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Clinical Trials/NCT05971407
NCT05971407
Completed
Not Applicable

The Effect of Chronic Remote Ischaemic Preconditioning on Blood Pressure in Older Adults

University of Nottingham1 site in 1 country60 target enrollmentSeptember 25, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension
Sponsor
University of Nottingham
Enrollment
60
Locations
1
Primary Endpoint
Clinic systolic blood pressure
Status
Completed
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 25, 2022
End Date
December 31, 2024
Last Updated
11 months ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Bethan Phillips

Professor

University of Nottingham

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Clinic Mean arterial pressure(Measured at baseline, week 3 and week 6)
  • 24-hour diastolic blood pressure(Measured at baseline and week 6)
  • Clinic diastolic blood pressure(Measured at baseline, week 3 and week 6)
  • 24-hour systolic blood pressure(Measured at baseline and week 6)
  • 24-hour mean arterial pressure(Measured at baseline and week 6)
  • Flow mediated dilatation (FMD)(Measured at baseline, week 3 and week 6)
  • Pulsewave velocity (PWV)(Measured at baseline, week 3 and week 6)
  • Serum biomarkers(Measured at baseline and week 6.)

Study Sites (1)

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