HypertensionRIPCoNCT05971407
The Effect of Chronic Remote Ischaemic Preconditioning on Blood Pressure in Older Adults
A study testing Remote Ischaemic Preconditioning in people with Hypertension and Vascular Diseases, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
The purpose of this study is to assess whether remote ischaemic conditioning, applied chronically, improves vascular health in older adults Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Vascular Diseases
- What is being tested?
- Remote Ischaemic Preconditioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Sep 2022to 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Participant is aged >65y and <85y.
- Participant is willing and able to give informed consent for participation in the study.
- Participant is physically able to perform RIPC.
Who cannot join
- A BMI <18 or >35 kg/m2
- Active cardiovascular, cerebrovascular or respiratory disease: e.g. uncontrolled hypertension (BP > 160/100), active angina, heart failure (class III/IV), arrhythmia, right to left cardiac shunt, recent cardiac event, COPD, pulmonary hypertension or recent (6 mo) stroke.
- If history of hypertension, no recent alteration to antihypertensive medication (3 months).
- A history of, or current neurological or musculoskeletal conditions (e.g. epilepsy)
- Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
School of Medicine, Royal Derby Hospital Site, University of Nottingham
Derby, Derbyshire, DE22 3DT
About this study
The purpose of this study is to assess whether remote ischaemic conditioning, applied chronically, improves vascular health in older adults
Read the detailed description
Hypertension and stroke remain leading causes of mortality across the world (1). Hypertension affects more than 1 in 4 adults and is the 3rd biggest risk factor for premature death and disability in the UK (2). Cerebrovascular disease is ranked 4th in the list of leading causes of death in the UK (3). At present, the treatment of these conditions largely involves chronic pharmacotherapy. In parallel, it is increasingly appreciated that polypharmacy poses a significant challenge to our older adult population. Guthrie et al showed that the number of people prescribed >5 medications in an area of the UK doubled between 1995 and 2010 (from 11.4% to 20.8%) (4). Age is significantly associated with polypharmacy, with an odds ratio of 118.3 when those aged 20-29 are compared to those >80. What's more, it has been estimated that adverse drug reactions account for 6.5% of hospital admissions (5), with age correlating significantly with admissions for this reason. Therefore, discovering a non-pharmacological intervention for hypertension and cerebrovascular disease could greatly benefit the population, particularly the elderly, both in terms of treating the diseases themselves and reducing the harmful effects of polypharmacy.
Remote ischaemic preconditioning (RIPC) is the induction of non-lethal ischaemia in one organ or tissue, with the aim of conditioning a distant organ or tissue against ischaemic events. It is achieved via inflation of a blood pressure cuff to supra-systolic pressures for a short period of time. A recent meta-analysis showed that chronic RIC, but not acute RIC, significantly lowered diastolic and mean arterial blood pressure (6). The studies included in this review were small and performed in a younger population, hence larger studies are needed to clarify the effect of RIC in the field of hypertension and, importantly, the elderly.
- Conditions
- Hypertension, Vascular Diseases
- Being tested
- Remote Ischaemic Preconditioning, Sham Remote Ischaemic Preconditioning
- Keywords
- Remote Ischaemic Preconditioning, Non-pharmacological, Remote Ischaemic Conditioning, Randomised Controlled Trial
- Medical subject headings
- Hypertension, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Ischaemic PreconditioningDevice
RIPC is induced by 4 cycles of 5 minutes of healthy upper limb ischaemia followed by 5 minutes reperfusion. Ischaemia is induced by inflation of a blood pressure cuff to 20mmHg above systolic blood pressure. RIPC is conducted 3 times weekly for 6-weeks. Clinic blood pressure is measured at weeks 0, 3 and 6. 24-hour blood pressure is measured at weeks 0 and 6.
