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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypotension; Congestive Heart Failure
• Intervention / Treatment: Procedure: True Acupuncture; Procedure: Sham Acupuncture

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Yu-Ming Ni, MD; Phone Number: 858-554-3360; Email: acupunctureHF@scrippshealth.org
• Study Contact Backup: Name: Christopher Suhar, MD; Phone Number: 858-554-3300

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Recruiting
      • Scripps La Jolla Medical Center
      • Contact: Yu-Ming Ni, MD; Phone Number: 858-554-3360; Email: acupunctureHF@scrippshealth.org
      • Contact: Christopher Suhar, MD; Phone Number: 858-554-3300
      • Sub-Investigator: Yu-Ming Ni, MD
    • La Jolla, California, United States, 92037
      • Recruiting
      • Scripps Shiley Integrative Center
      • Contact: Yu-Ming Ni, MD; Phone Number: 858-554-3360; Email: acupunctureHF@scrippshealth.org
      • Contact: Christopher Suhar, MD; Phone Number: 858-554-3300
      • Sub-Investigator: Yu-Ming Ni, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: True Acupuncture	Procedure: True Acupuncture; Delivery of four acupuncture seeds (no needles involved) to the head and neck area at true acupuncture points.
SHAM_COMPARATOR: Sham Acupuncture	Procedure: Sham Acupuncture; Delivery of four acupuncture seeds (no needles involved) to the head and neck area at non-acupuncture points.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure	Change in mean arterial blood pressure, as measured by blood pressure cuff in sitting position	9 weeks

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Scripps Health
• Investigators: Principal Investigator: Christopher Suhar, MD, Scripps Health; Principal Investigator: Yu-Ming Ni, MD, Scripps Health; Principal Investigator: Rajeev Mohan, MD, Scripps Health

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 20, 2021
• Primary Completion (ANTICIPATED): July 1, 2022
• Study Completion (ANTICIPATED): July 1, 2022

Study Registration Dates

• First Submitted: May 21, 2021
• First Submitted That Met QC Criteria: July 2, 2021
• First Posted (ACTUAL): July 7, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 7, 2021
• Last Update Submitted That Met QC Criteria: July 2, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: randomized controlled trial; acupuncture; midodrine; fludrocortisone
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Heart Failure; Hypotension
• Other Study ID Numbers: IRB-20-7569

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No