Chinese Medicine Treat for Hypertensive Renal Injury

Hypertension Clinical Trial

— CHAIR  

Official title:

Qianyangyuyin Formula Prevent and Treat for Early Renal Injury in Hypertensive Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04078711
• Other study ID #: 2019NL-086-02
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: September 10, 2019
• Est. completion date: December 30, 2021

Study information

• Verified date: September 2019
• Source: Jiangsu Province Hospital of Traditional Chinese Medicine
• Contact: Ming Liu
• Phone: 13815885859
• Email: liumingxinghua[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates whether the traditional chinese medicine (Qianyangyuyin formula) could prevent and treat early renal injury in patients with hypertension and microalbuminuria (defined as a urinary albumin to creatinine ratio between 30 and 300 mg/g) based on standard antihypertensive treatment.

Description:

Hypertension is the main cardiovascular disease and the most important risk factor for severe lethal and disabling diseases such as stroke, myocardial infarction, heart failure, and chronic renal insufficiency. The higher the blood pressure level, the higher the risk of these diseases. Antihypertensive drugs can control blood pressure, and effectively reduce the risk of these serious complications. A multi-center, randomized, parallel, placebo-controlled clinical study was designed to explore the effectiveness and safety of early intervention of Chinese medicine (Qianyanguuyin formula) in improving urinary albumin to creatinine ratio (ACR), based on standard antihypertensive treatment (losartan 100mg qd, if necessary combined with calcium channel blockers). Patients were recruited if they were (1) age between 35 and 55 years old, (2) primary hypertension (grades 2-3 ), (3) microalbuminuria (ACR of 30-300 mg/g) and eGFR of at least 60 ml / (min∙1.73m2), (4) ascendant hyperactivity of liver Yang or Yin deficiency in TCM syndrome. It's intented to form a standardized plan for the prevention and treatment of early renal injury in hypertensive patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 520
• Est. completion date: December 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 55 Years

Eligibility

Inclusion Criteria:

• Subject has primary hypertension(grades 2-3)

• Subject has microalbuminuria [defined as a urinary albumin/creatinine ratio (UACR) between 30 and 300mg/g, and a eGFR at least 60ml/(min·1.73m2)]

• Subject has ascendant hyperactivity of liver Yang or Yin deficiency in TCM syndrome

• Subject voluntarily participates in the trial and signs informed consent

Exclusion Criteria:

• Subject has secondary hypertension

• Subject with pregnancy or lactating

• Subject has serious life-threatening diseases, such as acute myocardial infarction, stroke, heart failure (NYHA IV), and malignant arrhythmia

• Subject's liver function (AST or ALT) is 2 times greater than normal value

• Subject has history of mental illness

• Subject currently participates in other drug clinical trials

Related Conditions & MeSH terms

• Hypertension
• Renal Injury
• Wounds and Injuries

Intervention

Drug:
• Losartan 100Mg Tab
100Mg Tab, qd, po, 6 months
• Qianyangyuyin 20g Granule
20g, Granule, bid, po, 6 months
• placebo
Similar granule manufactured to mimic qianyangyuyin granule, 20g, Granule, bid, po, 6 months

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Jiangsu Province Hospital of Traditional Chinese Medicine	Ministry of Science and Technology of the People´s Republic of China, The affiliated hospital of Liaoning University of Traditional Chinese Medicine, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

References & Publications (11)

Gaziano TA, Bitton A, Anand S, Weinstein MC; International Society of Hypertension. The global cost of nonoptimal blood pressure. J Hypertens. 2009 Jul;27(7):1472-7. doi: 10.1097/HJH.0b013e32832a9ba3. — View Citation

Haller H, Ito S, Izzo JL Jr, Januszewicz A, Katayama S, Menne J, Mimran A, Rabelink TJ, Ritz E, Ruilope LM, Rump LC, Viberti G; ROADMAP Trial Investigators. Olmesartan for the delay or prevention of microalbuminuria in type 2 diabetes. N Engl J Med. 2011 Mar 10;364(10):907-17. doi: 10.1056/NEJMoa1007994. — View Citation

James PA, Oparil S, Carter BL, Cushman WC, Dennison-Himmelfarb C, Handler J, Lackland DT, LeFevre ML, MacKenzie TD, Ogedegbe O, Smith SC Jr, Svetkey LP, Taler SJ, Townsend RR, Wright JT Jr, Narva AS, Ortiz E. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014 Feb 5;311(5):507-20. doi: 10.1001/jama.2013.284427. Erratum in: JAMA. 2014 May 7;311(17):1809. — View Citation

