NCT04753840

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
56mo left

Started Jul 2021

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Jul 2021Dec 2030

First Submitted

Initial submission to the registry

February 10, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 15, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

July 3, 2021

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Expected
Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

4.4 years

First QC Date

February 10, 2021

Last Update Submit

September 12, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Mean systolic blood pressure

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

    3 months

  • Mean diastolic blood pressure

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

    3 months

Secondary Outcomes (5)

  • Concentration of Renalase

    3 months

  • Concentration of catecholamine

    3 months

  • Concentration of adenosine

    3 months

  • Concentration of bradykinin

    3 months

  • Concentration of renin

    3 months

Study Arms (3)

Experimental A: Drug group+lifestyle intervention

EXPERIMENTAL

Experimental group A used only one antihypertensive drug (ACEI / ARB, beta blocker, calcium channel blocker, diuretic, etc.) plus lifestyle intervention to control blood pressure.

Other: Antihypertensive drugsBehavioral: lifestyle intervention

Experimental B: RIPC group+lifestyle intervention

EXPERIMENTAL

The experimental group B received ripc treatment of upper limbs every day plus lifestyle intervention until the end of the follow-up. The treatment time was 40 minutes per day, 10 minutes as a cycle (cuff inflated to 200 mmHg and maintained for 5 minutes, then deflated for 5 minutes to start the next cycle), a total of 4 cycles.

Other: remote ischemic preconditioning(RIPC)Behavioral: lifestyle intervention

Experimental c: lifestyle intervention

OTHER

The control group take lifestyle intervention to control blood pressure, such as changing dietary habits, smoking cessation and alcohol restriction, exercise and so on.

Behavioral: lifestyle intervention

Interventions

One of ACEI / ARB, beta blocker, calcium channel blocker, diuretic

Experimental A: Drug group+lifestyle intervention

40 minutes per day, 10 minutes as a cycle (cuff inflated to 200 mmHg and maintained for 5 minutes, then deflated for 5 minutes to start the next cycle), a total of 4 cycles.

Experimental B: RIPC group+lifestyle intervention

Such as changing dietary habits, smoking cessation and alcohol restriction, exercise and so on.

Experimental A: Drug group+lifestyle interventionExperimental B: RIPC group+lifestyle interventionExperimental c: lifestyle intervention

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai central China Cardiovascular hospital

Zhengzhou, Henan, 450008, China

RECRUITING

Related Publications (2)

  • Jones H, Hopkins N, Bailey TG, Green DJ, Cable NT, Thijssen DH. Seven-day remote ischemic preconditioning improves local and systemic endothelial function and microcirculation in healthy humans. Am J Hypertens. 2014 Jul;27(7):918-25. doi: 10.1093/ajh/hpu004. Epub 2014 Mar 13.

    PMID: 24627443BACKGROUND
  • Moro L, Pedone C, Mondi A, Nunziata E, Antonelli Incalzi R. Effect of local and remote ischemic preconditioning on endothelial function in young people and healthy or hypertensive elderly people. Atherosclerosis. 2011 Dec;219(2):750-2. doi: 10.1016/j.atherosclerosis.2011.08.046. Epub 2011 Sep 7.

    PMID: 21945497BACKGROUND

MeSH Terms

Conditions

Hypertension

Interventions

Antihypertensive Agents

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Muwei Li, MD

    Chinese Academy of Medical Sciences, Fuwai Hospital

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2021

First Posted

February 15, 2021

Study Start

July 3, 2021

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2030

Last Updated

September 15, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

IPD can be obtained from the researcher upon reasonable request

Locations