NCT04952935

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 21, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 7, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

July 7, 2021

Status Verified

July 1, 2021

Enrollment Period

1.2 years

First QC Date

May 21, 2021

Last Update Submit

July 2, 2021

Conditions

Congestive Heart FailureHypotension

Keywords

acupuncturemidodrinefludrocortisonerandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Blood Pressure

    Change in mean arterial blood pressure, as measured by blood pressure cuff in sitting position

    9 weeks

Secondary Outcomes (7)

  • Blood Pressure adjusted for Medication

    9 weeks

  • Standing Blood Pressure adjusted for Medication

    9 weeks

  • Medication Dose Change

    9 weeks

  • Got off medications

    9 weeks

  • NYHA Class

    Start, 5 weeks, and 9 weeks

  • +2 more secondary outcomes

Study Arms (2)

True Acupuncture

EXPERIMENTAL
Procedure: True Acupuncture

Sham Acupuncture

SHAM COMPARATOR
Procedure: Sham Acupuncture

Interventions

True AcupuncturePROCEDURE

Delivery of four acupuncture seeds (no needles involved) to the head and neck area at true acupuncture points.

True Acupuncture
Sham AcupuncturePROCEDURE

Delivery of four acupuncture seeds (no needles involved) to the head and neck area at non-acupuncture points.

Sham Acupuncture

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Scripps La Jolla Medical Center

La Jolla, California, 92037, United States

RECRUITING

Scripps Shiley Integrative Center

La Jolla, California, 92037, United States

RECRUITING

MeSH Terms

Conditions

Heart FailureHypotension

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Christopher Suhar, MD

    Scripps Health

    PRINCIPAL INVESTIGATOR

  • Yu-Ming Ni, MD

    Scripps Health

    PRINCIPAL INVESTIGATOR

  • Rajeev Mohan, MD

    Scripps Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu-Ming Ni, MD

CONTACT

858-554-3360acupunctureHF@scrippshealth.org

Christopher Suhar, MD

CONTACT

858-554-3300

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized double-blinded sham-controlled clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiology Fellow

Study Record Dates

First Submitted

May 21, 2021

First Posted

July 7, 2021

Study Start

April 20, 2021

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

July 7, 2021

Record last verified: 2021-07

Locations

US(2)