Acupuncture for the Treatment of Medication-Dependent Hypotension in Heart Failure

Phase 1

• Conditions: Congestive Heart Failure; Hypotension
• Interventions: Procedure: True Acupuncture; Procedure: Sham Acupuncture

• Registration Number: NCT04952935
• Lead Sponsor: Scripps Health

Brief Summary

Acupuncture is believed to increase blood pressure in people who struggle with low blood pressure. This is a common problem facing people with heart failure, and sometimes these people need to take medications to artificially increase their blood pressure. This study is designed to determine if using acupuncture in people with heart failure can improve their blood pressure enough to not require medications to artificially increase blood pressure.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-20
• Study First Submitted: 2021-05-21
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-02
• Last Update Submitted: 2021-07-02
• Study First Posted: 2021-07-07
• Last Update Posted: 2021-07-07
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age greater than or equal to 18 years old
• Chronic congestive heart failure (systolic or diastolic)
• Medication list includes midodrine or fludrocortisone, either taking as scheduled or as needed

Exclusion Criteria

• History of acupuncture of any kind in the last 3 months
• Acute decompensated heart failure, as indicated by clinical picture at time of enrollment
• Currently on a mechanical device (LVAD, TAH, ECMO)
• History of hepatorenal syndrome, adrenal insufficiency, for which midodrine and fludrocortisone respectively is specifically being used to treat that condition
• Lack of suitable locations for which to place acupuncture seeds

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
True Acupuncture	True Acupuncture	-
Sham Acupuncture	Sham Acupuncture	-

Primary Outcome Measures

Name	Time	Method
Blood Pressure	9 weeks	Change in mean arterial blood pressure, as measured by blood pressure cuff in sitting position

Secondary Outcome Measures

Name	Time	Method
NYHA Class	Start, 5 weeks, and 9 weeks	Change in NYHA Class
Quality of Life Score	Start, 5 weeks, and 9 weeks	Change in Quality of Life scores by VAS
Medication Dose Change	9 weeks	Percentage change in median dose of midodrine or fludrocortisone (in mg per week)
Composite Safety Outcome	Throughout study, total time 9 weeks	Composite of skin injury, symptomatic hypotension, hospitalization for heart failure exacerbation or syncope or hypotension, implantation of LVAD/MCS device or heart transplantation, or all-cause death
Standing Blood Pressure adjusted for Medication	9 weeks	Change in mean arterial blood pressure, as measured by blood pressure cuff in standing position, adjusted for midodrine/fludrocortisone dose as covariate
Got off medications	9 weeks	Number of patients who came off of midodrine or fludrocortisone by end of study
Blood Pressure adjusted for Medication	9 weeks	Change in mean arterial blood pressure, as measured by blood pressure cuff in sitting position, adjusted for midodrine/fludrocortisone dose as covariate

Trial Locations

Locations (2)

Scripps La Jolla Medical Center; 🇺🇸 La Jolla, California, United States

Scripps Shiley Integrative Center; 🇺🇸 La Jolla, California, United States