Cardiovascular DiseasesNCT04121741
Singing and Cardiovascular Health in Older Adults
A study testing Singing with Music Therapist and Singing with Guided Video in people with Cardiovascular Diseases and Cardiovascular Risk Factor, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
Cardiovascular disease (CVD) claims more lives each year than cancer and chronic respiratory disease combined. Participation in cardiac rehabilitation (CR) reduces mortality and risk of a major cardiovascular event in secondary prevention populations, including older adults. Read more about this study
- Who is it for?
- Ages 55 to 79 years
- Conditions the study is for
- Cardiovascular Diseases, Cardiovascular Risk Factor, Cardiovascular Health
- What is being tested?
- Singing with Music Therapist and Singing with Guided Video
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2020to 18 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English Speaking
- Have a history of coronary artery disease (defined as history of myocardial infarction, coronary stenosis >50%, percutaneous coronary intervention with stent placement, balloon angioplasty, or coronary arterial bypass grafting)
Who cannot join
- Subjects with a permanent pacemaker or implantable cardioverter defibrillator (ICD) implanted
- Patients with a history of atrial fibrillation, flutter or atrial tachycardia
- Parkinson's disease or a tremor
- Amputated upper extremity or presence of upper-arm (dialysis) fistula
- Fingernail onychomycosis (fungal infections resulting in thickening of the nails)
- Pregnancy
Show all 14Show fewer
- Current illicit drug use (marijuana, tobacco, cocaine, amphetamines, etc.)
- Current excessive alcohol use (defined as more than 14 drinks/week for women, more than 28 drinks/week for men)
- Unstable coronary heart disease (active symptoms of chest discomfort)
- History of a Stroke or TIA or peripheral arterial disease
- Known history of cognitive impairment or inability to follow study procedures
- Cancer requiring systemic treatment within five years of enrollment.
- Subjects requiring supplemental oxygen use
- Non-English speaking subjects (video with lyrics are taped in English)
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Evaluating the Impact of Singing Interventions on Markers of Cardiovascular Health in Older Patients With Cardiovascular Disease
Cardiovascular disease (CVD) claims more lives each year than cancer and chronic respiratory disease combined. Participation in cardiac rehabilitation (CR) reduces mortality and risk of a major cardiovascular event in secondary prevention populations, including older adults. Older adults are less likely to participate in CR, as comorbidities in this population, including arthritis and chronic obstructive pulmonary disease, make participation difficult. Singing is a physical activity that involves components of the vagal nerves manifested as changes in cardiac autonomic regulation. Unlike physical exercise, the effects of singing on cardiovascular health has not been well-studied. The hypothesis for this project is that older patients with CVD will have favorable improvement in cardiovascular biomarkers, including, endothelial function and heart rate variability (HRV), after 30 minutes of singing.
Read the detailed description
This proposal seeks to create, optimize and test two different singing interventions in older patients with CVD. The study will consist of three arms, according to a randomized, single-blind, crossover, sham procedure-controlled design. Sixty-five total participants will each have three visits on three different occasions for the following interventions:
- a 30-minute period of guided singing from an in-person music therapist
- a 30-minute period of singing along to an instructional video including a professor of voice and "inexperienced, older singing student"
- a 30-minute sham intervention (subjects will undergo a hearing test)
The goal will be to determine which singing intervention, if any, is superior to the other - as this would be important to guide longer and larger clinical trials in the field. Knowledge gained from this proposal will improve understanding of biologic mechanisms of singing behaviors, as it relates to CVD.
- Being tested
- Singing with Music Therapist, Singing with Guided Video, Control Arm
- Keywords
- Singing
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Singing with Music TherapistOther
Music therapy sessions will begin with vocal and breathing warm-up exercises for about 10 minutes. The Music Therapist will play the songs (chosen from a list by the subject) to sing along to and will alter the characteristics of the music (volume, tempo, level of support) to ensure a successful experience for subjects and motivate them to put forth more effort into singing the song. The music therapist will continue to coach throughout the 30-minute session, reminding subjects of strategies practiced and how to implement those strategies while singing. Music therapy sessions will be led by Erica Flores, MT-BC, WMTR, Owner of Healing Harmonies Music Therapy, or a member of her team. Erica and her team of MTs were trained in Neurological Music Therapy.
