Remote Ischemic Conditioning for the Treatment of Resistant Hypertension

Resistant Hypertension Clinical Trial

Official title:

Efficacy and Safety of Remote Ischemic Conditioning for the Treatment of Resistant Hypertension: a Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05426707
• Other study ID #: RIC-Resistant HTN
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: March 30, 2023

Study information

• Verified date: September 2022
• Source: Capital Medical University
• Contact: Xunming Ji, MD, PhD
• Phone: 83199430
• Email: jixm[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Resistant hypertension is defined as a blood pressure of 140/90 mmHg or higher despite adherence to at least three antihypertensive drugs (including one diuretic), accounting for 20% to 30% of patients with hypertension. Compared with patients with well-controlled blood pressure, the cardiovascular risk of resistant hypertension is increased by about 50%. Limb remote ischemic conditioning (LRIC) triggers endogenous protective effects through transient and repeated ischemia in the limb to protect remote tissues and organs. The mechanisms of LRIC involve the regulation of the autonomic nervous system, the release of humoral factors, improvement of vascular endothelial function, and modulation of immune/inflammatory responses, which can antagonize the pathogenesis of hypertension through multiple pathways to lead to a drop in BP theoretically. This theory has been preliminarily confirmed by several small sample-size studies in non-resistant hypertension. This study aims to explore the efficacy and safety of remote ischemia adaptation for the treatment of resistant hypertension.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 30, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Hypertension
• Resistant Hypertension

Intervention

Device:
• RIC
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.
• Sham-RIC
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ji Xunming,MD,PhD

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes of 24 h average diasolic blood pressure	Changes of 24 h average diasolic blood pressure from baseline to 8 weeks	from baseline to 8 weeks
Secondary	Changes of daytime average systolic blood pressure	Changes of daytime average systolic blood pressure from baseline to 8 weeks	from baseline to 8 weeks
Secondary	Changes of daytime average diastolic blood pressure	Changes of daytime average diastolic blood pressure from baseline to 8 weeks	from baseline to 8 weeks
Secondary	Changes of nighttime average systolic blood pressure	Changes of nighttime average systolic blood pressure from baseline to 8 weeks	from baseline to 8 weeks
Secondary	Changes of nighttime average diastolic blood pressure	Changes of nighttime average diastolic blood pressure from baseline to 8 weeks	from baseline to 8 weeks
Secondary	Changes of 24 h average heart rate	Changes of 24 h average heart rate from baseline to 8 weeks	from baseline to 8 weeks
Secondary	Changes of office systolic blood pressure	Changes of office systolic blood pressure from baseline to 8 weeks	from baseline to 8 weeks
Secondary	Changes of office diastolic blood pressure	Changes of office diastolic blood pressure from baseline to 8 weeks	from baseline to 8 weeks
Secondary	Changes of home systolic blood pressure	Changes of home systolic blood pressure from baseline to 8 weeks	from baseline to 8 weeks
Secondary	Changes of home diastolic blood pressure	Changes of home diastolic blood pressure from baseline to 8 weeks	from baseline to 8 weeks