Recruiting
Phase 1
Phase 2

Acupuncture

Sponsor:

Scripps Health

Code:

NCT04952935

Conditions

Congestive Heart Failure

Hypotension

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

True Acupuncture

Sham Acupuncture

Study Details

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.

Conditions

Congestive Heart Failure

Hypotension

Study ID

NCT04952935

Start date

Apr 20, 2021

Status verified date

Jul, 2021

Completion date

Jul 1, 2022

Anticipated

Primary completion date

Jul 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: True Acupuncture

sham comparator: Sham Acupuncture

Interventions

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.

Primary outcome measure

  • Blood Pressure [ Time Frame: 9 weeks ]

Central Contacts and Locations

Central contacts

Yu-Ming Ni, MD

858-554-3360acupunctureHF@scrippshealth.org

Christopher Suhar, MD

858-554-3300

Locations

Scripps La Jolla Medical Center

Recruiting

La Jolla, California, United States, 92037

Contacts

Yu-Ming Ni, MD

858-554-3360acupunctureHF@scrippshealth.org

Christopher Suhar, MD

858-554-3300

Principal Investigator:

Christopher Suhar, MD

Scripps Shiley Integrative Center

Recruiting

La Jolla, California, United States, 92037

Contacts

Yu-Ming Ni, MD

858-554-3360acupunctureHF@scrippshealth.org

Christopher Suhar, MD

858-554-3300

Principal Investigator:

Christopher Suhar, MD

More Information

Sponsor

Scripps Health

Last update posted

Jul 7, 2021

Last verified

Jul, 2021

Keywords

  • acupuncture
  • midodrine
  • fludrocortisone
  • randomized controlled trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Scripps Health on 2021-07-07.