Singing with Guided VideoOther
The videos will include a vocal warm-up (10 minutes long). The subject will then have the option to select and sing two songs (10 minutes each), with offerings in four music genres including Folk, Pop, Country, and a Hymn. Each piece will vary in tempo, melodic contour, and rhythm. The total duration of singing via this format will be 30 minutes.
Control ArmOther
30 minute rest period, no singing will take place during this arm. During this rest period a member of the study team will assist the subject in a hearing test using headphones, a tablet, and a trumpet app. This is done to asses the current hearing level of the subject.
| Study group | Role | What they receive |
|---|---|---|
| Singing intervention 1 | Active comparator | Instructional sing-a-long video. A video series will be created and recorded for the purposes of the study. Flow Mediated dilation (FMD) and EndoPAT will be measured before and after singing. Receives: Other: Singing with Guided Video |
| Singing intervention 2 | Active comparator | In-person music therapy session. The music therapist will continue to coach throughout the 30-minute session. Flow Mediated dilation (FMD) and EndoPAT will be measured before and after singing. Receives: Other: Singing with Music Therapist |
| Control/sham intervention | Sham comparator | Subjects will have a 30-minute period of rest sitting upright (as they would be positioned for the singing interventions). This arm is meant to isolate the specific effects of the treatment rather than the potential "incidental" effects related to the research setting and measurements. During this time, subjects will undergo hearing testing. Flow Mediated dilation (FMD) and EndoPAT will be measured before and after the 30 minute rest. Receives: Other: Control Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FMD%
Assess macrovascular endothelial function by assessing changes in post-intervention to pre-intervention changes in brachial artery FMD%.
Measured: At baseline and after 30-minute singing and control intervention(s)
Change in Reactive Hyperemia Index (RHI)
Assess microvascular endothelial function by measuring changes in reactive hyperemia index through finger plethysmography using EndoPAT. A larger post-intervention to pre-intervention change in RHI is considered a better outcome.
Measured: At baseline and after 30-minute singing and control intervention(s)
Change in Framingham Reactive Hyperemia Index (fRHI)
Assess microvascular endothelial function by measuring changes in Framingham reactive hyperemia index through finger plethysmography using EndoPAT. A larger post-intervention to pre-intervention change in fRHI is considered a better outcome.
Measured: At baseline and after 30-minute singing and control intervention(s)
Secondary outcomes (7)
BORG Rating of Perceived Exertion
The BORG RPE scale assesses an individual's perceived level of exertion. It ranges from 6 to 20, whereas 6 reflects no exertion at all and 20 reflects maximal exertion.
Measured: after 30-minute singing (and sham) interventions
Change in SDNN (Standard Deviation of Normal-to-Normal Intervals)
Heart rate variability is assessed using SDNN (Standard Deviation of Normal-to-Normal intervals) before, during, and post-intervention. Reported as percent change compared to the baseline (pre) value. Percent change calculated as 100*[(post-pre)/pre] or 100*[(during-pre)/pre].
An appropriately sized (Bluetooth-capable) chest strap (Polar, Kempele, Finland) with a heart rate sensor was applied to the subject's bare chest. Three-minute-long HRV recordings were obtained before, during, and after singing (or rest control).
Measured: at baseline (pre), during, and after (post) 30-minute singing and sham intervention(s)
Change in RMSSD (Root Mean Square of Successive Differences)
Heart rate variability is assessed using (RMSSD) root mean square of successive differences before, during, and post-intervention. Reported as percent change compared to the baseline (pre) value. Percent change calculated as 100*[(post-pre)/pre] or 100*[(during-pre)/pre].
An appropriately sized (Bluetooth-capable) chest strap (Polar, Kempele, Finland) with a heart rate sensor was applied to the subject's bare chest. Three-minute-long HRV recordings were obtained before, during, and after singing (or rest control).
