Congestive Heart Failure, Hypotension
Conditions
Keywords
acupuncture, midodrine, fludrocortisone, randomized controlled trial
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.
Interventions
PROCEDURETrue Acupuncture
Delivery of four acupuncture seeds (no needles involved) to the head and neck area at true acupuncture points.
PROCEDURESham Acupuncture
Delivery of four acupuncture seeds (no needles involved) to the head and neck area at non-acupuncture points.
Sponsors
Scripps Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
Randomized double-blinded sham-controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | 9 weeks | Change in mean arterial blood pressure, as measured by blood pressure cuff in sitting position |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Medication Dose Change | 9 weeks | Percentage change in median dose of midodrine or fludrocortisone (in mg per week) |
| 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 |
| Quality of Life Score | Start, 5 weeks, and 9 weeks | Change in Quality of Life scores by VAS |
| 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 |
| NYHA Class | Start, 5 weeks, and 9 weeks | Change in NYHA Class |
Countries
United States
Contacts
Primary ContactYu-Ming Ni, MD
Backup ContactChristopher Suhar, MD
Outcome results
None listed