Causal Inference Research of Resistant Hypertension Treatment With Chinese Approach in a Cohort Study

Causal Inference Research of Resistant Hypertension Treatment With Recipe of Removing Both Phlegm and Blood Stasis in a Real World Study

The research of clinical effectiveness assessment is to explore the causal relationship between treatment and outcome.Accordingly, based on the effectiveness of tan-yu treatment, the research takes the Resistant Hypertension (RH) as example to study the causal inference methods under real world.

Study Overview

• Status: Completed
• Conditions: Hypertension, Resistant to Conventional Therapy; Primary Hypertension
• Intervention / Treatment: Drug: Herbs; Drug: Antihypertensive drugs

Detailed Description

Background: Syndrome differentiation is one of the substantial characteristics in Traditional Chinese Medicine (TCM) but is still lack of scientific evidence.The inference methods of causal relationship between treatment and clinial effect under real-word study may help.

Objectives: This study aims to assess the efficacy of Phlegm and Stasis Syndrome differentiation method in treating resistant hypertension and explore causal inference in the real-world study.

Research design and methods: It is a multi-center,prospective,two-arm,cohort study including 200 patients with resistant hypertension (doctors' diagnosis based on the American Heart Association criteria 2008).Essential hypertension subjects,aged 18-70 years,blood pressure >140/90mmHg even used to be on 3 or more medications for a month and diagnosed as Phlegm and Stasis Syndrome will be included.Thiazide diuretics and/or two more antihypertensive agents for 8 weeks, Chinese herbs (for synchronic treating phlegm and blood stasis) and nonpharmacological recommendations were initiated in the observational group and the control group received the same interventions without Chinese herbs.

Outcome measures: The primary outcomes will be Systolic (SBP) and Diastolic (DBP) blood pressure reductions and changes in symptoms and signs.Cardiac event and death incident will be the secondary outcomes.Possible side effects and adverse reactions arising from the treatment like diarrhea will be recorded.

Discussion: This is a rigorous methodology pilot study and 200 patients are enough to calculate sample size in later formal trial.

• Study Type: Interventional
• Enrollment (Actual): 192
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100700
      • Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Essential hypertension subjects, aged 18-70 years, blood pressure > 140/90 mm Hg even used to be on 3 or more medications for a month and diagnosed as Phlegm and Stasis Syndrome will be included.

Exclusion Criteria:

• Patients will be excluded for the following conditions: with secondary resistant hypertension because of other disease like renal disease or pheochromocytoma; included in other clinical trial in one month; pregnant or breast-feed or preparing for pregnancy female; combined with disease like stroke, coronary atherosclerotic heart disease, diabetes, chronic renal failure or mental disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Antihypertensive drugs & Herbs; Thiazide diuretics and ACE inhibitor and β-blocker & Herbs for 8 weeks	Drug: Herbs; Herbs 180ml by mouth every 12 hours for 8 weeks; Other Names: recipe of removing both phlegem and blood stasis; Drug: Antihypertensive drugs; Thiazide diuretics and ACE inhibitor and β-blocker in different dosage determined by the physician for 8 weeks; Other Names: Thiazide diuretics and ACE inhibitor and β-blocker
ACTIVE_COMPARATOR: Antihypertensive drugs; Thiazide diuretics and ACE inhibitor and β-blocker for 8 weeks	Drug: Antihypertensive drugs; Thiazide diuretics and ACE inhibitor and β-blocker in different dosage determined by the physician for 8 weeks; Other Names: Thiazide diuretics and ACE inhibitor and β-blocker

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Systolic (SBP) and diastolic (DBP) blood pressure reductions	Before treatment, 8 weeks during treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Cardiac event	Before treatment, 24 weeks follow-up
Death incident	Before treatment, 24 weeks follow-up
Scores for symptoms and signs	Before treatment, 8 weeks during treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Possible side effects and adverse reactions	Possible side effects and adverse reactions arising from the treatment like diarrhea will be recorded	2 weeks, 4 weeks, 6 weeks, 8 weeks during treatment and 24 weeks follow-up

Collaborators and Investigators

• Sponsor: China Academy of Chinese Medical Sciences
• Collaborators: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Investigators: Study Director: Ya YUWEN, PhD, China Academy of Chinese Medical Sciences

Publications and helpful links

General Publications

• Yuwen Y, Liu YQ, Wang YP, Dai JG, Liu DS, Wang YX, Han XJ. The add-on effect of a Chinese herbal formula for patients with resistant hypertension: study protocol for a pilot cohort study. J Integr Med. 2015 Mar;13(2):122-8. doi: 10.1016/S2095-4964(15)60162-5.

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (ACTUAL): October 1, 2015
• Study Completion (ACTUAL): December 1, 2015

Study Registration Dates

• First Submitted: July 14, 2013
• First Submitted That Met QC Criteria: July 17, 2013
• First Posted (ESTIMATE): July 22, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): September 7, 2016
• Last Update Submitted That Met QC Criteria: September 4, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: resistant hypertension; causal inference; a chorot study; recipe of removing both phlegm and blood stasis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Natriuretic Agents; Membrane Transport Modulators; Antihypertensive Agents; Diuretics; Angiotensin-Converting Enzyme Inhibitors; Sodium Chloride Symporter Inhibitors
• Other Study ID Numbers: 81202846

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO