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

Study Overview
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Brief Summary
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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.

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

Conditions
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Congestive Heart Failure, Hypotension

Intervention / Treatment
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* Procedure: True Acupuncture
* Procedure: Sham Acupuncture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized double-blinded sham-controlled clinical trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: True Acupuncture<br> | Procedure: True Acupuncture<br>* Delivery of four acupuncture seeds (no needles involved) to the head and neck area at true acupuncture points.<br>|
| Sham Comparator: Sham Acupuncture<br> | Procedure: Sham Acupuncture<br>* Delivery of four acupuncture seeds (no needles involved) to the head and neck area at non-acupuncture points.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure | Change in mean arterial blood pressure, as measured by blood pressure cuff in sitting position | 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure adjusted for Medication | Change in mean arterial blood pressure, as measured by blood pressure cuff in sitting position, adjusted for midodrine/fludrocortisone dose as covariate | 9 weeks | 
| Standing Blood Pressure adjusted for Medication | Change in mean arterial blood pressure, as measured by blood pressure cuff in standing position, adjusted for midodrine/fludrocortisone dose as covariate | 9 weeks | 
| Medication Dose Change | Percentage change in median dose of midodrine or fludrocortisone (in mg per week) | 9 weeks | 
| Got off medications | Number of patients who came off of midodrine or fludrocortisone by end of study | 9 weeks | 
| NYHA Class | Change in NYHA Class | Start, 5 weeks, and 9 weeks | 
| Quality of Life Score | Change in Quality of Life scores by VAS | Start, 5 weeks, and 9 weeks | 
| Composite Safety Outcome | 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 | Throughout study, total time 9 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acupuncture, midodrine, fludrocortisone, randomized controlled trial