The Standardized Management of Hypertension in Rural Shaanxi

NCT04371874 | Completed

• 1 other identifier: GS610101-Ⅰ
• Study Type: interventional
• Target: 1,210
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to build a prevention and management system of hypertension in rural Shaanxi, China, which tries to use the standardized and economical methods to improve the outcome of chronic cardiovascular diseases.

Conditions

Hypertension

Keywords

hypertension management; rural areas; control rate

Outcome Measures

Primary Outcomes (1)

• the improvement of control rate of hypertension with low-cost in rural Shaanxi

  value whether the protocol of TDP could improve the control rate of hypertension in rural Shaanxi

  Patients in the TDP group accepted protocol of TDP to manage hypertension and patients in the control group were managed by the original protocol for six months. Compare the change of control rate at baseline and the end of the sixth month.

Study Arms (2)

Control

NO INTERVENTION

Hypertension of patients in the control group was managed with the original protocol including lifestyle by doctors in village clinic.

Treatment with Ten Dollars Project (TDP)

EXPERIMENTAL

Hypertension of patients in the TDP group were managed with the protocol of "Ten Dollars Project (TDP)" by doctors in village clinic.

Drug: Hydrochlorothiazide, Captopril, Nitrendipine, Aspirin

Interventions

Hydrochlorothiazide, Captopril, Nitrendipine, Aspirin DRUG

The participants were grouped into a control group and a TDP group. Hypertension of patients in the control group was managed with the original protocol by doctors in village clinics. Patients in the TDP group were supplied with the TDP treatment, for whom different levels of oral administration plans to patients without drugs treatment in original protocol were: G 0 and G I, nifedipine (20mg, bid) or captopril (25mg, tid), hydrochlorothiazide (12.5mg, bid) for patients who couldn't tolerate previous drugs; G II, nifedipine (20mg, bid) plus hydrochlorothiazide (12.5mg, bid), or captopril (25mg, tid) plus hydrochlorothiazide (12.5mg, bid ), triple therapy for patients whose blood pressure did not reach target BP; G III, three drugs combination. Patients with drugs treatments in the original protocol were changed to be treated with the above antihypertension medications which were uniformly supplied by the government.

Also known as: medications were uniformly supplied by the Chinese government

Treatment with Ten Dollars Project (TDP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• primary hypertension;
• Age ≥ 18 years old;

You may not qualify if:

• Secondary hypertension;
• the acute onset of cardiovascular events within three months;
• severe liver disease (ALT increased 2-fold greater than creatinine 2.5mg/dl);
• Severe cardiomyopathy, congenital heart disease, rheumatic heart disease
• malignancies
• allergic to study drugs
• with clear contraindications on study drugs

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

the first affiliated hospital of Xi'an Jiaotong university

Xi'an, China

Location

MeSH Terms

Conditions

Hypertension

Interventions

Hydrochlorothiazide; Captopril; Nitrendipine; Aspirin

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Proline; Imino Acids; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Hongyan Tian

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice director

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 1, 2020
• Study Start: January 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: February 1, 2019
• Last Updated: May 1, 2020

Record last verified: 2020-04

Locations

CN (1)