasma metanephrines/catecholamines is indicated only when pheochromocytoma is suspected 9. Non-invasive imaging is mandatory when there is a suspicion of renal artery stenosis, adrenal adenoma/tumour, parenchymal renal disease or aortic coarctation 2. Target damage: 1. left ventricular hypertrophy: ECG and echocardiography 2. periphery artery disease: ABI,carotid 3. kidney function: urinary microalbumin,cystatin C,creatinine eGFR 4. coronary heart disease 5. Stroke 3. Prognosis: hard endpoint: acute coronary syndrome(including unstable angina,fatal and non-fatal myocardial infarction), stroke, all cause death,cardiovascular death

Eligibility

Minimum age: 30 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

Rutai Hui, Doctor, Phone: 86-010-88398154, Email: huirutai@gmail.com

FuWai Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, Beijing 100037, China; Recruiting
Rutai Hui, Doctor, Phone: +86-10-88398154, Email: huirutai@gmail.com
Rutai Hui, Doctor, Principal Investigator
Xianliang Zhou, Principal Investigator

The general hospital of Chinese People's Liberation Army, Beijing, Beijing 100853, China; Not yet recruiting
Yufeng Li, Principal Investigator

Xuanwu Hospital, Capital Medical University, Beijing, Beijing 100053, China; Not yet recruiting
Qi Hua, Principal Investigator

The First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian 350005, China; Not yet recruiting
Liangdi Xie, Principal Investigator

Nanfang Hospital of southern medical university, Guangzhou, Guangdong 510515, China; Not yet recruiting
Dingli Xu, Principal Investigator

Hongxinglong Center Hospital, Shuangyashan, Heilongjiang 155811, China; Recruiting
Dianjun Gong, Email: hxlkjk@163.com
Dianjun Gong, Principal Investigator
Dianwen Wang, Principal Investigator

Henan Provincial People's Hospital, Zhengzhou, Henan 450000, China; Not yet recruiting
Hao Wang, Principal Investigator

TongJi Hospital, TongJi Medical Colleage, HuaZhong University of Science and Technology, Wu Han, Hubei 430000, China; Not yet recruiting
Daowen Wang, Principal Investigator

The Third People's Hospital of Xuzhou, Xuzhou, Jiangsu 221005, China; Not yet recruiting
Lanying Wang, Principal Investigator
Shuhong Ren, Principal Investigator

The First Bethun Hospital of Jilin University, Changchun, Jilin 130012, China; Not yet recruiting
Yang Zheng, Principal Investigator

Affiliated Hospital of Jining Medical University, Jining, Shandong 272000, China; Not yet recruiting
Qingxian Li, Principal Investigator

Qingdao Municipal Hospital, QingDao, Shandong 266300, China; Not yet recruiting
Xu Wang, Principal Investigator

Rizhao Port Hospital, Rizhao, Shandong 276826, China; Recruiting
Jun Zheng, Email: rzgkyy@163.com
Jun Zheng, Principal Investigator

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai 200025, China; Not yet recruiting
Yan Li, Principal Investigator

First Hospital of Shanxi Medical University, TaiYuan, Shanxi 030001, China; Not yet recruiting
Chuanshi Xiao, Principal Investigator

The fourth military medical university, Xi'an, Shanxi, China; Not yet recruiting
Lianyou Zhao, Principal Investigator

West China Hospital,Sichuan Univer, ChengDu, Sichuan 610041, China; Not yet recruiting
Xiaoping Chen, Principal Investigator

Tianjin Chest Hospital, Tianjin, Tianjin 300051, China; Not yet recruiting
Qin Qin, Principal Investigator

Additional Information

Related publications:

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.

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.

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.

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.

Brown MA, Buddle ML, Martin A. Is resistant hypertension really resistant? Am J Hypertens. 2001 Dec;14(12):1263-9.

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.

Starting date: July 2012
Last updated: October 23, 2012

Page last updated: August 23, 2015

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