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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-20

Study Completion Date

2022-07-01

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.

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Detailed Description

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Conditions

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Congestive Heart Failure Hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized double-blinded sham-controlled clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Patient receives true or sham acupuncture, and patient is unaware of treatment assignment. Acupuncturist is aware of treatment assignment, as is the statistician who is aware of randomization assignment but not involved otherwise in the execution of clinical trial. Investigators, medical assistants, and patients' physicians are unaware of treatment assignment.

Study Groups

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True Acupuncture

Group Type EXPERIMENTAL

True Acupuncture

Intervention Type PROCEDURE

Delivery of four acupuncture seeds (no needles involved) to the head and neck area at true acupuncture points.

Sham Acupuncture

Group Type SHAM_COMPARATOR

Sham Acupuncture

Intervention Type PROCEDURE

Delivery of four acupuncture seeds (no needles involved) to the head and neck area at non-acupuncture points.

Interventions

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True Acupuncture

Delivery of four acupuncture seeds (no needles involved) to the head and neck area at true acupuncture points.

Intervention Type PROCEDURE

Sham Acupuncture

Delivery of four acupuncture seeds (no needles involved) to the head and neck area at non-acupuncture points.

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No