AzTrials
AzTrials

Hypertension,EssentialNCT04915313

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

A study testing Remote ischemic conditioning (RIC) in people with Hypertension,Essential and Prehypertension, run by Capital Medical University at 3 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Hypertension,Essential, Prehypertension
What is being tested?
Remote ischemic conditioning (RIC)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
95 participants
Where
3 sitesChina
Study dates
15 Jun 2021to 1 Aug 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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；
Show all 9Show fewer
  • 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.

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Xuanwu Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100053

  • Peking University Care Health Management Center

    Beijing, Beijing Municipality, 100080

  • The 306 Hospital of People's Liberation Army

    Beijing, Beijing Municipality, 100101

Other trials in China

About this study

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

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

Read the 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.

Being tested
Remote ischemic conditioning (RIC), Sham remote ischemic conditioning (Sham-RIC)
Keywords
Remote ischemic conditioning, Essential hypertension, Prehypertension, Blood pressure
Medical subject headings
Essential Hypertension, Prehypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Remote ischemic conditioning (RIC)Device

    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)Device

    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.

Study groups in NCT04915313
Study groupRoleWhat they receive
Intervention groupExperimentalSubjects in the intervention group will recieve remote ischemic conditioning (RIC) treatment twice a day for 4 weeks.
Receives: Device: Remote ischemic conditioning (RIC)
Sham control groupSham comparatorSubject in the sham control group will recieve sham remote ischemic conditioning (Sham-RIC) treatment twice a day for 4 weeks..
Receives: Device: Sham remote ischemic conditioning (Sham-RIC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes of average 24-h ambulatory systolic blood pressure.

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

    Measured: From baseline to 4 weeks.

Secondary outcomes (12)

  1. Changes of average 24-h ambulatory diastolic blood pressure.

    Changes of average 24-h ambulatory diastolic blood pressure from baseline to four weeks.

    Measured: From baseline to 4 weeks.

  2. Changes of average daytime ambulatory systolic blood pressure.

    Changes of average daytime ambulatory systolic blood pressure from baseline to four weeks.

    Measured: From baseline to 4 weeks.

  3. Changes of average daytime ambulatory diastolic blood pressure.

    Changes of average daytime ambulatory diastolic blood pressure from baseline to four weeks.

    Measured: From baseline to 4 weeks.

  4. Changes of average night-time ambulatory systolic blood pressure.

    Changes of average night-time ambulatory systolic blood pressure from baseline to four weeks.

    Measured: From baseline to 4 weeks.

  5. Changes of average night-time ambulatory diastolic blood pressure.

    Changes of average night-time ambulatory diastolic blood pressure from baseline to four weeks.

    Measured: From baseline to 4 weeks.

  6. Changes of average 24-h heart rate.

    Changes of average 24-h heart rate from baseline to four weeks.

    Measured: From baseline to 4 weeks.

  7. 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.

    Measured: From baseline to 4 weeks.

  8. Changes of office systolic blood pressure.

    Changes of office systolic blood pressure from baseline to four weeks.

    Measured: From baseline to 4 weeks.

  9. Changes of office diastolic blood pressure.

    Changes of office diastolic blood pressure from baseline to four weeks.

    Measured: From baseline to 4 weeks.

  10. 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.

    Measured: From baseline to 4 weeks.

  11. Changes of blood biomarkers.

    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.

    Measured: From baseline to 4 weeks.

  12. 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.

    Measured: From baseline to 4 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2021
  2. Study start15 Jun 2021
  3. Primary completion10 Jun 2022
  4. Study completion1 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
95 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04915313
Sponsor's protocol ID
RIC-HTN
Status last verified
Nov 2022
First submitted
1 Jun 2021
Last updated
10 Nov 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33532132

  • 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-1alpha 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.

    PubMed 30631131

  • 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. No abstract available.

    PubMed 25596469

  • Guo W, Zhao W, Li D, Jia H, Ren C, Li S, Zhao J, Yu B, Dong J, Guo R, Zhu K, Cao Y, Wang Y, Wang Y, Li Z, Wang Z, Wang D, Hou C, Hausenloy DJ, Chu X, Ji X. Chronic Remote Ischemic Conditioning on Mild Hypertension in the Absence of Antihypertensive Medication: A Multicenter, Randomized, Double-Blind, Proof-of-Concept Clinical Trial. Hypertension. 2023 Jun;80(6):1274-1282. doi: 10.1161/HYPERTENSIONAHA.122.20934. Epub 2023 Apr 10.

    PubMed 37035920

Questions about this trial

What is this clinical trial studying?

A study testing Remote ischemic conditioning (RIC) in people with Hypertension,Essential and Prehypertension, run by Capital Medical University at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes of average 24-h ambulatory systolic blood pressure. (time frame: From baseline to 4 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04915313, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in