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

NCT05845905 | Recruiting

• 1 other identifier: RICBP-HT
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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.

Conditions

Essential Hypertension

Outcome Measures

Primary Outcomes (1)

• Mean systolic blood pressure

  Difference in mean value of systolic blood pressure during RIC/sham-RIC between two groups.

  0-7 days

Secondary Outcomes (1)

• Mean diastolic blood pressure

  0-7 days

Study Arms (2)

RIC group

ACTIVE COMPARATOR

Patients are treated with remote ischemic conditioning (RIC).

Procedure: Remote ischemic conditioning

Sham RIC group

PLACEBO COMPARATOR

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

Procedure: Sham remote ischemic conditioning

Interventions

Remote ischemic conditioning 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.

RIC group

Sham remote ischemic conditioning 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.

Sham RIC group

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yi Yang: lead

Study Sites (1)

First Hospital of Jilin University

Changchun, Jilin, 130000, China

RECRUITING

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Yi Yang, MD, PhD

CONTACT

13756661217; doctor_yangyi@163.com

Zhen-Ni Guo, MD, PhD

CONTACT

18186872986; zhen1ni2@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice President of First Hospital of Jilin University

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: May 6, 2023
• Study Start: May 10, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 2, 2024

Record last verified: 2024-10

Locations

CN (1)