Clinical trial NCT05426707: Remote Ischemic Conditioning for the Treatment of Resistant Hypertension
Official title: Efficacy and Safety of Remote Ischemic Conditioning for the Treatment of Resistant Hypertension: a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Resistant Hypertension
Keywords: Resistant Hypertension
Remote ischemic conditioning
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2022-06-22
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Changes of 24 h average systolic blood pressure
timeFrame: from baseline to 8 weeks
Secondary outcomes:
measure: Changes of 24 h average diasolic blood pressure
timeFrame: from baseline to 8 weeks
measure: Changes of daytime average systolic blood pressure
timeFrame: from baseline to 8 weeks
measure: Changes of daytime average diastolic blood pressure
timeFrame: from baseline to 8 weeks
measure: Changes of nighttime average systolic blood pressure
timeFrame: from baseline to 8 weeks
measure: Changes of nighttime average diastolic blood pressure
timeFrame: from baseline to 8 weeks
measure: Changes of 24 h average heart rate
timeFrame: from baseline to 8 weeks
measure: Changes of office systolic blood pressure
timeFrame: from baseline to 8 weeks
measure: Changes of office diastolic blood pressure
timeFrame: from baseline to 8 weeks
measure: Changes of home systolic blood pressure
timeFrame: from baseline to 8 weeks
measure: Changes of home diastolic blood pressure
timeFrame: from baseline to 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Xunming Ji, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: