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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| True Acupuncture | Experimental |
| |
| Sham Acupuncture | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| True Acupuncture | Procedure | Delivery of four acupuncture seeds (no needles involved) to the head and neck area at true acupuncture points. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure | Change in mean arterial blood pressure, as measured by blood pressure cuff in sitting position | 9 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu-Ming Ni, MD | Contact | 858-554-3360 | acupunctureHF@scrippshealth.org | |
| Christopher Suhar, MD | Contact | 858-554-3300 |
| Name | Affiliation | Role |
|---|---|---|
| Christopher Suhar, MD | Scripps Health | Principal Investigator |
| Yu-Ming Ni, MD | Scripps Health | Principal Investigator |
| Rajeev Mohan, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps La Jolla Medical Center | Recruiting | La Jolla | California | 92037 | United States |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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Randomized double-blinded sham-controlled clinical trial
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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.
| Sham Acupuncture | Procedure | Delivery of four acupuncture seeds (no needles involved) to the head and neck area at non-acupuncture points. |
|
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 |
| Scripps Health |
| Principal Investigator |
| Scripps Shiley Integrative Center | Recruiting | La Jolla | California | 92037 | United States |
|