Congestive Heart FailurePhase 1/2NCT04952935
Acupuncture for the Treatment of Medication-Dependent Hypotension in Heart Failure
A Phase 1/2 study testing True Acupuncture in people with Congestive Heart Failure and Hypotension, run by Scripps Health at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure, Hypotension
- What is being tested?
- True Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Apr 2021to 1 Jul 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Christopher Suhar, MD contact
United States2 sites, 2 recruiting
- Recruiting
Scripps La Jolla Medical Center
La Jolla, California, 92037
Yu-Ming Ni, MD, 858-554-3360, acupunctureHF@scrippshealth.org
Christopher Suhar, MD, 858-554-3300
- Recruiting
Scripps Shiley Integrative Center
La Jolla, California, 92037
Yu-Ming Ni, MD, 858-554-3360, acupunctureHF@scrippshealth.org
Christopher Suhar, MD, 858-554-3300
About this study
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
- Being tested
- True Acupuncture, Sham Acupuncture
- Keywords
- acupuncture, midodrine, fludrocortisone, randomized controlled trial
- Medical subject headings
- Heart Failure, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
True AcupunctureProcedure or surgery
Delivery of four acupuncture seeds (no needles involved) to the head and neck area at true acupuncture points.
Sham AcupunctureProcedure or surgery
Delivery of four acupuncture seeds (no needles involved) to the head and neck area at non-acupuncture points.
| Study group | Role | What they receive |
|---|---|---|
| True Acupuncture | Experimental | Not described Receives: Procedure: True Acupuncture |
| Sham Acupuncture | Sham comparator | Not described Receives: Procedure: Sham Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Change in mean arterial blood pressure, as measured by blood pressure cuff in sitting position
Measured: 9 weeks
Secondary outcomes (7)
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
Measured: 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
Measured: 9 weeks
Medication Dose Change
Percentage change in median dose of midodrine or fludrocortisone (in mg per week)
Measured: 9 weeks
Got off medications
Number of patients who came off of midodrine or fludrocortisone by end of study
Measured: 9 weeks
NYHA Class
Change in NYHA Class
Measured: Start, 5 weeks, and 9 weeks
Quality of Life Score
Change in Quality of Life scores by VAS
Measured: 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
Measured: Throughout study, total time 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start20 Apr 2021
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized double-blinded sham-controlled clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scripps Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Ming Ni, Scripps Health
- Investigators
- Christopher Suhar, MD, Principal investigator, Scripps HealthYu-Ming Ni, MD, Principal investigator, Scripps HealthRajeev Mohan, MD, Principal investigator, Scripps Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04952935
- Sponsor's protocol ID
- IRB-20-7569
- Status last verified
- Jul 2021
- First submitted
- 21 May 2021
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for the Treatment of Medication-Dependent Hypotension in Heart Failure
- ClinicalTrials.gov ID
- NCT04952935
- Acronym / sponsor ID
- IRB-20-7569
- Conditions
- Congestive Heart Failure, Hypotension
- Keywords
- acupuncture, midodrine, fludrocortisone, randomized controlled trial
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Scripps HealthUniversity, hospital or other
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 7 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized double-blinded sham-controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| True Acupuncture | Experimental | Procedure: True Acupuncture |
| Sham Acupuncture | Sham comparator | Procedure: Sham Acupuncture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| True AcupunctureDelivery of four acupuncture seeds (no needles involved) to the head and neck area at true acupuncture points. | Procedure or surgery | True Acupuncture |
| Sham AcupunctureDelivery of four acupuncture seeds (no needles involved) to the head and neck area at non-acupuncture points. | Procedure or surgery | Sham Acupuncture |
Primary outcome
Blood Pressure
Time frame: 9 weeks
Change in mean arterial blood pressure, as measured by blood pressure cuff in sitting position
7 secondary outcomes
Blood Pressure adjusted for Medication
Time frame: 9 weeks
Standing Blood Pressure adjusted for Medication
Time frame: 9 weeks
Medication Dose Change
Time frame: 9 weeks
Got off medications
Time frame: 9 weeks
NYHA Class
Time frame: Start, 5 weeks, and 9 weeks
Quality of Life Score
Time frame: Start, 5 weeks, and 9 weeks
Composite Safety Outcome
Time frame: Throughout study, total time 9 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Suhar, MD contact
Christopher Suhar, MD principal investigator
Scripps Health
Yu-Ming Ni, MD principal investigator
Scripps Health
Rajeev Mohan, MD principal investigator
Scripps Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing True Acupuncture in people with Congestive Heart Failure and Hypotension, run by Scripps Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Ming Ni, MD (858-554-3360, acupunctureHF@scrippshealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (time frame: 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2021.