Back to resultsAcupuncture for the Treatment of Medication-Dependent Hypotension in Heart Failure
Primary Purpose
Congestive Heart Failure, Hypotension
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
True Acupuncture
Sham Acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Congestive Heart Failure focused on measuring acupuncture, midodrine, fludrocortisone, randomized controlled trial
Eligibility Criteria
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
Sites / Locations
- Scripps La Jolla Medical CenterRecruiting
- Scripps Shiley Integrative CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
True Acupuncture
Sham Acupuncture
Arm Description
Outcomes
Primary Outcome Measures
Blood Pressure
Change in mean arterial blood pressure, as measured by blood pressure cuff in sitting position
Secondary Outcome Measures
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
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
Medication Dose Change
Percentage change in median dose of midodrine or fludrocortisone (in mg per week)
Got off medications
Number of patients who came off of midodrine or fludrocortisone by end of study
NYHA Class
Change in NYHA Class
Quality of Life Score
Change in Quality of Life scores by VAS
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04952935
Brief Title
Acupuncture for the Treatment of Medication-Dependent Hypotension in Heart Failure
Official Title
Acupuncture for the Treatment of Medication-Dependent Hypotension in Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 20, 2021 (Actual)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Scripps Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure, Hypotension
Keywords
acupuncture, midodrine, fludrocortisone, randomized controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized double-blinded sham-controlled clinical trial
Masking
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
True Acupuncture
Arm Type
Experimental
Arm Title
Sham Acupuncture
Arm Type
Sham Comparator
Intervention Type
Procedure
Intervention Name(s)
True Acupuncture
Intervention Description
Delivery of four acupuncture seeds (no needles involved) to the head and neck area at true acupuncture points.
Intervention Type
Procedure
Intervention Name(s)
Sham Acupuncture
Intervention Description
Delivery of four acupuncture seeds (no needles involved) to the head and neck area at non-acupuncture points.
Primary Outcome Measure Information:
Title
Blood Pressure
Description
Change in mean arterial blood pressure, as measured by blood pressure cuff in sitting position
Time Frame
9 weeks
Secondary Outcome Measure Information:
Title
Blood Pressure adjusted for Medication
Description
Change in mean arterial blood pressure, as measured by blood pressure cuff in sitting position, adjusted for midodrine/fludrocortisone dose as covariate
Time Frame
9 weeks
Title
Standing Blood Pressure adjusted for Medication
Description
Change in mean arterial blood pressure, as measured by blood pressure cuff in standing position, adjusted for midodrine/fludrocortisone dose as covariate
Time Frame
9 weeks
Title
Medication Dose Change
Description
Percentage change in median dose of midodrine or fludrocortisone (in mg per week)
Time Frame
9 weeks
Title
Got off medications
Description
Number of patients who came off of midodrine or fludrocortisone by end of study
Time Frame
9 weeks
Title
NYHA Class
Description
Change in NYHA Class
Time Frame
Start, 5 weeks, and 9 weeks
Title
Quality of Life Score
Description
Change in Quality of Life scores by VAS
Time Frame
Start, 5 weeks, and 9 weeks
Title
Composite Safety Outcome
Description
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
Time Frame
Throughout study, total time 9 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu-Ming Ni, MD
Phone
858-554-3360
Email
acupunctureHF@scrippshealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher Suhar, MD
Phone
858-554-3300
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Suhar, MD
Organizational Affiliation
Scripps Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yu-Ming Ni, MD
Organizational Affiliation
Scripps Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rajeev Mohan, MD
Organizational Affiliation
Scripps Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scripps La Jolla Medical Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu-Ming Ni, MD
Phone
858-554-3360
Email
acupunctureHF@scrippshealth.org
First Name & Middle Initial & Last Name & Degree
Christopher Suhar, MD
Phone
858-554-3300
First Name & Middle Initial & Last Name & Degree
Yu-Ming Ni, MD
First Name & Middle Initial & Last Name & Degree
Christopher Suhar, MD
First Name & Middle Initial & Last Name & Degree
Rajeev Mohan, MD
Facility Name
Scripps Shiley Integrative Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu-Ming Ni, MD
Phone
858-554-3360
Email
acupunctureHF@scrippshealth.org
First Name & Middle Initial & Last Name & Degree
Christopher Suhar, MD
Phone
858-554-3300
First Name & Middle Initial & Last Name & Degree
Yu-Ming Ni, MD
First Name & Middle Initial & Last Name & Degree
Christopher Suhar, MD
First Name & Middle Initial & Last Name & Degree
Rajeev Mohan, MD
12. IPD Sharing Statement
Learn more about this trial
Acupuncture for the Treatment of Medication-Dependent Hypotension in Heart Failure
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