Remote Ischemic Conditioning for the Treatment of Resistant Hypertension

NCT ID: NCT05426707

Last Updated: 2022-09-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2023-03-30

Brief Summary

This study aims to explore the efficacy and safety of remote ischemia adaptation for the treatment of resistant hypertension.

Detailed Description

Resistant hypertension is defined as a blood pressure of 140/90 mmHg or higher despite adherence to at least three antihypertensive drugs (including one diuretic), accounting for 20% to 30% of patients with hypertension. Compared with patients with well-controlled blood pressure, the cardiovascular risk of resistant hypertension is increased by about 50%. Limb remote ischemic conditioning (LRIC) triggers endogenous protective effects through transient and repeated ischemia in the limb to protect remote tissues and organs. The mechanisms of LRIC involve the regulation of the autonomic nervous system, the release of humoral factors, improvement of vascular endothelial function, and modulation of immune/inflammatory responses, which can antagonize the pathogenesis of hypertension through multiple pathways to lead to a drop in BP theoretically. This theory has been preliminarily confirmed by several small sample-size studies in non-resistant hypertension. This study aims to explore the efficacy and safety of remote ischemia adaptation for the treatment of resistant hypertension.

Conditions

Resistant Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

RIC group

RIC is a non-invasive therapy that is performed by automated pneumatic cuffs placed on bilateral arms. The RIC protocol includes five cycles of 5-min inflation to 200mmHg and 5-min deflation.

Group Type: EXPERIMENTAL

RIC

Intervention Type: DEVICE

RIC is a non-invasive therapy that is performed by automated pneumatic cuffs placed on bilateral arms. The RIC protocol includes five cycles of 5-min inflation to 200mmHg and 5-min deflation.

Sham RIC group

The Sham-RIC protocol include five cycles of 5-min inflation to 60 mmHg and 5-min deflation by placing automated pneumatic cuffs on bilateral arms.

Group Type: SHAM_COMPARATOR

Sham-RIC

Intervention Type: DEVICE

The Sham-RIC protocol include five cycles of 5-min inflation to 60 mmHg and 5-min deflation by placing automated pneumatic cuffs on bilateral arms.

Interventions

RIC

RIC is a non-invasive therapy that is performed by automated pneumatic cuffs placed on bilateral arms. The RIC protocol includes five cycles of 5-min inflation to 200mmHg and 5-min deflation.

Intervention Type: DEVICE

Sham-RIC

The Sham-RIC protocol include five cycles of 5-min inflation to 60 mmHg and 5-min deflation by placing automated pneumatic cuffs on bilateral arms.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Aged 30~80 years old;

• Taking ≥ 3 antihypertensive drugs (including one diuretic) for more than 4 weeks regularly;

• Office blood pressure ≥ 140/90mmhg, and 24 h average blood pressure ≥ 130/80 mmHg;

• Willing to participate in the study, follow the study protocol, and provide informed consent.

Exclusion Criteria

• Secondary hypertension;

• eGFR<45ml/min/1.73m2；

• Office blood pressure ≥180/110 mmHg, and 24 h average blood pressure ≥ 170/100 mmHg；

• Hypertensive crisis occurred within 3 months;

• Type 1 diabetes;

• Cardiovascular events occurred within 3 months;

• Atrial fibrillation;

• Presence of any severe disease that adversely affects the subject or study;

• Patients with contraindication for remote ischemic conditioning, such as vascular injury, soft tissue injury, orthopedic injury, or arm infection;

• Pregnancy, lactation, or planned pregnancy;

• Patients not suitable for this trial considered by researchers for other reasons；

• Participation in another device or drug trial simultaneously.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ji Xunming,MD,PhD

OTHER

Sponsor Role: lead

Responsible Party

Ji Xunming,MD,PhD

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Xunming Ji, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Beijing

Central Contacts

Xunming Ji, MD, PhD

Role: CONTACT

jixm@ccmu.edu.cn

83199430

Wenting Guo

Role: CONTACT

18368910464@163.com

18368910464

Other Identifiers

RIC-Resistant HTN

Identifier Type: -

Identifier Source: org_study_id