Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04915313
Other study ID # RIC-HTN
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 15, 2021
Est. completion date August 1, 2022

Study information

Verified date November 2022
Source Capital Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 95
Est. completion date August 1, 2022
Est. primary completion date June 10, 2022
Accepts healthy volunteers No
Gender All
Age group 50 Years to 80 Years
Eligibility Inclusion Criteria: 1. Aged 50-80 years; 2. Office blood pressure =130/80mmHg and<160/100mmHg; and 24-h ambulatory systolic/diastolic blood pressure =125/75mmHg; 3. Never taking antihypertensive drugs or have stopped taking antihypertensive drugs for more than one month; 4. Do not receive any antihypertensive drugs during the research; 5. Informed consent obtained from the subjects or their legally authorized representative. Exclusion Criteria: 1. Secondary hypertension; 2. Patients who are taking antihypertensive drugs regularly; 3. Patients with contraindication for remote ischemic conditioning, such as vascular injury, soft tissue injury, orthopedic injury, or arm infection; 4. Patients with bleeding disorder; 5. Patients with atrial fibrillation or other severe arrhythmias; 6. Patients with prior myocardial infarction or stroke; 7. Patients with serious or unstable medical condition, such as severe liver or kidney dysfunction, heart failure, respiratory failure, malignant tumors, or autoimmune diseases; 8. Participation in another device or drug trial simultaneously; 9. Patients who are not suitable for this trial considered by researchers for other reasons.

Study Design


Intervention

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 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.

Locations

Country Name City State
China Peking University Care Health Management Center Beijing Beijing
China The 306 Hospital of People's Liberation Army Beijing Beijing
China Xuanwu Hospital, Capital Medical University Beijing Beijing

Sponsors (3)

Lead Sponsor Collaborator
Capital Medical University Peking University Care Health Management Center, The 306 Hospital of People's Liberation Army

Country where clinical trial is conducted

China, 

References & Publications (3)

Gao Y, Ren C, Li X, Yu W, Li S, Li H, Wang Y, Li D, Ren M, Ji X. Ischemic Conditioning Ameliorated Hypertension and Vascular Remodeling of Spontaneously Hypertensive Rat via Inflammatory Regulation. Aging Dis. 2021 Feb 1;12(1):116-131. doi: 10.14336/AD.2020.0320. eCollection 2021 Feb. — View Citation

Madias JE. Sustained blood pressure lowering effect of twice daily remote ischemic conditioning sessions in a normotensive/prehypertensive subject. Int J Cardiol. 2015 Mar 1;182:392-4. doi: 10.1016/j.ijcard.2014.12.159. Epub 2015 Jan 3. — View Citation