Sham Remote Ischaemic PreconditioningDevice
Sham RIPC is induced by 4 cycles of 5 minutes of healthy upper limb ischaemia followed by 5 minutes reperfusion. Ischaemia is induced by inflation of a blood pressure cuff to 20mmHg. RIPC is conducted 3 times weekly for 6-weeks. Clinic blood pressure is measured at weeks 0, 3 and 6. 24-hour blood pressure is measured at weeks 0 and 6.
| Study group | Role | What they receive |
|---|---|---|
| Remote Ischaemic Preconditioning | Active comparator | RIPC is induced by 4 cycles of 5 minutes of healthy upper limb ischaemia followed by 5 minutes reperfusion. Ischaemia is induced by inflation of a blood pressure cuff to 20mmHg above systolic blood pressure. RIPC is conducted 3 times weekly for 6-weeks. Receives: Device: Remote Ischaemic Preconditioning |
| Sham remote ischaemic preconditioning | Sham comparator | Sham RIPC is induced by 4 cycles of 5 minutes of healthy upper limb ischaemia followed by 5 minutes reperfusion. Ischaemia is induced by inflation of a blood pressure cuff to 20mmHg. RIPC is conducted 3 times weekly for 6-weeks Receives: Device: Sham Remote Ischaemic Preconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinic systolic blood pressure
Changes in blood pressure measured by automated sphygmomanometer over 6 weeks. Measured after participants have rested for 10 minutes in a temperature controlled room.
Measured: Measured at baseline, week 3 and week 6
Secondary outcomes (8)
Clinic diastolic blood pressure
Changes in blood pressure measured by automated sphygmomanometer over 6 weeks. Measured after participants have rested for 10 minutes in a temperature controlled room.
Measured: Measured at baseline, week 3 and week 6
Clinic Mean arterial pressure
Changes in blood pressure measured by automated sphygmomanometer over 6 weeks. Measured after participants have rested for 10 minutes in a temperature controlled room.
Measured: Measured at baseline, week 3 and week 6
24-hour systolic blood pressure
Changes in blood pressure measured by 24-hour blood pressure monitor.
Measured: Measured at baseline and week 6
24-hour diastolic blood pressure
Changes in blood pressure measured by 24-hour blood pressure monitor.
Measured: Measured at baseline and week 6
24-hour mean arterial pressure
Changes in blood pressure measured by 24-hour blood pressure monitor.
Measured: Measured at baseline and week 6
Flow mediated dilatation (FMD)
Flow mediated dilatation is measured by continuous ultrasound imaging of the brachial artery. Brachial artery diameter is measured using edge tracking software for one minute before distal occlusion is applied to the brachial artery for 5 minutes at 230mmHg using and automated vascular assessment pressure cuff. Following release of the distal occlusion, flow mediated dilatation is measured for 4 minutes using edge tracking software
Measured: Measured at baseline, week 3 and week 6
Pulsewave velocity (PWV)
Pulsewave velocity is measured using carotid and femoral artery transducers. Pulse transit time and the distance between transducers is then used to calculate PWV.
Measured: Measured at baseline, week 3 and week 6
Serum biomarkers
Biomarkers of RIC mechanism will be quantified by ELISA from plasma samples collected before and after intervention.
Measured: Measured at baseline and week 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start25 Sep 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- Participants complete a 6-week intervention period during which the participants receive either RIPC or sham. There is then a 6-week washout period, after which participants complete the other intervention
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bethan Phillips, University of Nottingham
- Investigators
- Timothy England, MB ChB PhD, Principal investigator, University of NottinghamBethan Phillips, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971407
- Sponsor's protocol ID
- FMHS 34-0722
- Acronym
- RIPCo
- Status last verified
- Apr 2025
- First submitted
- 4 Jul 2023
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Virani SS, Alonso A, Aparicio HJ, Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Cheng S, Delling FN, Elkind MSV, Evenson KR, Ferguson JF, Gupta DK, Khan SS, Kissela BM, Knutson KL, Lee CD, Lewis TT, Liu J, Loop MS, Lutsey PL, Ma J, Mackey J, Martin SS, Matchar DB, Mussolino ME, Navaneethan SD, Perak AM, Roth GA, Samad Z, Satou GM, Schroeder EB, Shah SH, Shay CM, Stokes A, VanWagner LB, Wang NY, Tsao CW; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2021 Update: A Report From the American Heart Association. Circulation. 2021 Feb 23;143(8):e254-e743. doi: 10.1161/CIR.0000000000000950. Epub 2021 Jan 27.
PubMed 33501848Health matters: combating high blood pressure: Public Health England; 2017
https://www.stroke.org.uk/what-is-stroke/stroke-statistics
Guthrie B, Makubate B, Hernandez-Santiago V, Dreischulte T. The rising tide of polypharmacy and drug-drug interactions: population database analysis 1995-2010. BMC Med. 2015 Apr 7;13:74. doi: 10.1186/s12916-015-0322-7.
