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

Essential Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05845905
• Other study ID #: RICBP-HT
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2023
• Est. completion date: April 20, 2024

Study information

• Verified date: February 2024
• Source: The First Hospital of Jilin University
• Contact: Yi Yang, MD, PhD
• Phone: 13756661217
• Email: doctor_yangyi[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 158
• Est. completion date: April 20, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	First Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Yi Yang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean systolic blood pressure	Difference in mean value of systolic blood pressure during RIC/sham-RIC between two groups.	0-7 days
Secondary	Mean diastolic blood pressure	Difference in mean value of diastolic blood pressure during RIC/sham-RIC between two groups.	0-7 days