Remote Ischemic Conditioning for the Treatment of Resistant Hypertension

Ji Xunming,MD,PhD

Status: Not yet enrolling

Conditions: Resistant Hypertension

Treatments: Device: Sham-RIC; Device: RIC

Study type: Interventional

Funder types: Other

Identifiers

NCT05426707

RIC-Resistant HTN

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

RIC group

Experimental group

Description:

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.

Treatment:

Device: RIC

Sham RIC group

Sham Comparator group

Description:

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.

Treatment:

Device: Sham-RIC