Safety and Efficacy of Remote Ischemic Conditioning Treatment for Community-based Essential Hypertension

Essential Hypertension Clinical Trial

Official title:

Safety and Efficacy of Remote Ischemic Conditioning Treatment for Community-based Essential Hypertension: a Randomized, Parallel-controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03945305
• Other study ID #: SERIC-EH
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: April 28, 2024

Study information

• Verified date: February 2024
• Source: The First Hospital of Jilin University
• Contact: Yi Yang, MD,PhD
• Phone: 0086-13756661217
• Email: doctor_yangyi[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to explore the efficacy and safety of remote ischemic conditioning for essential hypertension in the community population.

Description:

At present, stroke has become the leading cause of death in China, with hypertension being the primary risk factor and one of the controllable risk factors. Current studies have shown that remote ischemic conditioning can improve vascular endothelial function, inhibit sympathetic nervous system activity and regulate immune and inflammatory reactions. Thus it may exert anti-hypertensive effects through multiple mechanisms. The purpose of this study is to investigate the efficacy and safety of remote ischemic conditioning for essential hypertension in the community population.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: April 28, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age=40 years, = 75 years, regardless of sex;

2. Having the history of essential hypertension and the systolic blood pressure of at least 140 mm Hg on two consective days;

3. Signed and dated informed consent is obtained

Exclusion Criteria:

1. Blood pressure = 180/110mmHg;

2. Planned adjustment of antihypertensive drugs in the next month;

3. Severe hematologic disorders or significant coagulation abnormalities;

4. Individuals who had contraindication of remote ischemic conditioning, such as severe soft tissue injury, fracture or vascular injury in the upper limb, acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc;

5. Pregnant or lactating women;

6. Severe hepatic and renal dysfunction, or ALT/AST >3 times upper limit of normal, or serum creatinine >265umol/l (>3mg/dl);

7. Patients being enrolled or having been enrolled in another clinical trial within the 3 months prior to this clinical trial;

8. Patients unsuitable for enrollment in the clinical trial according to the investigator's discretion.

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Device:
• Patients are treated with previous antihypertensive treatment plus remote ischemic conditioning.
Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mmHg.

Other:
• Previous antihypertensive treatment
Patients are only treated with previous antihypertensive treatment.

Locations

Country	Name	City	State
China	First Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Yi Yang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of mean systolic blood pressure	The mean systolic blood pressure in the last 3 days of treatment minus baseline mean systolic blood pressure	12-14 days
Secondary	Mean systolic blood pressure level	Mean systolic blood pressure levels during the last 3 days of treatment	12-14 days
Secondary	Changes of mean diastolic blood pressure	The mean diastolic blood pressure in the last 3 days of treatment minus baseline mean diastolic blood pressure	12-14 days
Secondary	Mean diastolic blood pressure level	Mean diastolic blood pressure levels during the last 3 days of treatment	12-14 days
Secondary	Blood pressure compliance rate	Blood pressure compliance rates after treatment	15-28 days