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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-75
SponsorYi Yang

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    Patients are only treated with previous antihypertensive treatment.

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: RIC groupActive comparator 1 intervention
Group B: Control groupOther 1 intervention

Trial outcomes

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

Time frame
12-14 days

Secondary outcomes

1

Mean systolic blood pressure level

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

Time frame
12-14 days
2

Changes of mean diastolic blood pressure

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

Time frame
12-14 days
3

Mean diastolic blood pressure level

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

Time frame
12-14 days
4

Blood pressure target achievement rate

Blood pressure target achievement rate after treatment

Time frame
14 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yi Yang

Lead sponsor

The First Hospital of Jilin University

Sponsor institution