NCT03945305

Brief Summary

The purpose of this study is to explore the efficacy and safety of remote ischemic conditioning for essential hypertension in the community population.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

May 8, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 10, 2019

Completed
4.5 years until next milestone

Study Start

First participant enrolled

November 25, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Completed
Last Updated

July 28, 2026

Status Verified

July 1, 2026

Enrollment Period

2.7 years

First QC Date

May 8, 2019

Last Update Submit

July 26, 2026

Conditions

Keywords

Essential Hypertension, Remote Ischemic Conditioning

Outcome Measures

Primary Outcomes (1)

  • Changes of mean systolic blood pressure

    The mean systolic blood pressure in the last 3 days of treatment minus baseline mean systolic blood pressure

    12-14 days

Secondary Outcomes (4)

  • Mean systolic blood pressure level

    12-14 days

  • Changes of mean diastolic blood pressure

    12-14 days

  • Mean diastolic blood pressure level

    12-14 days

  • Blood pressure target achievement rate

    14 days

Study Arms (2)

RIC group

ACTIVE COMPARATOR

Patients are treated with previous antihypertensive treatment plus remote ischemic conditioning.

Device: Patients are treated with previous antihypertensive treatment plus remote ischemic conditioning.

Control group

OTHER

Patients are only treated with previous antihypertensive treatment.

Other: Previous antihypertensive treatment

Interventions

Patients are only treated with previous antihypertensive treatment.

Control group

Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mmHg.

RIC group

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age≥30 years, ≤ 75 years, regardless of sex;
  • Patients with a history of essential hypertension and systolic blood pressure (SBP) ≥140 mmHg in three blood pressure measurements performed on separate days within 3 days prior to enrollment.
  • Signed and dated informed consent is obtained.

You may not qualify if:

  • Blood pressure ≥ 180/110mmHg;
  • Planned adjustment of antihypertensive drugs within the next 3 weeks;
  • Severe hematologic disorders or significant coagulation abnormalities;
  • Individuals who had contraindication of remote ischemic conditioning, such as severe soft tissue injury, fracture or vascular injury in the upper limb, acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc;
  • Pregnant or lactating women;
  • Severe hepatic and renal dysfunction;
  • Patients being enrolled or having been enrolled in another clinical trial within the 3 months prior to this clinical trial;
  • Patients unsuitable for enrollment in the clinical trial according to the investigator's discretion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Hospital of Jilin University

Changchun, Jilin, 130000, China

RECRUITING

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Central Study Contacts

Zhen-Ni Guo, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associated Dean of First Hospital of Jilin University

Study Record Dates

First Submitted

May 8, 2019

First Posted

May 10, 2019

Study Start

November 25, 2023

Primary Completion

July 31, 2026

Study Completion

July 31, 2026

Last Updated

July 28, 2026

Record last verified: 2026-07

Locations