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

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

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

Study Overview

• Status: Recruiting
• Conditions: Essential Hypertension
• Intervention / Treatment: Device: Patients are treated with previous antihypertensive treatment plus remote ischemic conditioning.; Other: Previous antihypertensive treatment

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yi Yang, MD,PhD; Phone Number: 0086-13756661217; Email: doctor_yangyi@163.com
• Study Contact Backup: Name: Zhen-Ni Guo, MD; Email: zhen1ni2@163.com

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130000
      • Recruiting
      • First Hospital of Jilin University
      • Contact: Yi Yang, MD, PhD; Email: doctor_yangyi@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: RIC group; Patients are treated with previous antihypertensive treatment plus remote ischemic conditioning.	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: Control group; Patients are only treated with previous antihypertensive treatment.	Other: Previous antihypertensive treatment; Patients are only treated with previous antihypertensive treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean systolic blood pressure level	Mean systolic blood pressure levels during the last 3 days of treatment	12-14 days
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
Mean diastolic blood pressure level	Mean diastolic blood pressure levels during the last 3 days of treatment	12-14 days
Blood pressure compliance rate	Blood pressure compliance rates after treatment	15-28 days

Collaborators and Investigators

• Sponsor: Yi Yang
• Investigators: Study Chair: Yi Yang, MD,PhD, Department of Neurology, The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): April 28, 2024

Study Registration Dates

• First Submitted: May 8, 2019
• First Submitted That Met QC Criteria: May 8, 2019
• First Posted (Actual): May 10, 2019

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Essential Hypertension, Remote Ischemic Conditioning
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension; Antihypertensive Agents
• Other Study ID Numbers: SERIC-EH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No