Measured: at baseline (pre), during, and after (post) 30-minute singing and sham intervention(s)
Change in HF Power (High-frequency Power)
Heart rate variability is assessed using high-frequency power (HF Power) before, during and post-intervention. Reported as an absolute change or difference compared to baseline (pre). Unit of measurement is milliseconds-squared. Power in the High Frequency band of the HRV spectrum falls between 0.15-0.40 Hz. The actual activity in that band is typically expressed in terms of "power", which uses the units of milliseconds-squared for a particular Hertz (Hz) band. Think of it as an "area under the curve".
An appropriately sized (Bluetooth-capable) chest strap (Polar, Kempele, Finland) with a heart rate sensor was applied to the subject's bare chest. Three-minute-long HRV recordings were obtained before, during, and after singing (or rest control).
Measured: at baseline (pre), during, and after (post) 30-minute singing and sham intervention(s)
Change in LF Power (Low-frequency Power)
Heart rate variability is assessed using low-frequency power (LF Power) before, during and post-intervention. Reported as an absolute change or difference compared to baseline (pre). Unit of measurement is milliseconds-squared. Power in the Low Frequency band of the HRV spectrum is defined as greater than 0.00 Hz and less than 0.04 Hz. The actual activity in that band is typically expressed in terms of "power", which uses the units of milliseconds-squared for a particular Hertz (Hz) band. Think of it as an "area under the curve".
An appropriately sized (Bluetooth-capable) chest strap (Polar, Kempele, Finland) with a heart rate sensor was applied to the subject's bare chest. Three-minute-long HRV recordings were obtained before, during, and after singing (or rest control).
Measured: at baseline (pre), during, and after (post) 30-minute singing and sham intervention(s)
Change in LF/HF Ratio (Low-frequency to High-frequency Ratio)
Heart rate variability is assessed using LF/HF ratio before, during and post-intervention. This is an (absolute) difference between ratios, so there are no units of measure.
The LF/HF ratio is as an index of sympatho-vagal balance between the sympathetic and parasympathetic nervous systems.
An appropriately sized (Bluetooth-capable) chest strap (Polar, Kempele, Finland) with a heart rate sensor was applied to the subject's bare chest. Three-minute-long HRV recordings were obtained before, during, and after singing (or rest control).
Measured: at baseline (pre), during, and after (post) 30-minute singing and sham intervention(s)
Change in LnHF Power (Natural Log (Milliseconds Squared))
Heart rate variability is assessed using LnHF Power before, during and post-intervention. The physiological range for the LnHF Power in heart rate variability is typically considered to be between 4 and 7. Reported here as an absolute change or difference in LnHF Power (natural log (milliseconds squared)). Under controlled conditions while breathing at normal rates, we can use LnHF Power to estimate vagal tone.
Interpreting results:
Higher natural log HF power: Indicates greater parasympathetic activity, often associated with relaxation and a healthy stress response.
Lower natural log HF power: May suggest decreased parasympathetic activity, potentially related to stress or other physiological factors.
An appropriately sized (Bluetooth-capable) chest strap (Polar, Kempele, Finland) with a heart rate sensor was applied to the subject's bare chest. Three-minute-long HRV recordings were obtained before, during, and after singing (or rest control).
Measured: at baseline (pre), during, and after (post) 30-minute singing and sham intervention(s)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start17 Jan 2020
- Primary completion18 Aug 2023
- Study completion18 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Jacquelyn Kulinski, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04121741
- Sponsor's protocol ID
- 35864
- Other IDs
- R33AT010680
- Status last verified
- Jan 2025
- First submitted
- 7 Oct 2019
- Last updated
- 5 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bagherimohamadipour M, Hammad M, Visotcky A, Sparapani R, Kulinski J. Effects of singing on vascular health in older adults with coronary artery disease: a randomized, crossover trial. Front Cardiovasc Med. 2025 Apr 28;12:1546462. doi: 10.3389/fcvm.2025.1546462. eCollection 2025.
