NCT04915313

Brief Summary

This study intends to further reveal the antihypertensive effect of LRIC and explore its potential mechanisms.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 7, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

June 15, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

November 10, 2022

Status Verified

November 1, 2022

Enrollment Period

12 months

First QC Date

June 1, 2021

Last Update Submit

November 8, 2022

Conditions

Hypertension,EssentialPrehypertension

Keywords

Remote ischemic conditioningEssential hypertensionPrehypertensionBlood pressure

Outcome Measures

Primary Outcomes (1)

  • Changes of average 24-h ambulatory systolic blood pressure.

    Changes of average 24-h ambulatory systolic blood pressure from baseline to four weeks.

    From baseline to 4 weeks.

Secondary Outcomes (12)

  • Changes of average 24-h ambulatory diastolic blood pressure.

    From baseline to 4 weeks.

  • Changes of average daytime ambulatory systolic blood pressure.

    From baseline to 4 weeks.

  • Changes of average daytime ambulatory diastolic blood pressure.

    From baseline to 4 weeks.

  • Changes of average night-time ambulatory systolic blood pressure.

    From baseline to 4 weeks.

  • Changes of average night-time ambulatory diastolic blood pressure.

    From baseline to 4 weeks.

  • +7 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Subjects in the intervention group will recieve remote ischemic conditioning (RIC) treatment twice a day for 4 weeks.

Device: Remote ischemic conditioning (RIC)

Sham control group

SHAM COMPARATOR

Subject in the sham control group will recieve sham remote ischemic conditioning (Sham-RIC) treatment twice a day for 4 weeks..

Device: Sham remote ischemic conditioning (Sham-RIC)

Interventions

Remote ischemic conditioning (RIC)DEVICE

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

Intervention group
Sham remote ischemic conditioning (Sham-RIC)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.

Sham control group

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 50-80 years；
  • Office blood pressure ≥130/80mmHg and\<160/100mmHg; and 24-h ambulatory systolic/diastolic blood pressure ≥125/75mmHg;
  • Never taking antihypertensive drugs or have stopped taking antihypertensive drugs for more than one month;
  • Do not receive any antihypertensive drugs during the research;
  • Informed consent obtained from the subjects or their legally authorized representative.

You may not qualify if:

  • Secondary hypertension;
  • Patients who are taking antihypertensive drugs regularly;
  • Patients with contraindication for remote ischemic conditioning, such as vascular injury, soft tissue injury, orthopedic injury, or arm infection;
  • Patients with bleeding disorder;
  • Patients with atrial fibrillation or other severe arrhythmias；
  • Patients with prior myocardial infarction or stroke；
  • Patients with serious or unstable medical condition, such as severe liver or kidney dysfunction, heart failure, respiratory failure, malignant tumors, or autoimmune diseases;
  • Participation in another device or drug trial simultaneously;
  • Patients who are not suitable for this trial considered by researchers for other reasons.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

Peking University Care Health Management Center

Beijing, Beijing Municipality, 100080, China

Location

The 306 Hospital of People's Liberation Army

Beijing, Beijing Municipality, 100101, China

Location

Related Publications (4)

  • Gao Y, Ren C, Li X, Yu W, Li S, Li H, Wang Y, Li D, Ren M, Ji X. Ischemic Conditioning Ameliorated Hypertension and Vascular Remodeling of Spontaneously Hypertensive Rat via Inflammatory Regulation. Aging Dis. 2021 Feb 1;12(1):116-131. doi: 10.14336/AD.2020.0320. eCollection 2021 Feb.

    PMID: 33532132BACKGROUND

  • Tong XZ, Cui WF, Li Y, Su C, Shao YJ, Liang JW, Zhou ZT, Zhang CJ, Zhang JN, Zhang XY, Xia WH, Tao J. Chronic remote ischemic preconditioning-induced increase of circulating hSDF-1alpha level and its relation with reduction of blood pressure and protection endothelial function in hypertension. J Hum Hypertens. 2019 Dec;33(12):856-862. doi: 10.1038/s41371-018-0151-1. Epub 2019 Jan 10.

    PMID: 30631131BACKGROUND

  • Madias JE. Sustained blood pressure lowering effect of twice daily remote ischemic conditioning sessions in a normotensive/prehypertensive subject. Int J Cardiol. 2015 Mar 1;182:392-4. doi: 10.1016/j.ijcard.2014.12.159. Epub 2015 Jan 3. No abstract available.

    PMID: 25596469BACKGROUND

  • Guo W, Zhao W, Li D, Jia H, Ren C, Li S, Zhao J, Yu B, Dong J, Guo R, Zhu K, Cao Y, Wang Y, Wang Y, Li Z, Wang Z, Wang D, Hou C, Hausenloy DJ, Chu X, Ji X. Chronic Remote Ischemic Conditioning on Mild Hypertension in the Absence of Antihypertensive Medication: A Multicenter, Randomized, Double-Blind, Proof-of-Concept Clinical Trial. Hypertension. 2023 Jun;80(6):1274-1282. doi: 10.1161/HYPERTENSIONAHA.122.20934. Epub 2023 Apr 10.

    PMID: 37035920DERIVED

MeSH Terms

Conditions

Essential HypertensionPrehypertension

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Xunming Ji

    Xuanwu Hospital, Beijing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 1, 2021

First Posted

June 7, 2021

Study Start

June 15, 2021

Primary Completion

June 10, 2022

Study Completion

August 1, 2022

Last Updated

November 10, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(3)