Remote Ischemic Conditioning for the Treatment of Resistant Hypertension

Efficacy and Safety of Remote Ischemic Conditioning for the Treatment of Resistant Hypertension: a Pilot Study

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

Study Overview

• Status: Not yet recruiting
• Conditions: Resistant Hypertension
• Intervention / Treatment: Device: RIC; Device: Sham-RIC

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xunming Ji, MD, PhD; Phone Number: 83199430; Email: jixm@ccmu.edu.cn
• Study Contact Backup: Name: Wenting Guo; Phone Number: 18368910464; Email: 18368910464@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.
Sham Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of 24 h average systolic blood pressure	Changes of 24 h average systolic blood pressure from baseline to 8 weeks	from baseline to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of 24 h average diasolic blood pressure	Changes of 24 h average diasolic blood pressure from baseline to 8 weeks	from baseline to 8 weeks
Changes of daytime average systolic blood pressure	Changes of daytime average systolic blood pressure from baseline to 8 weeks	from baseline to 8 weeks
Changes of daytime average diastolic blood pressure	Changes of daytime average diastolic blood pressure from baseline to 8 weeks	from baseline to 8 weeks
Changes of nighttime average systolic blood pressure	Changes of nighttime average systolic blood pressure from baseline to 8 weeks	from baseline to 8 weeks
Changes of nighttime average diastolic blood pressure	Changes of nighttime average diastolic blood pressure from baseline to 8 weeks	from baseline to 8 weeks
Changes of 24 h average heart rate	Changes of 24 h average heart rate from baseline to 8 weeks	from baseline to 8 weeks
Changes of office systolic blood pressure	Changes of office systolic blood pressure from baseline to 8 weeks	from baseline to 8 weeks
Changes of office diastolic blood pressure	Changes of office diastolic blood pressure from baseline to 8 weeks	from baseline to 8 weeks
Changes of home systolic blood pressure	Changes of home systolic blood pressure from baseline to 8 weeks	from baseline to 8 weeks
Changes of home diastolic blood pressure	Changes of home diastolic blood pressure from baseline to 8 weeks	from baseline to 8 weeks

Collaborators and Investigators

• Sponsor: Ji Xunming,MD,PhD
• Investigators: Principal Investigator: Xunming Ji, MD, PhD, Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): March 30, 2023

Study Registration Dates

• First Submitted: June 16, 2022
• First Submitted That Met QC Criteria: June 16, 2022
• First Posted (Actual): June 22, 2022

Study Record Updates

• Last Update Posted (Actual): September 8, 2022
• Last Update Submitted That Met QC Criteria: September 3, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Resistant Hypertension; Remote ischemic conditioning
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: RIC-Resistant HTN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No