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

Sponsor

China Academy of Chinese Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT01904695

Collaborator

Guang'anmen Hospital of China Academy of Chinese Medical Sciences (Other)

192

Enrollment

Location

Arms

Duration (Months)

6.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Hypertension Hypertension, Resistant to Conventional Therapy	Drug: Herbs Drug: Antihypertensive drugs	Early Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

192 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2013

Actual Primary Completion Date :

Oct 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Systolic (SBP) and diastolic (DBP) blood pressure reductions [Before treatment, 8 weeks during treatment]

Secondary Outcome Measures

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

Possible side effects and adverse reactions [2 weeks, 4 weeks, 6 weeks, 8 weeks during treatment and 24 weeks follow-up]
Possible side effects and adverse reactions arising from the treatment like diarrhea will be recorded

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.