The Antihypertensive Effect of Remote Ischemic Conditioning (RIC-HTN).

Sponsor

Capital Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04915313

Collaborator

Peking University Care Health Management Center (Other), The 306 Hospital of People's Liberation Army (Other)

Enrollment

Locations

Arms

12.5

Anticipated Duration (Months)

30.7

Patients Per Site

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study intends to further reveal the antihypertensive effect of LRIC and explore its potential mechanisms.

Condition or Disease	Intervention/Treatment	Phase
Hypertension,Essential Prehypertension	Device: Remote ischemic conditioning (RIC) Device: Sham remote ischemic conditioning (Sham-RIC)	N/A

Detailed Description

Stroke is the second-leading cause of death in the world and the leading cause of death in China. The estimated lifetime risk of stroke for those aged 25 years old and above is 24.9% worldwide and 39.3% in China. Hypertension is one of the main independent risk factors for stroke. Studies have shown that the risk of stroke increase at blood pressure (BP) above 115/75mmHg, each increase of 20mmHg in systolic blood pressure (SBP) or 10 mmHg in diastolic blood pressure (DBP) will double the risk of stroke. For those hypertensive patients without complications, each reduction of 10mmHg in SBP reduces approximately 17% risk of stroke, and each reduction of 5mmHg in DBP reduces 20%. Therefore, enhancing the primary prevention of stroke in hypertensive patients without vascular complications is important to reduce the burden of stroke in the future. However, these patients do not pay enough attention to their elevated BP and have poor compliance with antihypertensive drugs. Therefore, it is necessary to explore an economical, convenient and effective non-pharmacological therapy to control BP in order to reduce the risk of stroke.

Limb remote ischemic conditioning (LRIC) triggers endogenous protective effect through transient and repeated ischemia in the limb to protect remote tissues and organs. The mechanisms of LRIC involve the regulation of autonomic nervous system, release of humoral factors, improvement of vascular endothelial function and modulation of immune/inflammatory responses, which can antagonize the pathogenesis of hypertension through multiple pathways to lead a drop in BP theoretically. This theory has been preliminarily confirmed by several small sample-size studies. Therefore, this study intends to conduct a randomized controlled trial to further reveal the antihypertensive effect of LRIC and explore its potential mechanisms.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

92 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Antihypertensive Effect of Remote Ischemic Conditioning: A Multicenter, Randomized, Double-blind, Sham-controlled Trial.

Actual Study Start Date :

Jun 15, 2021

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group Subjects in the intervention group will recieve remote ischemic conditioning (RIC) treatment twice a day for 4 weeks.	Device: Remote ischemic conditioning (RIC) RIC is a non-invasive therapy which is performed by automated pneumatic cuffs placed on bilateral arms. The RIC protocol include five cycles of 5-min inflation to 200mmHg and 5-min deflation.
Sham Comparator: Sham control group Subject in the sham control group will recieve sham remote ischemic conditioning (Sham-RIC) treatment twice a day for 4 weeks..	Device: Sham remote ischemic conditioning (Sham-RIC) The Sham-RIC protocol include five cycles of 5-min inflation to 60 mmHg and 5-min deflation by placing automated pneumatic cuffs on bilateral arms.

Arm

Intervention/Treatment

Experimental: Intervention group

Subjects in the intervention group will recieve remote ischemic conditioning (RIC) treatment twice a day for 4 weeks.

Device: Remote ischemic conditioning (RIC)

RIC is a non-invasive therapy which is performed by automated pneumatic cuffs placed on bilateral arms. The RIC protocol include five cycles of 5-min inflation to 200mmHg and 5-min deflation.

Sham Comparator: Sham control group

Subject in the sham control group will recieve sham remote ischemic conditioning (Sham-RIC) treatment twice a day for 4 weeks..