PubMed 25889849Pirmohamed M, James S, Meakin S, Green C, Scott AK, Walley TJ, Farrar K, Park BK, Breckenridge AM. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. BMJ. 2004 Jul 3;329(7456):15-9. doi: 10.1136/bmj.329.7456.15.
PubMed 15231615Baffour-Awuah B, Dieberg G, Pearson MJ, Smart NA. The effect of remote ischaemic conditioning on blood pressure response: A systematic review and meta-analysis. Int J Cardiol Hypertens. 2021 Feb 23;8:100081. doi: 10.1016/j.ijchy.2021.100081. eCollection 2021 Mar.
PubMed 33748739
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chronic Remote Ischaemic Preconditioning on Blood Pressure in Older Adults
- ClinicalTrials.gov ID
- NCT05971407
- Acronym / sponsor ID
- RIPCo / FMHS 34-0722
- Conditions
- Hypertension, Vascular Diseases
- Keywords
- Remote Ischaemic Preconditioning, Non-pharmacological, Remote Ischaemic Conditioning, Randomised Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 25 Sep 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 2 Aug 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 assess whether remote ischaemic conditioning, applied chronically, improves vascular health in older adults
Detailed description
Hypertension and stroke remain leading causes of mortality across the world (1). Hypertension affects more than 1 in 4 adults and is the 3rd biggest risk factor for premature death and disability in the UK (2). Cerebrovascular disease is ranked 4th in the list of leading causes of death in the UK (3). At present, the treatment of these conditions largely involves chronic pharmacotherapy. In parallel, it is increasingly appreciated that polypharmacy poses a significant challenge to our older adult population. Guthrie et al showed that the number of people prescribed >5 medications in an area of the UK doubled between 1995 and 2010 (from 11.4% to 20.8%) (4). Age is significantly associated with polypharmacy, with an odds ratio of 118.3 when those aged 20-29 are compared to those >80. What's more, it has been estimated that adverse drug reactions account for 6.5% of hospital admissions (5), with age correlating significantly with admissions for this reason. Therefore, discovering a non-pharmacological intervention for hypertension and cerebrovascular disease could greatly benefit the population, particularly the elderly, both in terms of treating the diseases themselves and reducing the harmful effects of polypharmacy.
Remote ischaemic preconditioning (RIPC) is the induction of non-lethal ischaemia in one organ or tissue, with the aim of conditioning a distant organ or tissue against ischaemic events. It is achieved via inflation of a blood pressure cuff to supra-systolic pressures for a short period of time. A recent meta-analysis showed that chronic RIC, but not acute RIC, significantly lowered diastolic and mean arterial blood pressure (6). The studies included in this review were small and performed in a younger population, hence larger studies are needed to clarify the effect of RIC in the field of hypertension and, importantly, the elderly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants complete a 6-week intervention period during which the participants receive either RIPC or sham. There is then a 6-week washout period, after which participants complete the other intervention
| Arm | Type | Receives |
|---|---|---|
| Remote Ischaemic Preconditioning | Active comparator | Device: Remote Ischaemic PreconditioningRIPC is induced by 4 cycles of 5 minutes of healthy upper limb ischaemia followed by 5 minutes reperfusion. Ischaemia is induced by inflation of a blood pressure cuff to 20mmHg above systolic blood pressure. RIPC is conducted 3 times weekly for 6-weeks. |
| Sham remote ischaemic preconditioning | Sham comparator | Device: Sham Remote Ischaemic PreconditioningSham RIPC is induced by 4 cycles of 5 minutes of healthy upper limb ischaemia followed by 5 minutes reperfusion. Ischaemia is induced by inflation of a blood pressure cuff to 20mmHg. RIPC is conducted 3 times weekly for 6-weeks |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Participant is aged >65y and <85y.
- Participant is willing and able to give informed consent for participation in the study.
- Participant is physically able to perform RIPC.
Key exclusion criteria (5 listed)
- A BMI <18 or >35 kg/m2
- Active cardiovascular, cerebrovascular or respiratory disease: e.g. uncontrolled hypertension (BP > 160/100), active angina, heart failure (class III/IV), arrhythmia, right to left cardiac shunt, recent cardiac event, COPD, pulmonary hypertension or recent (6 mo) stroke.
- If history of hypertension, no recent alteration to antihypertensive medication (3 months).
