Remote Ischemic Conditioning for the Treatment of Resistant Hypertension

Sponsor
Ji Xunming,MD,PhD (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05426707
Collaborator
(none)
40
2
8.9

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: RIC
  • Device: Sham-RIC
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Remote Ischemic Conditioning for the Treatment of Resistant Hypertension: a Pilot Study
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Mar 30, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Changes of 24 h average systolic blood pressure [from baseline to 8 weeks]

    Changes of 24 h average systolic blood pressure from baseline to 8 weeks

Secondary Outcome Measures

  1. Changes of 24 h average diasolic blood pressure [from baseline to 8 weeks]

    Changes of 24 h average diasolic blood pressure from baseline to 8 weeks

  2. Changes of daytime average systolic blood pressure [from baseline to 8 weeks]

    Changes of daytime average systolic blood pressure from baseline to 8 weeks

  3. Changes of daytime average diastolic blood pressure [from baseline to 8 weeks]

    Changes of daytime average diastolic blood pressure from baseline to 8 weeks

  4. Changes of nighttime average systolic blood pressure [from baseline to 8 weeks]

    Changes of nighttime average systolic blood pressure from baseline to 8 weeks

  5. Changes of nighttime average diastolic blood pressure [from baseline to 8 weeks]

    Changes of nighttime average diastolic blood pressure from baseline to 8 weeks

  6. Changes of 24 h average heart rate [from baseline to 8 weeks]

    Changes of 24 h average heart rate from baseline to 8 weeks

  7. Changes of office systolic blood pressure [from baseline to 8 weeks]

    Changes of office systolic blood pressure from baseline to 8 weeks

  8. Changes of office diastolic blood pressure [from baseline to 8 weeks]

    Changes of office diastolic blood pressure from baseline to 8 weeks

  9. Changes of home systolic blood pressure [from baseline to 8 weeks]

    Changes of home systolic blood pressure from baseline to 8 weeks

  10. Changes of home diastolic blood pressure [from baseline to 8 weeks]

    Changes of home diastolic blood pressure from baseline to 8 weeks

  11. Changes of blood biomarkers [from baseline to 8 weeks]

    Changes of blood biomarkers which have been demonstrated to correlate with hypertension, such as NO、ET-1、IL-10、TNF-α、IL-1β、SDF-1α, from baseline to 8 weeks.

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

① Aged 30~80 years old; ② Taking ≥ 3 antihypertensive drugs (including one diuretic) for more than 4 weeks regularly; ③ Office blood pressure ≥ 140/90mmhg, and 24 h average blood pressure ≥ 130/80 mmHg; ④ Willing to participate in the study, follow the study protocol, and provide informed consent.

Exclusion Criteria:

① Secondary hypertension; ② eGFR<45ml/min/1.73m2;③ Office blood pressure ≥180/110 mmHg, and 24 h average blood pressure ≥ 170/100 mmHg;④ Hypertensive crisis occurred within 3 months; ⑤ Type 1 diabetes; ⑥ Cardiovascular events occurred within 3 months; ⑦ Atrial fibrillation; ⑧ Presence of any severe disease that adversely affects the subject or study; ⑨ Patients with contraindication for remote ischemic conditioning, such as vascular injury, soft tissue injury, orthopedic injury, or arm infection; ⑩ Pregnancy, lactation, or planned pregnancy; ⑪ Patients not suitable for this trial considered by researchers for other reasons;⑫ Participation in another device or drug trial simultaneously.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Ji Xunming,MD,PhD

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ji Xunming,MD,PhD, Professor, Capital Medical University
ClinicalTrials.gov Identifier:
NCT05426707
Other Study ID Numbers:
  • RIC-Resistant HTN
First Posted:
Jun 22, 2022
Last Update Posted:
Jun 22, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ji Xunming,MD,PhD, Professor, Capital Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 22, 2022