Resistant HypertensionNCT05426707
Remote Ischemic Conditioning for the Treatment of Resistant Hypertension
A study testing RIC in people with Resistant Hypertension, run by Ji Xunming,MD,PhD.
Trial summary
This study aims to explore the efficacy and safety of remote ischemia adaptation for the treatment of resistant hypertension. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Resistant Hypertension
- What is being tested?
- RIC
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 30 Mar 2023
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 30~80 years old;
- Taking ≥ 3 antihypertensive drugs (including one diuretic) for more than 4 weeks regularly;
- Office blood pressure ≥ 140/90mmhg, and 24 h average blood pressure ≥ 130/80 mmHg;
- Willing to participate in the study, follow the study protocol, and provide informed consent.
Who cannot join
- Secondary hypertension;
- eGFR<45ml/min/1.73m2；
- Office blood pressure ≥180/110 mmHg, and 24 h average blood pressure ≥ 170/100 mmHg；
- Hypertensive crisis occurred within 3 months;
- Type 1 diabetes;
- Cardiovascular events occurred within 3 months;
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- Atrial fibrillation;
- Presence of any severe disease that adversely affects the subject or study;
- Patients with contraindication for remote ischemic conditioning, such as vascular injury, soft tissue injury, orthopedic injury, or arm infection;
- Pregnancy, lactation, or planned pregnancy;
- Patients not suitable for this trial considered by researchers for other reasons；
- Participation in another device or drug trial simultaneously.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy and Safety of Remote Ischemic Conditioning for the Treatment of Resistant Hypertension: a Pilot Study
This study aims to explore the efficacy and safety of remote ischemia adaptation for the treatment of resistant hypertension.
Read the detailed description
Resistant hypertension is defined as a blood pressure of 140/90 mmHg or higher despite adherence to at least three antihypertensive drugs (including one diuretic), accounting for 20% to 30% of patients with hypertension. Compared with patients with well-controlled blood pressure, the cardiovascular risk of resistant hypertension is increased by about 50%. Limb remote ischemic conditioning (LRIC) triggers endogenous protective effects through transient and repeated ischemia in the limb to protect remote tissues and organs. The mechanisms of LRIC involve the regulation of the autonomic nervous system, the 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 to a drop in BP theoretically. This theory has been preliminarily confirmed by several small sample-size studies in non-resistant hypertension. This study aims to explore the efficacy and safety of remote ischemia adaptation for the treatment of resistant hypertension.
- Conditions
- Resistant Hypertension
- Being tested
- RIC, Sham-RIC
- Keywords
- Resistant Hypertension, Remote ischemic conditioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RICDevice
RIC is a non-invasive therapy that is performed by automated pneumatic cuffs placed on bilateral arms. The RIC protocol includes five cycles of 5-min inflation to 200mmHg and 5-min deflation.
Sham-RICDevice
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 group | Role | What they receive |
|---|---|---|
| RIC group | Experimental | RIC is a non-invasive therapy that is performed by automated pneumatic cuffs placed on bilateral arms. The RIC protocol includes five cycles of 5-min inflation to 200mmHg and 5-min deflation. Receives: Device: RIC |
| Sham RIC group | Sham comparator | 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. Receives: Device: Sham-RIC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of 24 h average systolic blood pressure
Changes of 24 h average systolic blood pressure from baseline to 8 weeks
Measured: from baseline to 8 weeks
Secondary outcomes (10)
Changes of 24 h average diasolic blood pressure
Changes of 24 h average diasolic blood pressure from baseline to 8 weeks
Measured: from baseline to 8 weeks
Changes of daytime average systolic blood pressure
Changes of daytime average systolic blood pressure from baseline to 8 weeks
Measured: from baseline to 8 weeks
Changes of daytime average diastolic blood pressure
Changes of daytime average diastolic blood pressure from baseline to 8 weeks
Measured: from baseline to 8 weeks
Changes of nighttime average systolic blood pressure
Changes of nighttime average systolic blood pressure from baseline to 8 weeks
Measured: from baseline to 8 weeks
Changes of nighttime average diastolic blood pressure
Changes of nighttime average diastolic blood pressure from baseline to 8 weeks
Measured: from baseline to 8 weeks
Changes of 24 h average heart rate
Changes of 24 h average heart rate from baseline to 8 weeks
Measured: from baseline to 8 weeks
Changes of office systolic blood pressure
Changes of office systolic blood pressure from baseline to 8 weeks
Measured: from baseline to 8 weeks
