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NCT Number: NCT05845905

Effects of Remote Ischemic Conditioning on Blood Pressure in Older Patients With Hypertension

The purpose of this study is to learn about effects of remote ischemic conditioning on blood pressure in older patients with essential hypertension.

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Key information

Age range

65 year–85 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]

13756661217 ext. 0086

About this study

Current studies have shown that remote ischemic conditioning can improve vascular endothelial function and inhibit sympathetic nervous system activity. Thus it may provide some organ protection as well as anti-hypertensive effects. The purpose of this study is to learn about effects of remote ischemic conditioning on blood pressure in older patients with essential hypertension.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 1) Age ≥65 years and ≤85 years, regardless of gender;
  • 2) History of essential hypertension and clinical systolic blood pressure ≥ 140 mmHg, regardless of whether they are receiving antihypertensive medication;
  • 3) Willing to participate and sign the informed consent.

Exclusion criteria

  • 1) Secondary hypertension;
  • 2) Clinical blood pressure ≥ 180/110 mmHg or 24-hour mean arterial pressure ≥ 170/100 mmHg;
  • 3) Severe organ dysfunction or failure;
  • 4) Severe hematologic disorders or significant coagulation abnormalities;
  • 5) History of atrial fibrillation or myocardial infarction within 6 months;
  • 6) 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;
  • 7) Individuals who will or have received anticoagulant therapy with drugs such as dabigatran, rivaroxaban, warfarin, etc;
  • 8) Those who are participating in other clinical research or has participated in other clinical research or has participated in this study within 3 months prior to enrollment;
  • 9) Other conditions that the researchers think are not suitable for the project.

Treatment and study plan

Remote Ischemic conditioning

Procedure

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 the inflation of an automated cuff to the pressure rising by 20 mmHg from baseline systolic pressure. RIC will be conducted twice daily for 7 days.

Sham remote ischemic conditioning

Procedure

Sham-RIC is performed in the same way as the treatment group except that the blood pressure cuff is inflated to 60 mmHg, which produces mild pressure sensations but has no blocking impact on blood flow.

Primary outcomes

  1. Mean systolic blood pressure

    Time frame: 0-7 days

    Difference in mean value of systolic blood pressure during RIC/sham-RIC between two groups.

Secondary outcomes

  1. Mean diastolic blood pressure

    Time frame: 0-7 days

    Difference in mean value of diastolic blood pressure during RIC/sham-RIC between two groups.

Study contacts

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

Yi Yang, MD, PhD

CONTACT

[email protected]

13756661217 ext. 0086

Zhen-Ni Guo, MD, PhD

CONTACT

[email protected]

18186872986 ext. 0086

Sponsors and collaborators

Lead sponsor

Yi Yang

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 6, 2023
Registry last updated
Oct 2, 2024

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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