Joint Committee for Guideline Revision. 2018 Chinese Guidelines for Prevention and Treatment of Hypertension-A report of the Revision Committee of Chinese Guidelines for Prevention and Treatment of Hypertension. J Geriatr Cardiol. 2019 Mar;16(3):182-241. doi: 10.11909/j.issn.1671-5411.2019.03.014. — View Citation

Kunz R, Friedrich C, Wolbers M, Mann JF. Meta-analysis: effect of monotherapy and combination therapy with inhibitors of the renin angiotensin system on proteinuria in renal disease. Ann Intern Med. 2008 Jan 1;148(1):30-48. Epub 2007 Nov 5. — View Citation

Li X, Zhang J, Huang J, Ma A, Yang J, Li W, Wu Z, Yao C, Zhang Y, Yao W, Zhang B, Gao R; Efficacy and Safety of Qili Qiangxin Capsules for Chronic Heart Failure Study Group. A multicenter, randomized, double-blind, parallel-group, placebo-controlled study of the effects of qili qiangxin capsules in patients with chronic heart failure. J Am Coll Cardiol. 2013 Sep 17;62(12):1065-1072. doi: 10.1016/j.jacc.2013.05.035. Epub 2013 Jun 7. — View Citation

Mancia G, Fagard R, Narkiewicz K, Redón J, Zanchetti A, Böhm M, Christiaens T, Cifkova R, De Backer G, Dominiczak A, Galderisi M, Grobbee DE, Jaarsma T, Kirchhof P, Kjeldsen SE, Laurent S, Manolis AJ, Nilsson PM, Ruilope LM, Schmieder RE, Sirnes PA, Sleight P, Viigimaa M, Waeber B, Zannad F; Task Force Members. 2013 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). J Hypertens. 2013 Jul;31(7):1281-357. doi: 10.1097/01.hjh.0000431740.32696.cc. — View Citation

National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266. — View Citation

Ruggenenti P, Fassi A, Ilieva A, Iliev IP, Chiurchiu C, Rubis N, Gherardi G, Ene-Iordache B, Gaspari F, Perna A, Cravedi P, Bossi A, Trevisan R, Motterlini N, Remuzzi G; BENEDICT-B Study Investigators. Effects of verapamil added-on trandolapril therapy in hypertensive type 2 diabetes patients with microalbuminuria: the BENEDICT-B randomized trial. J Hypertens. 2011 Feb;29(2):207-16. — View Citation

Schmieder RE, Hilgers KF, Schlaich MP, Schmidt BM. Renin-angiotensin system and cardiovascular risk. Lancet. 2007 Apr 7;369(9568):1208-19. Review. — View Citation

Zhang L, Wang F, Wang L, Wang W, Liu B, Liu J, Chen M, He Q, Liao Y, Yu X, Chen N, Zhang JE, Hu Z, Liu F, Hong D, Ma L, Liu H, Zhou X, Chen J, Pan L, Chen W, Wang W, Li X, Wang H. Prevalence of chronic kidney disease in China: a cross-sectional survey. Lancet. 2012 Mar 3;379(9818):815-22. doi: 10.1016/S0140-6736(12)60033-6. Erratum in: Lancet. 2012 Aug 18;380(9842):650. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	albumin-to-creatinine ratio(UACR)	UACR tested at baseline and each month. Microalbuminuria was defined as urinary ACR of at least 30mg/g.	6 months
Secondary	Ambulatory blood pressure level	ABPM was measured at baseline, 3 and 6 months. Both systolic and diastolic pressure was assessed. Hypertension was defined as mean ambulatory blood pressure of at least 130/80 mmHg.	6 months
Secondary	Office blood pressure level 6/5000 Office blood pressure level	Office blood pressure was measured at baseline and each month. Both systolic and diastolic pressure was assessed. Hypertension was defined as office blood pressure of at least 140/90 mmHg.	6 months
Secondary	Traditional Chinese Medicine syndrome scores	Self reported TCM syndrome scores at baseline and each month. Each main symptom is scored 0?2?4?6 (0 = no sympton; 6 = as heavy as can be), and each secondary symptom is scored 0?1?2?3(0=no symptom; 3= as heavy as can be).	6 months