Remote Ischemic Conditioning for the Treatment of Resistant Hypertension

NCT05426707 | Unknown DMC

• 1 other identifier: RIC-Resistant HTN
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to explore the efficacy and safety of remote ischemia adaptation for the treatment of resistant hypertension.

Conditions

Resistant Hypertension

Keywords

Resistant Hypertension; Remote ischemic conditioning

Outcome Measures

Primary Outcomes (1)

• Changes of 24 h average systolic blood pressure

  Changes of 24 h average systolic blood pressure from baseline to 8 weeks

  from baseline to 8 weeks

Secondary Outcomes (10)

• Changes of 24 h average diasolic blood pressure

  from baseline to 8 weeks

• Changes of daytime average systolic blood pressure

  from baseline to 8 weeks

• Changes of daytime average diastolic blood pressure

  from baseline to 8 weeks

• Changes of nighttime average systolic blood pressure

  from baseline to 8 weeks

• Changes of nighttime average diastolic blood pressure

  from baseline to 8 weeks

Study Arms (2)

RIC group

EXPERIMENTAL

RIC is a non-invasive therapy that is performed by automated pneumatic cuffs placed on bilateral arms. The RIC protocol includes five cycles of 5-min inflation to 200mmHg and 5-min deflation.

Device: RIC

Sham RIC group

SHAM COMPARATOR

The Sham-RIC protocol include five cycles of 5-min inflation to 60 mmHg and 5-min deflation by placing automated pneumatic cuffs on bilateral arms.

Device: Sham-RIC

Interventions

RIC DEVICE

RIC is a non-invasive therapy that is performed by automated pneumatic cuffs placed on bilateral arms. The RIC protocol includes five cycles of 5-min inflation to 200mmHg and 5-min deflation.

RIC group

Sham-RIC DEVICE

The Sham-RIC protocol include five cycles of 5-min inflation to 60 mmHg and 5-min deflation by placing automated pneumatic cuffs on bilateral arms.

Sham RIC group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 30\~80 years old;
• Taking ≥ 3 antihypertensive drugs (including one diuretic) for more than 4 weeks regularly;
• Office blood pressure ≥ 140/90mmhg, and 24 h average blood pressure ≥ 130/80 mmHg;
• Willing to participate in the study, follow the study protocol, and provide informed consent.

You may not qualify if:

• Secondary hypertension;
• eGFR\<45ml/min/1.73m2；
• Office blood pressure ≥180/110 mmHg, and 24 h average blood pressure ≥ 170/100 mmHg；
• Hypertensive crisis occurred within 3 months;
• Type 1 diabetes;
• Cardiovascular events occurred within 3 months;
• Atrial fibrillation;
• Presence of any severe disease that adversely affects the subject or study;
• Patients with contraindication for remote ischemic conditioning, such as vascular injury, soft tissue injury, orthopedic injury, or arm infection;
• Pregnancy, lactation, or planned pregnancy;
• Patients not suitable for this trial considered by researchers for other reasons；
• Participation in another device or drug trial simultaneously.

Sponsors & Collaborators

• Ji Xunming,MD,PhD: lead

Study Officials

• Xunming Ji, MD, PhD

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xunming Ji, MD, PhD

CONTACT

83199430; jixm@ccmu.edu.cn

Wenting Guo

CONTACT

18368910464; 18368910464@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: June 22, 2022
• Study Start: October 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: March 30, 2023
• Last Updated: September 8, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share