Device: Sham remote ischemic conditioning (Sham-RIC)

The Sham-RIC protocol include five cycles of 5-min inflation to 60 mmHg and 5-min deflation by placing automated pneumatic cuffs on bilateral arms.

Outcome Measures

Primary Outcome Measures

Changes of average 24-h ambulatory systolic blood pressure. [From baseline to 4 weeks.]
Changes of average 24-h ambulatory systolic blood pressure from baseline to four weeks.

Secondary Outcome Measures

Changes of average 24-h ambulatory diastolic blood pressure. [From baseline to 4 weeks.]
Changes of average 24-h ambulatory diastolic blood pressure from baseline to four weeks.
Changes of average daytime ambulatory systolic blood pressure. [From baseline to 4 weeks.]
Changes of average daytime ambulatory systolic blood pressure from baseline to four weeks.
Changes of average daytime ambulatory diastolic blood pressure. [From baseline to 4 weeks.]
Changes of average daytime ambulatory diastolic blood pressure from baseline to four weeks.
Changes of average night-time ambulatory systolic blood pressure. [From baseline to 4 weeks.]
Changes of average night-time ambulatory systolic blood pressure from baseline to four weeks.
Changes of average night-time ambulatory diastolic blood pressure. [From baseline to 4 weeks.]
Changes of average night-time ambulatory diastolic blood pressure from baseline to four weeks.
Changes of average 24-h heart rate. [From baseline to 4 weeks.]
Changes of average 24-h heart rate from baseline to four weeks.
Proportion of patients with average 24-h ambulatory systolic blood pressure reduction more than 5 mmHg. [From baseline to 4 weeks.]
Proportion of patients with average 24-h ambulatory systolic blood pressure reduction more than 5 mmHg.
Changes of office systolic blood pressure. [From baseline to 4 weeks.]
Changes of office systolic blood pressure from baseline to four weeks.
Changes of office diastolic blood pressure. [From baseline to 4 weeks.]
Changes of office diastolic blood pressure from baseline to four weeks.
Changes of vascular endothelium function(flow-mediated dilation , FMD) or arterial Stiffness(brachial-ankle pulse wave velocity, ba-PWV). [From baseline to 4 weeks.]
Changes of FMD or ba-PWV from baseline to four weeks.
Changes of blood biomarkers. [From baseline to 4 weeks.]
Changes of blood biomarkers which have been demonstrated to correlate with hypertension, such as NO、ET-1、IL-10、TNF-α、IL-1β、SDF-1α, from baseline to four weeks.
Adverse events related or not related to RIC treatment. [From baseline to 4 weeks.]
Adverse events related to RIC treatment, such as local edema, erythema, skin lesions of the arms, or adverse events not related to RIC treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Aged 50-80 years；
Office blood pressure ≥130/80mmHg and<160/100mmHg; and 24-h ambulatory systolic/diastolic blood pressure ≥125/75mmHg;
Never taking antihypertensive drugs or have stopped taking antihypertensive drugs for more than one month;
Do not receive any antihypertensive drugs during the research;
Informed consent obtained from the subjects or their legally authorized representative.

Exclusion Criteria:

Secondary hypertension;
Patients who are taking antihypertensive drugs regularly;
Patients with contraindication for remote ischemic conditioning, such as vascular injury, soft tissue injury, orthopedic injury, or arm infection;
Patients with bleeding disorder;
Patients with atrial fibrillation or other severe arrhythmias；
Patients with prior myocardial infarction or stroke；
Patients with serious or unstable medical condition, such as severe liver or kidney dysfunction, heart failure, respiratory failure, malignant tumors, or autoimmune diseases;
Participation in another device or drug trial simultaneously;
Patients who are not suitable for this trial considered by researchers for other reasons.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xuanwu Hospital, Capital Medical University	Beijing	Beijing	China	100053
2	Peking University Care Health Management Center	Beijing	Beijing	China	100080
3	The 306 Hospital of People's Liberation Army	Beijing	Beijing	China	100101