Clinical trial NCT05971407: The Effect of Chronic Remote Ischaemic Preconditioning on Blood Pressure in Older Adults
Official title: The Effect of Chronic Remote Ischaemic Preconditioning on Blood Pressure in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Vascular Diseases
Keywords: Remote Ischaemic Preconditioning
Non-pharmacological
Remote Ischaemic Conditioning
Randomised Controlled Trial
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Clinic systolic blood pressure
timeFrame: Measured at baseline, week 3 and week 6
Secondary outcomes:
measure: Clinic diastolic blood pressure
timeFrame: Measured at baseline, week 3 and week 6
measure: Clinic Mean arterial pressure
timeFrame: Measured at baseline, week 3 and week 6
measure: 24-hour systolic blood pressure
timeFrame: Measured at baseline and week 6
measure: 24-hour diastolic blood pressure
timeFrame: Measured at baseline and week 6
measure: 24-hour mean arterial pressure
timeFrame: Measured at baseline and week 6
measure: Flow mediated dilatation (FMD)
timeFrame: Measured at baseline, week 3 and week 6
measure: Pulsewave velocity (PWV)
timeFrame: Measured at baseline, week 3 and week 6
measure: Serum biomarkers
timeFrame: Measured at baseline and week 6.
Other outcomes:
Locations:
city: Derby
country: United Kingdom
facility: School of Medicine, Royal Derby Hospital Site, University of Nottingham
state: Derbyshire
Study officials:
affiliation: University of Nottingham
name: Timothy England, MB ChB PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Nottingham
name: Bethan Phillips, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Health matters: combating high blood pressure: Public Health England; 2017
citation: https://www.stroke.org.uk/what-is-stroke/stroke-statistics
citation: 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.
citation: Pirmohamed 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.
citation: Baffour-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.