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

Congestive Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04952935
• Other study ID #: IRB-20-7569
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: April 20, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: July 2021
• Source: Scripps Health
• Contact: Yu-Ming Ni, MD
• Phone: 858-554-3360
• Email: acupunctureHF[@]scrippshealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure
• Hypotension

Intervention

Procedure:
• True Acupuncture
Delivery of four acupuncture seeds (no needles involved) to the head and neck area at true acupuncture points.
• Sham Acupuncture
Delivery of four acupuncture seeds (no needles involved) to the head and neck area at non-acupuncture points.

Locations

Country	Name	City	State
United States	Scripps La Jolla Medical Center	La Jolla	California
United States	Scripps Shiley Integrative Center	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
Scripps Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure	Change in mean arterial blood pressure, as measured by blood pressure cuff in sitting position	9 weeks
Secondary	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
Secondary	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
Secondary	Medication Dose Change	Percentage change in median dose of midodrine or fludrocortisone (in mg per week)	9 weeks
Secondary	Got off medications	Number of patients who came off of midodrine or fludrocortisone by end of study	9 weeks
Secondary	NYHA Class	Change in NYHA Class	Start, 5 weeks, and 9 weeks
Secondary	Quality of Life Score	Change in Quality of Life scores by VAS	Start, 5 weeks, and 9 weeks
Secondary	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