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Long-term of Remote Ischemic Preconditioning and Mindfulness in Patients With Mild Hypertension

ConditionHypertension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHenan Institute of Cardiovascular Epidemiology

About this trial

According to the latest survey data of China hypertension annual meeting, there are about 300 million patients with hypertension in China, with 10 million new cases of hypertension each year, and there is an obvious trend of younger people. In particular, young and middle-aged people are in a state of mild hypertension for a long time, which causes great pressure on health and medical treatment. At present, the main clinical measures for mild hypertension are to change their eating habits, quit smoking and alcohol, exercise and other lifestyle changes, as well as drug control. For most patients with mild hypertension, drug control is not the best choice. It has been reported that remote ischemic preconditioning (RIPC) may play an effective role in reducing blood pressure .The purpose of this study was to investigate the extent of long-term application of RIPC to reduce blood pressure in patients with mild hypertension.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed patients with mild hypertension (SBP: 140~159mmHg; DBP: 90~99mmHg)

Disqualifiers

Cannot tolerate RIPC

Non-essential hypertension

patients who have uncontrolled severe arrhythmia, diabetes, electrolyte disturbance

patients who have severe organic diseases such acute myocardial infarction, cardiac insufficiency, abnormal renal function, etc.

Trial design

Design model

Factorial

Treatments tested in this trial

  • CRIC

    Device

    Remote Ischemic Conditioning (CRIC): Twice daily for 12 weeks using an automated cuff device. Each 30-minute session consisted of 3 cycles of 6 min inflation (pressure individualized: resting SBP-based increments of +40/+30/+20 mmHg depending on baseline SBP level) followed by 4 min deflation (0 mmHg).

  • MFT

    Behavioral

    Sham CRIC: Identical schedule and device; each cycle used fixed 5 min inflation at 60 mmHg (non-ischemic) followed by 5 min deflation.

  • sham CRIC

    Other intervention

    Sham CRIC: Identical schedule and device; each cycle used fixed 5 min inflation at 60 mmHg (non-ischemic) followed by 5 min deflation.

  • sham MFT

    Other intervention

    Sham MFT: Twice daily equivalent-duration audio of looped neutral nature sounds (ocean waves, flowing water, birdsong) without mindfulness instructions.

Treatment groups

400 Participants
are divided into 4 treatment groups
Group A: CRIC+MFTExperimental treatment 2 interventions
Group B: sham CRIC+MFTExperimental treatment 2 interventions
Group C: CRIC+sham MFTExperimental treatment 2 interventions
Group D: Sham CRIC+Sham MFTPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Mean systolic blood pressure

24-hour Mean systolic blood pressure measured by Ambulatory blood pressure monitoring

Time frame
3 months
2

Mean diastolic blood pressure

24-hour Mean diastolic blood pressure measured by Ambulatory blood pressure monitoring

Time frame
3 months

Secondary outcomes

1

Concentration of Renalase

blood renalase concentration

Time frame
3 months
2

Concentration of catecholamine

Blood catecholamine concentration

Time frame
3 months
3

Concentration of adenosine

blood adenosine concentration

Time frame
3 months
4

Concentration of bradykinin

blood bradykinin concentration

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Henan Institute of Cardiovascular Epidemiology

Lead sponsor

Source ClinicalTrials.gov
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