Hypertension Clinical Trial
— RIPCoOfficial title:
The Effect of Chronic Remote Ischaemic Preconditioning on Blood Pressure in Older Adults
The purpose of this study is to assess whether remote ischaemic conditioning, applied chronically, improves vascular health in older adults
Status | Recruiting |
Enrollment | 60 |
Est. completion date | October 31, 2024 |
Est. primary completion date | October 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years to 85 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | School of Medicine, Royal Derby Hospital Site, University of Nottingham | Derby | Derbyshire |
Lead Sponsor | Collaborator |
---|---|
University of Nottingham |
United Kingdom,
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. — View 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. — View Citation
Health matters: combating high blood pressure: Public Health England; 2017
https://www.stroke.org.uk/what-is-stroke/stroke-statistics
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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 at baseline, week 3 and week 6 | |
Secondary | 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 at baseline, week 3 and week 6 | |
Secondary | 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 at baseline, week 3 and week 6 | |
Secondary | 24-hour systolic blood pressure | Changes in blood pressure measured by 24-hour blood pressure monitor. | Measured at baseline and week 6 | |
Secondary | 24-hour diastolic blood pressure | Changes in blood pressure measured by 24-hour blood pressure monitor. | Measured at baseline and week 6 | |
Secondary | 24-hour mean arterial pressure | Changes in blood pressure measured by 24-hour blood pressure monitor. | Measured at baseline and week 6 | |
Secondary | 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 at baseline, week 3 and week 6 | |
Secondary | 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 at baseline, week 3 and week 6 | |
Secondary | Serum biomarkers | Biomarkers of RIC mechanism will be quantified by ELISA from plasma samples collected before and after intervention. | Measured at baseline and week 6. |
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