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

Sponsor

Yi Yang (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05845905

Collaborator

(none)

158

Enrollment

Location

Arms

11.7

Anticipated Duration (Months)

13.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Essential Hypertension	Procedure: Remote ischemic conditioning Procedure: Sham remote ischemic conditioning	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

158 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Apr 20, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Mean systolic blood pressure [0-7 days]
Difference in mean value of systolic blood pressure during RIC/sham-RIC between two groups.

Secondary Outcome Measures

Mean diastolic blood pressure [0-7 days]
Difference in mean value of diastolic blood pressure during RIC/sham-RIC between two groups.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

1. Secondary hypertension;
1. Clinical blood pressure ≥ 180/110 mmHg or 24-hour mean arterial pressure ≥ 170/100 mmHg;
1. Severe organ dysfunction or failure;
1. Severe hematologic disorders or significant coagulation abnormalities;
1. History of atrial fibrillation or myocardial infarction within 6 months;
1. 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;
1. Individuals who will or have received anticoagulant therapy with drugs such as dabigatran, rivaroxaban, warfarin, etc;
1. 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;
1. Other conditions that the researchers think are not suitable for the project.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First Hospital of Jilin University	Changchun	Jilin	China	130000

Sponsors and Collaborators

Yi Yang

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yi Yang, Vice President of First Hospital of Jilin University, The First Hospital of Jilin University

ClinicalTrials.gov Identifier:

NCT05845905

Other Study ID Numbers:

RICBP-HT

First Posted:

May 6, 2023

Last Update Posted:

May 6, 2023

Last Verified:

Apr 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypertension

Essential Hypertension

Study Results

No Results Posted as of May 6, 2023