Tong XZ, Cui WF, Li Y, Su C, Shao YJ, Liang JW, Zhou ZT, Zhang CJ, Zhang JN, Zhang XY, Xia WH, Tao J. Chronic remote ischemic preconditioning-induced increase of circulating hSDF-1a level and its relation with reduction of blood pressure and protection endothelial function in hypertension. J Hum Hypertens. 2019 Dec;33(12):856-862. doi: 10.1038/s41371-018-0151-1. Epub 2019 Jan 10. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Changes of average 24-h ambulatory systolic blood pressure. Changes of average 24-h ambulatory systolic blood pressure from baseline to four weeks. From baseline to 4 weeks.
Secondary Changes of average 24-h ambulatory diastolic blood pressure. Changes of average 24-h ambulatory diastolic blood pressure from baseline to four weeks. From baseline to 4 weeks.
Secondary Changes of average daytime ambulatory systolic blood pressure. Changes of average daytime ambulatory systolic blood pressure from baseline to four weeks. From baseline to 4 weeks.
Secondary Changes of average daytime ambulatory diastolic blood pressure. Changes of average daytime ambulatory diastolic blood pressure from baseline to four weeks. From baseline to 4 weeks.
Secondary Changes of average night-time ambulatory systolic blood pressure. Changes of average night-time ambulatory systolic blood pressure from baseline to four weeks. From baseline to 4 weeks.
Secondary Changes of average night-time ambulatory diastolic blood pressure. Changes of average night-time ambulatory diastolic blood pressure from baseline to four weeks. From baseline to 4 weeks.
Secondary Changes of average 24-h heart rate. Changes of average 24-h heart rate from baseline to four weeks. From baseline to 4 weeks.
Secondary Proportion of patients with average 24-h ambulatory systolic blood pressure reduction more than 5 mmHg. Proportion of patients with average 24-h ambulatory systolic blood pressure reduction more than 5 mmHg. From baseline to 4 weeks.
Secondary Changes of office systolic blood pressure. Changes of office systolic blood pressure from baseline to four weeks. From baseline to 4 weeks.
Secondary Changes of office diastolic blood pressure. Changes of office diastolic blood pressure from baseline to four weeks. From baseline to 4 weeks.
Secondary Changes of vascular endothelium function(flow-mediated dilation , FMD) or arterial Stiffness(brachial-ankle pulse wave velocity, ba-PWV). Changes of FMD or ba-PWV from baseline to four weeks. From baseline to 4 weeks.
Secondary Changes of blood biomarkers. Changes of blood biomarkers which have been demonstrated to correlate with hypertension, such as NO?ET-1?IL-10?TNF-a?IL-1ß?SDF-1a, from baseline to four weeks. From baseline to 4 weeks.
Secondary Adverse events related or not related to RIC treatment. Adverse events related to RIC treatment, such as local edema, erythema, skin lesions of the arms, or adverse events not related to RIC treatment. From baseline to 4 weeks.
See also
  Status Clinical Trial Phase
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Completed NCT02551640 - Improving Physical Activity Through a mHealth Intervention in Cardio-metabolic Risk Patients N/A
Recruiting NCT01483430 - Effect of Ginseol Kg1 on Blood Pressure Lowering Phase 3
Completed NCT01637909 - Korean Life-Style Modification Effects on Blood Pressure N/A
Terminated NCT01295216 - Use of Mobile Technology to Prevent Progression of Pre-hypertension in Latin American Urban Settings N/A
Unknown status NCT01308983 - Study of Amiloride on Vascular Phenotypes in Young Adults With Prehypertension Phase 4
Active, not recruiting NCT03596099 - Rice Vinegar as an Intervention to Lower Blood Pressure in Adults With Prehypertension and 10-year CVD Risk <10% N/A
Completed NCT04326686 - Measuring Individual Responses to a Wholegrains and Nuts Intervention to Reduce Blood Pressure in Prehypertension N/A
Completed NCT03898518 - The Effects of a Jump Rope Exercise Program on Body Composition and Self-efficacy in Obese Adolescent Girls N/A
Terminated NCT01983462 - Vascular Dysfunction in Human Obesity Hypertension Phase 2
Completed NCT01472692 - Study of Febuxostat Effect on Blood Pressure in Patients With High Normal Blood Pressure Phase 4
Completed NCT01458496 - Health Coaching to Effect Lifestyle Behaviour Change N/A
Completed NCT03266510 - Inspiratory Muscle Strength Training to Improve Blood Pressure and Physiological Function N/A
Completed NCT02998840 - A Prospective Study of B244 Delivered as a Topical Spray to Determine Safety and Efficacy in Subjects With Elevated Blood Pressure Phase 2
Completed NCT01974570 - Effect and Safety of Marealis RPC (Refined Peptide Concentrate) in Mild or Moderate Hypertensive Subjects Phase 2
Completed NCT02326766 - Blood Pressure Lowering Effect of Supplementation With Korea Red Ginseng Associated With Reductions in Circulating Lp-PLA2 Activity and Lysophospatidylcholines and an Increase in Dihydrobiopterin in Prehypertensive Subjects Phase 3
Completed NCT01395329 - Nebivolol and the Endothelin (ET)-1 System Phase 4
Completed NCT01331486 - Nitric Oxide Mediated Vasodilatory Response to Hawthorn Standardized Extract Phase 1
Completed NCT05274971 - Diet and Exercise on Ambulatory Blood Pressure N/A
Active, not recruiting NCT02371317 - Stress Management for High Blood Pressure N/A