Changes of office diastolic blood pressure
Changes of office diastolic blood pressure from baseline to 8 weeks
Measured: from baseline to 8 weeks
Changes of home systolic blood pressure
Changes of home systolic blood pressure from baseline to 8 weeks
Measured: from baseline to 8 weeks
Changes of home diastolic blood pressure
Changes of home diastolic blood pressure from baseline to 8 weeks
Measured: from baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start1 Oct 2022 (estimated)
- Primary completion1 Feb 2023 (estimated)
- Study completion30 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistant HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ji Xunming,MD,PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ji Xunming,MD,PhD, Capital Medical University
- Investigators
- Xunming Ji, MD, PhD, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05426707
- Sponsor's protocol ID
- RIC-Resistant HTN
- Status last verified
- Sep 2022
- First submitted
- 16 Jun 2022
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Remote Ischemic Conditioning for the Treatment of Resistant Hypertension: a Pilot Study
- ClinicalTrials.gov ID
- NCT05426707
- Acronym / sponsor ID
- RIC-Resistant HTN
- Conditions
- Resistant Hypertension
- Keywords
- Resistant Hypertension, Remote ischemic conditioning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ji Xunming,MD,PhDUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 22 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to explore the efficacy and safety of remote ischemia adaptation for the treatment of resistant hypertension.
Detailed description
Resistant hypertension is defined as a blood pressure of 140/90 mmHg or higher despite adherence to at least three antihypertensive drugs (including one diuretic), accounting for 20% to 30% of patients with hypertension. Compared with patients with well-controlled blood pressure, the cardiovascular risk of resistant hypertension is increased by about 50%. Limb remote ischemic conditioning (LRIC) triggers endogenous protective effects through transient and repeated ischemia in the limb to protect remote tissues and organs. The mechanisms of LRIC involve the regulation of the autonomic nervous system, the 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 to a drop in BP theoretically. This theory has been preliminarily confirmed by several small sample-size studies in non-resistant hypertension. This study aims to explore the efficacy and safety of remote ischemia adaptation for the treatment of resistant hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIC group | Experimental | Device: RICRIC is a non-invasive therapy that is performed by automated pneumatic cuffs placed on bilateral arms. The RIC protocol includes five cycles of 5-min inflation to 200mmHg and 5-min deflation. |
| Sham RIC group | Sham comparator | Device: Sham-RICThe 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. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 30~80 years old;
Key exclusion criteria (12 listed)
- Secondary hypertension;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RICRIC is a non-invasive therapy that is performed by automated pneumatic cuffs placed on bilateral arms. The RIC protocol includes five cycles of 5-min inflation to 200mmHg and 5-min deflation. | Device | RIC group |
| Sham-RICThe 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. | Device | Sham RIC group |
Primary outcome
Changes of 24 h average systolic blood pressure
Time frame: from baseline to 8 weeks
Changes of 24 h average systolic blood pressure from baseline to 8 weeks
10 secondary outcomes
Changes of 24 h average diasolic blood pressure
Time frame: from baseline to 8 weeks
Changes of daytime average systolic blood pressure
Time frame: from baseline to 8 weeks
Changes of daytime average diastolic blood pressure
Time frame: from baseline to 8 weeks
Changes of nighttime average systolic blood pressure
Time frame: from baseline to 8 weeks
Changes of nighttime average diastolic blood pressure
Time frame: from baseline to 8 weeks
Changes of 24 h average heart rate
Time frame: from baseline to 8 weeks
Changes of office systolic blood pressure
Time frame: from baseline to 8 weeks
Changes of office diastolic blood pressure
Time frame: from baseline to 8 weeks
Changes of home systolic blood pressure
Time frame: from baseline to 8 weeks
Changes of home diastolic blood pressure
Time frame: from baseline to 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xunming Ji, MD, PhD principal investigator
Xuanwu Hospital, Beijing
Questions about this trial
What is this clinical trial studying?
A study testing RIC in people with Resistant Hypertension, run by Ji Xunming,MD,PhD.
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 4 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xunming Ji, MD, PhD (83199430, jixm@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of 24 h average systolic blood pressure (time frame: from baseline to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2022.