Safety and Efficacy of Remote Ischemic Conditioning Treatment for Community-based Essential Hypertension
1 other identifier
interventional
500
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2019
CompletedFirst Posted
Study publicly available on registry
May 10, 2019
CompletedStudy Start
First participant enrolled
November 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 28, 2024
CompletedFebruary 28, 2024
February 1, 2024
5 months
May 8, 2019
February 26, 2024
Conditions
Keywords
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 compliance rate
15-28 days
Study Arms (2)
RIC group
ACTIVE COMPARATORPatients are treated with previous antihypertensive treatment plus remote ischemic conditioning.
Control group
OTHERPatients are only treated with previous antihypertensive treatment.
Interventions
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.
Patients are only treated with previous antihypertensive treatment.
Eligibility Criteria
You may qualify if:
- Age≥40 years, ≤ 75 years, regardless of sex;
- Having the history of essential hypertension and the systolic blood pressure of at least 140 mm Hg on two consective days;
- Signed and dated informed consent is obtained
You may not qualify if:
- Blood pressure ≥ 180/110mmHg;
- Planned adjustment of antihypertensive drugs in the next month;
- 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, or ALT/AST \>3 times upper limit of normal, or serum creatinine \>265umol/l (\>3mg/dl);
- 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
- Yi Yanglead
Study Sites (1)
First Hospital of Jilin University
Changchun, Jilin, 130000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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 1, 2023
Primary Completion
March 31, 2024
Study Completion
April 28, 2024
Last Updated
February 28, 2024
Record last verified: 2024-02