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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by China Academy of Chinese Medical Sciences
Sponsor:
Collaborator:
Guang'an Men Hospital
Information provided by (Responsible Party):
Ya YUWEN, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier:
NCT01904695
First received: July 14, 2013
Last updated: October 15, 2013
Last verified: October 2013
  Purpose

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 clinical effect under real-world 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 multicenter, 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 > 140/90 mm Hg even used to be on 3 or more medications for a month and diagnosed as Phlegm and Stasis Syndrome will be included. 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 participants is enough to calculate sample size in later formal trial.


Condition Intervention Phase
Primary Hypertension
Hypertension, Resistant to Conventional Therapy
Drug: Herbs
Drug: Thiazide diuretics and ACE inhibitor and β-blocker
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by China Academy of Chinese Medical Sciences:

Primary Outcome Measures:
  • Systolic (SBP) and diastolic (DBP) blood pressure reductions [ Time Frame: Before treatment, 8 weeks during treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiac event [ Time Frame: Before treatment, 24 weeks follow-up ] [ Designated as safety issue: No ]
  • Death incident [ Time Frame: Before treatment, 24 weeks follow-up ] [ Designated as safety issue: No ]
  • scores for symptoms and signs [ Time Frame: Before treatment, 8 weeks during treatment ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Possible side effects and adverse reactions [ Time Frame: 2 weeks, 4 weeks, 6 weeks, 8 weeks during treatment and 24 weeks follow-up ] [ Designated as safety issue: Yes ]
    Possible side effects and adverse reactions arising from the treatment like diarrhea will be recorded


Estimated Enrollment: 200
Study Start Date: August 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Thiazide diuretics and ACE inhibitor and β-blocker & 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 Name: recipe of removing both phlegem and blood stasis
Drug: Thiazide diuretics and ACE inhibitor and β-blocker
Thiazide diuretics and ACE inhibitor and β-blocker in different dosage determined by the physician for 8 weeks
Active Comparator: Thiazide diuretics and ACE inhibitor and β-blocker
Thiazide diuretics and ACE inhibitor and β-blocker for 8 weeks
Drug: Thiazide diuretics and ACE inhibitor and β-blocker
Thiazide diuretics and ACE inhibitor and β-blocker in different dosage determined by the physician for 8 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01904695

Locations
China, Beijing
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences Recruiting
Beijing, Beijing, China, 100700
Contact: Ya Yuwen, PhD. MD    86-10-64014411 ext 3404    yuwen_ya@163.com   
Principal Investigator: Ya Yuwen, PhD. MD         
Sponsors and Collaborators
China Academy of Chinese Medical Sciences
Guang'an Men Hospital
  More Information

No publications provided

Responsible Party: Ya YUWEN, Doctor, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT01904695     History of Changes
Other Study ID Numbers: 81202846
Study First Received: July 14, 2013
Last Updated: October 15, 2013
Health Authority: China: Ethics Committee

Keywords provided by China Academy of Chinese Medical Sciences:
resistant hypertension
causal inference
a chorot study
recipe of removing both phlegm and blood stasis

Additional relevant MeSH terms:
Hypertension
Coronary Vasospasm
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Myocardial Ischemia
Heart Diseases
Angiotensin-Converting Enzyme Inhibitors
Diuretics
Sodium Chloride Symporter Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Natriuretic Agents
Physiological Effects of Drugs
Membrane Transport Modulators

ClinicalTrials.gov processed this record on July 31, 2014