Effects of Remote Ischemic Conditioning on Blood Pressure in Older Patients With Hypertension

The purpose of this study is to learn about effects of remote ischemic conditioning on blood pressure in older patients with essential hypertension.

Study Overview

• Status: Recruiting
• Conditions: Essential Hypertension
• Intervention / Treatment: Procedure: Remote ischemic conditioning; Procedure: Sham remote ischemic conditioning

Detailed Description

Current studies have shown that remote ischemic conditioning can improve vascular endothelial function and inhibit sympathetic nervous system activity. Thus it may provide some organ protection as well as anti-hypertensive effects. The purpose of this study is to learn about effects of remote ischemic conditioning on blood pressure in older patients with essential hypertension.

• Study Type: Interventional
• Enrollment (Estimated): 158
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhen-Ni Guo, MD, PhD; Phone Number: 0086 18186872986; Email: zhen1ni2@163.com
• Study Contact Backup: Name: Yi Yang, MD, PhD; Phone Number: 0086 13756661217; Email: doctor_yangyi@163.com

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130000
      • Recruiting
      • First Hospital of Jilin University
      • Contact: Yi Yang, MD, PhD; Phone Number: 0086 13756661217; Email: doctoryangyi@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1) Age ≥65 years and ≤85 years, regardless of gender;
• 2) History of essential hypertension and clinical systolic blood pressure ≥ 140 mmHg, regardless of whether they are receiving antihypertensive medication;
• 3) Willing to participate and sign the informed consent.

Exclusion Criteria:

• 1) Secondary hypertension;
• 2) Clinical blood pressure ≥ 180/110 mmHg or 24-hour mean arterial pressure ≥ 170/100 mmHg;
• 3) Severe organ dysfunction or failure;
• 4) Severe hematologic disorders or significant coagulation abnormalities;
• 5) History of atrial fibrillation or myocardial infarction within 6 months;
• 6) 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;
• 7) Individuals who will or have received anticoagulant therapy with drugs such as dabigatran, rivaroxaban, warfarin, etc;
• 8) Those who are participating in other clinical research or has participated in other clinical research or has participated in this study within 3 months prior to enrollment;
• 9) Other conditions that the researchers think are not suitable for the project.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: RIC group; Patients are treated with remote ischemic conditioning (RIC).	Procedure: 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 the inflation of an automated cuff to the pressure rising by 20 mmHg from baseline systolic pressure. RIC will be conducted twice daily for 7 days.
Placebo Comparator: Sham RIC group; Patients are treated with sham remote ischemic conditioning (sham-RIC).	Procedure: Sham remote ischemic conditioning; Sham-RIC is performed in the same way as the treatment group except that the blood pressure cuff is inflated to 60 mmHg, which produces mild pressure sensations but has no blocking impact on blood flow.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean systolic blood pressure	Difference in mean value of systolic blood pressure during RIC/sham-RIC between two groups.	0-7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean diastolic blood pressure	Difference in mean value of diastolic blood pressure during RIC/sham-RIC between two groups.	0-7 days

Collaborators and Investigators

• Sponsor: Yi Yang

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 20, 2024

Study Registration Dates

• First Submitted: April 13, 2023
• First Submitted That Met QC Criteria: April 26, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

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

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension
• Other Study ID Numbers: RICBP-HT

Drug and device information, study documents

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