- A history of, or current neurological or musculoskeletal conditions (e.g. epilepsy)
- Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance
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 Ischaemic PreconditioningRIPC is induced by 4 cycles of 5 minutes of healthy upper limb ischaemia followed by 5 minutes reperfusion. Ischaemia is induced by inflation of a blood pressure cuff to 20mmHg above systolic blood pressure. RIPC is conducted 3 times weekly for 6-weeks. Clinic blood pressure is measured at weeks 0, 3 and 6. 24-hour blood pressure is measured at weeks 0 and 6. | Device | Remote Ischaemic Preconditioning |
| Sham Remote Ischaemic PreconditioningSham RIPC is induced by 4 cycles of 5 minutes of healthy upper limb ischaemia followed by 5 minutes reperfusion. Ischaemia is induced by inflation of a blood pressure cuff to 20mmHg. RIPC is conducted 3 times weekly for 6-weeks. Clinic blood pressure is measured at weeks 0, 3 and 6. 24-hour blood pressure is measured at weeks 0 and 6. | Device | Sham remote ischaemic preconditioning |
Primary outcome
Clinic systolic blood pressure
Time frame: Measured at baseline, week 3 and week 6
Changes in blood pressure measured by automated sphygmomanometer over 6 weeks. Measured after participants have rested for 10 minutes in a temperature controlled room.
8 secondary outcomes
Clinic diastolic blood pressure
Time frame: Measured at baseline, week 3 and week 6
Clinic Mean arterial pressure
Time frame: Measured at baseline, week 3 and week 6
24-hour systolic blood pressure
Time frame: Measured at baseline and week 6
24-hour diastolic blood pressure
Time frame: Measured at baseline and week 6
24-hour mean arterial pressure
Time frame: Measured at baseline and week 6
Flow mediated dilatation (FMD)
Time frame: Measured at baseline, week 3 and week 6
Pulsewave velocity (PWV)
Time frame: Measured at baseline, week 3 and week 6
Serum biomarkers
Time frame: Measured at baseline and week 6.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Background: PubMed 33501848Virani SS, Alonso A, Aparicio HJ, Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Cheng S, Delling FN, Elkind MSV, Evenson KR, Ferguson JF, Gupta DK, Khan SS, Kissela BM, Knutson KL, Lee CD, Lewis TT, Liu J, Loop MS, Lutsey PL, Ma J, Mackey J, Martin SS, Matchar DB, Mussolino ME, Navaneethan SD, Perak AM, Roth GA, Samad Z, Satou GM, Schroeder EB, Shah SH, Shay CM, Stokes A, VanWagner LB, Wang NY, Tsao CW; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2021 Update: A Report From the American Heart Association. Circulation. 2021 Feb 23;143(8):e254-e743. doi: 10.1161/CIR.0000000000000950. Epub 2021 Jan 27.
- BackgroundHealth matters: combating high blood pressure: Public Health England; 2017
- Backgroundhttps://www.stroke.org.uk/what-is-stroke/stroke-statistics
- Background: PubMed 25889849Guthrie B, Makubate B, Hernandez-Santiago V, Dreischulte T. The rising tide of polypharmacy and drug-drug interactions: population database analysis 1995-2010. BMC Med. 2015 Apr 7;13:74. doi: 10.1186/s12916-015-0322-7.
- Background: PubMed 15231615Pirmohamed M, James S, Meakin S, Green C, Scott AK, Walley TJ, Farrar K, Park BK, Breckenridge AM. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. BMJ. 2004 Jul 3;329(7456):15-9. doi: 10.1136/bmj.329.7456.15.
- Background: PubMed 33748739Baffour-Awuah B, Dieberg G, Pearson MJ, Smart NA. The effect of remote ischaemic conditioning on blood pressure response: A systematic review and meta-analysis. Int J Cardiol Hypertens. 2021 Feb 23;8:100081. doi: 10.1016/j.ijchy.2021.100081. eCollection 2021 Mar.
- 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.
Timothy England, MB ChB PhD principal investigator
University of Nottingham
Bethan Phillips, PhD principal investigator
University of Nottingham
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 Ischaemic Preconditioning in people with Hypertension and Vascular Diseases, run by University of Nottingham at 1 site in United Kingdom.
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 5 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 4 Jun 2025. 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 United Kingdom. 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?
Clinic systolic blood pressure (time frame: Measured at baseline, week 3 and week 6). 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 NCT05971407, which also lists 6 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 4 Jun 2025.