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NCT Number: NCT03945305

Safety and Efficacy of Remote Ischemic Conditioning Treatment for Community-based Essential Hypertension

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

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Key information

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Hospital of Jilin University

Changchun, Jilin, 130000, China

Location status: Recruiting

Location contact

Yi Yang, MD, PhD

CONTACT

[email protected]

About this study

At present, stroke has become the leading cause of death in China, with hypertension being the primary risk factor and one of the controllable risk factors. Current studies have shown that remote ischemic conditioning can improve vascular endothelial function, inhibit sympathetic nervous system activity and regulate immune and inflammatory reactions. Thus it may exert anti-hypertensive effects through multiple mechanisms. The purpose of this study is to investigate the efficacy and safety of remote ischemic conditioning for essential hypertension in the community population.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

Device

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.

Previous antihypertensive treatment

Other

Patients are only treated with previous antihypertensive treatment.

Primary outcomes

  1. Changes of mean systolic blood pressure

    Time frame: 12-14 days

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

Secondary outcomes

  1. Mean systolic blood pressure level

    Time frame: 12-14 days

    Mean systolic blood pressure levels during the last 3 days of treatment

  2. Changes of mean diastolic blood pressure

    Time frame: 12-14 days

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

  3. Mean diastolic blood pressure level

    Time frame: 12-14 days

    Mean diastolic blood pressure levels during the last 3 days of treatment

  4. Blood pressure target achievement rate

    Time frame: 14 days

    Blood pressure target achievement rate after treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Yi Yang, MD,PhD

CONTACT

[email protected]

0086-13756661217

Zhen-Ni Guo, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Yi Yang

Other

Registry information

Official study title

Safety and Efficacy of Remote Ischemic Conditioning Treatment for Community-based Essential Hypertension: a Randomized, Parallel-controlled Clinical Trial

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 10, 2019
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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