NCT07562477

Brief Summary

This study is a multicenter, prospective, randomized, open-label, parallel-controlled clinical trial. The study participants are adult patients with hypertension who have been long-term residents (for \>6 months) in high-altitude regions (≥2500 m). They are randomly assigned to one of two groups: a conventional medication group and a remote ischemic conditioning (RIC) intervention group. The study aims to evaluate the effectiveness of a standardized 30-day RIC intervention, as an add-on to conventional antihypertensive medication, for reducing blood pressure in hypertensive immigrants living at high altitude.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
184

participants targeted

Target at P25-P50 for phase_3 hypertension

Timeline
26mo left

Started May 2026

Typical duration for phase_3 hypertension

Status
not yet 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

First Submitted

Initial submission to the registry

April 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 1, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

May 10, 2026

Expected
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2028

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

1.7 years

First QC Date

April 25, 2026

Last Update Submit

April 25, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percentage change in 24-hour mean systolic blood pressure from baseline.

    30 days

Study Arms (2)

RIC group

EXPERIMENTAL
Device: RIC

Control group

NO INTERVENTION

Interventions

RICDEVICE

Participants will undergo a 7-day remote ischemic conditioning (RIC) intervention prior to ascending to high altitude. On the day following the completion of the RIC intervention, they will ascend to a high-altitude region (\>2500 m). Standardized RIC treatment will be administered using a dedicated RIC device. Each intervention session consists of 5 cycles. Every cycle includes 5 minutes of bilateral upper limb ischemia followed by 5 minutes of reperfusion. The cuff pressure for inducing ischemia is set at 200 mmHg. The intervention is administered twice daily for 30 consecutive days.

RIC group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-60 years, of either sex; Continuous residence in a high-altitude region (\>2500 m) for more than 6 months, with no plan for long-term departure from the plateau during the study period; Meeting the diagnostic criteria for essential hypertension; Willing to provide written informed consent.

You may not qualify if:

  • Evidence of secondary hypertension; Severe dysfunction of vital organs (e.g., heart, liver, kidney, lungs); Active malignancy, uncontrolled hyperthyroidism, active autoimmune disease, or poorly controlled diabetes mellitus; Office blood pressure ≥180/110 mmHg, or 24-hour average blood pressure ≥170/100 mmHg; Hospitalization for hypertensive crisis or emergency at least once within the past 3 months; History of cardiovascular or cerebrovascular event within the past 3 months; Pregnancy, planned pregnancy, or lactation for female participants; Contraindications to RIC (e.g., severe peripheral arterial disease, venous thrombosis, or soft tissue injury in the upper limbs); Any other condition deemed by the investigator to be unsuitable for participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

April 25, 2026

First Posted

May 1, 2026

Study Start (Estimated)

May 10, 2026

Primary Completion (Estimated)

January 30, 2028

Study Completion (Estimated)

June 30, 2028

Last Updated

May 1, 2026

Record last verified: 2026-04