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

NCT ID: NCT05845905

Last Updated: 2024-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-10

Study Completion Date

2024-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Essential Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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RIC group

Patients are treated with remote ischemic conditioning (RIC).

Group Type ACTIVE_COMPARATOR

Remote ischemic conditioning

Intervention Type PROCEDURE

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.

Sham RIC group

Patients are treated with sham remote ischemic conditioning (sham-RIC).

Group Type PLACEBO_COMPARATOR

Sham remote ischemic conditioning

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yi Yang

OTHER

Sponsor Role lead

Responsible Party

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Yi Yang

Vice President of First Hospital of Jilin University

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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First Hospital of Jilin University

Changchun, Jilin, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yi Yang, MD, PhD

Role: CONTACT

13756661217 ext. 0086

Zhen-Ni Guo, MD, PhD

Role: CONTACT

18186872986 ext. 0086

Facility Contacts

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Yi Yang, MD, PhD

Role: primary

13756661217 ext. 0086

Other Identifiers

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RICBP-HT

Identifier Type: -

Identifier Source: org_study_id

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