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

Scripps Health

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Hypotension; Congestive Heart Failure

Treatments: Procedure: True Acupuncture; Procedure: Sham Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT04952935

IRB-20-7569

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

True Acupuncture

Experimental group

Treatment:

Procedure: True Acupuncture

Sham Acupuncture

Sham Comparator group

Treatment:

Procedure: Sham Acupuncture