Essential HypertensionNCT05845905
Effects of Remote Ischemic Conditioning on Blood Pressure in Older Patients With Hypertension
A study testing Remote ischemic conditioning in people with Essential Hypertension, run by Yi Yang at 1 site in China.
Trial summary
The purpose of this study is to learn about effects of remote ischemic conditioning on blood pressure in older patients with essential hypertension. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- Remote ischemic conditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2023to 31 Dec 2024
- 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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 1) Age ≥65 years and ≤85 years, regardless of gender;
- 2) History of essential hypertension and clinical systolic blood pressure ≥ 140 mmHg, regardless of whether they are receiving antihypertensive medication;
- 3) Willing to participate and sign the informed consent.
Who cannot join
- 1) Secondary hypertension;
- 2) Clinical blood pressure ≥ 180/110 mmHg or 24-hour mean arterial pressure ≥ 170/100 mmHg;
- 3) Severe organ dysfunction or failure;
- 4) Severe hematologic disorders or significant coagulation abnormalities;
- 5) History of atrial fibrillation or myocardial infarction within 6 months;
- 6) 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;
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- 7) Individuals who will or have received anticoagulant therapy with drugs such as dabigatran, rivaroxaban, warfarin, etc;
- 8) Those who are participating in other clinical research or has participated in other clinical research or has participated in this study within 3 months prior to enrollment;
- 9) Other conditions that the researchers think are not suitable for the project.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Hospital of Jilin University
Changchun, Jilin, 130000
Yi Yang, MD, PhD, 13756661217 ext. 0086, doctoryangyi@163.com
About this study
The purpose of this study is to learn about effects of remote ischemic conditioning on blood pressure in older patients with essential hypertension.
Read the detailed description
Current studies have shown that remote ischemic conditioning can improve vascular endothelial function and inhibit sympathetic nervous system activity. Thus it may provide some organ protection as well as anti-hypertensive effects. The purpose of this study is to learn about effects of remote ischemic conditioning on blood pressure in older patients with essential hypertension.
- Conditions
- Essential Hypertension
- Being tested
- Remote ischemic conditioning, Sham remote ischemic conditioning
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic conditioningProcedure or surgery
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 the inflation of an automated cuff to the pressure rising by 20 mmHg from baseline systolic pressure. RIC will be conducted twice daily for 7 days.
Sham remote ischemic conditioningProcedure or surgery
Sham-RIC is performed in the same way as the treatment group except that the blood pressure cuff is inflated to 60 mmHg, which produces mild pressure sensations but has no blocking impact on blood flow.
| Study group | Role | What they receive |
|---|---|---|
| RIC group | Active comparator | Patients are treated with remote ischemic conditioning (RIC). Receives: Procedure: Remote ischemic conditioning |
| Sham RIC group | Placebo comparator | Patients are treated with sham remote ischemic conditioning (sham-RIC). Receives: Procedure: Sham remote ischemic conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean systolic blood pressure
Difference in mean value of systolic blood pressure during RIC/sham-RIC between two groups.
Measured: 0-7 days
Secondary outcomes (1)
Mean diastolic blood pressure
Difference in mean value of diastolic blood pressure during RIC/sham-RIC between two groups.
Measured: 0-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start10 May 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yi Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yi Yang, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05845905
- Sponsor's protocol ID
- RICBP-HT
- Status last verified
- Oct 2024
- First submitted
- 13 Apr 2023
- Last updated
- 2 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Remote Ischemic Conditioning on Blood Pressure in Older Patients With Hypertension
- ClinicalTrials.gov ID
- NCT05845905
- Acronym / sponsor ID
- RICBP-HT
- Conditions
- Essential Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Yi YangUniversity, hospital or other
- Study start
- 10 May 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 May 2023 (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.
The purpose of this study is to learn about effects of remote ischemic conditioning on blood pressure in older patients with essential hypertension.
Detailed description
Current studies have shown that remote ischemic conditioning can improve vascular endothelial function and inhibit sympathetic nervous system activity. Thus it may provide some organ protection as well as anti-hypertensive effects. The purpose of this study is to learn about effects of remote ischemic conditioning on blood pressure in older patients with essential hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIC group | Active comparator | Procedure: Remote ischemic conditioningPatients are treated with remote ischemic conditioning (RIC). |
| Sham RIC group | Placebo comparator | Procedure: Sham remote ischemic conditioningPatients are treated with sham remote ischemic conditioning (sham-RIC). |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 1) Age ≥65 years and ≤85 years, regardless of gender;
- 2) History of essential hypertension and clinical systolic blood pressure ≥ 140 mmHg, regardless of whether they are receiving antihypertensive medication;
- 3) Willing to participate and sign the informed consent.
Key exclusion criteria (9 listed)
- 1) Secondary hypertension;
- 2) Clinical blood pressure ≥ 180/110 mmHg or 24-hour mean arterial pressure ≥ 170/100 mmHg;
- 3) Severe organ dysfunction or failure;
- 4) Severe hematologic disorders or significant coagulation abnormalities;
- 5) History of atrial fibrillation or myocardial infarction within 6 months;
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 |
|---|---|---|
| Remote ischemic conditioningRemote 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 the inflation of an automated cuff to the pressure rising by 20 mmHg from baseline systolic pressure. RIC will be conducted twice daily for 7 days. | Procedure or surgery | RIC group |
| Sham remote ischemic conditioningSham-RIC is performed in the same way as the treatment group except that the blood pressure cuff is inflated to 60 mmHg, which produces mild pressure sensations but has no blocking impact on blood flow. | Procedure or surgery | Sham RIC group |
Primary outcome
Mean systolic blood pressure
Time frame: 0-7 days
Difference in mean value of systolic blood pressure during RIC/sham-RIC between two groups.
1 secondary outcome
Mean diastolic blood pressure
Time frame: 0-7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote ischemic conditioning in people with Essential Hypertension, run by Yi Yang at 1 site 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 3 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: status not confirmed, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Yang, MD, PhD (13756661217 ext. 0086, doctor_yangyi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean systolic blood pressure (time frame: 0-7 days). 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 2 Oct 2024.