PubMed 40357442Bagherimohamadipour M, Hammad M, Visotcky A, Sparapani R, Kulinski J. Effects of Singing on Vascular Health in Older Adults with Coronary Artery Disease: A Randomized Trial. medRxiv [Preprint]. 2024 Jul 27:2024.07.25.24311033. doi: 10.1101/2024.07.25.24311033.
PubMed 39108506
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Singing Interventions on Markers of Cardiovascular Health in Older Patients With Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT04121741
- Acronym / sponsor ID
- 35864
- Keywords
- Singing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 17 Jan 2020 (actual)
- Primary completion
- 18 Aug 2023 (actual)
- Study completion
- 18 Aug 2023 (actual)
- First posted
- 10 Oct 2019 (actual)
- Results
- Posted 5 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cardiovascular disease (CVD) claims more lives each year than cancer and chronic respiratory disease combined. Participation in cardiac rehabilitation (CR) reduces mortality and risk of a major cardiovascular event in secondary prevention populations, including older adults. Older adults are less likely to participate in CR, as comorbidities in this population, including arthritis and chronic obstructive pulmonary disease, make participation difficult. Singing is a physical activity that involves components of the vagal nerves manifested as changes in cardiac autonomic regulation. Unlike physical exercise, the effects of singing on cardiovascular health has not been well-studied. The hypothesis for this project is that older patients with CVD will have favorable improvement in cardiovascular biomarkers, including, endothelial function and heart rate variability (HRV), after 30 minutes of singing.
Detailed description
This proposal seeks to create, optimize and test two different singing interventions in older patients with CVD. The study will consist of three arms, according to a randomized, single-blind, crossover, sham procedure-controlled design. Sixty-five total participants will each have three visits on three different occasions for the following interventions:
- a 30-minute period of guided singing from an in-person music therapist
- a 30-minute period of singing along to an instructional video including a professor of voice and "inexperienced, older singing student"
- a 30-minute sham intervention (subjects will undergo a hearing test)
The goal will be to determine which singing intervention, if any, is superior to the other - as this would be important to guide longer and larger clinical trials in the field. Knowledge gained from this proposal will improve understanding of biologic mechanisms of singing behaviors, as it relates to CVD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Singing intervention 1 | Active comparator | Other: Singing with Guided VideoInstructional sing-a-long video. A video series will be created and recorded for the purposes of the study. Flow Mediated dilation (FMD) and EndoPAT will be measured before and after singing. |
| Singing intervention 2 | Active comparator | Other: Singing with Music TherapistIn-person music therapy session. The music therapist will continue to coach throughout the 30-minute session. Flow Mediated dilation (FMD) and EndoPAT will be measured before and after singing. |
| Control/sham intervention | Sham comparator | Other: Control ArmSubjects will have a 30-minute period of rest sitting upright (as they would be positioned for the singing interventions). This arm is meant to isolate the specific effects of the treatment rather than the potential "incidental" effects related to the research setting and measurements. During this time, subjects will undergo hearing testing. Flow Mediated dilation (FMD) and EndoPAT will be measured before and after the 30 minute rest. |
Who may qualify
- Ages
- 55 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- English Speaking
- Have a history of coronary artery disease (defined as history of myocardial infarction, coronary stenosis >50%, percutaneous coronary intervention with stent placement, balloon angioplasty, or coronary arterial bypass grafting)
Key exclusion criteria (14 listed)
- Subjects with a permanent pacemaker or implantable cardioverter defibrillator (ICD) implanted
- Patients with a history of atrial fibrillation, flutter or atrial tachycardia
- Parkinson's disease or a tremor
- Amputated upper extremity or presence of upper-arm (dialysis) fistula
- Fingernail onychomycosis (fungal infections resulting in thickening of the nails)
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 |
|---|---|---|
| Singing with Music TherapistMusic therapy sessions will begin with vocal and breathing warm-up exercises for about 10 minutes. The Music Therapist will play the songs (chosen from a list by the subject) to sing along to and will alter the characteristics of the music (volume, tempo, level of support) to ensure a successful experience for subjects and motivate them to put forth more effort into singing the song. The music therapist will continue to coach throughout the 30-minute session, reminding subjects of strategies practiced and how to implement those strategies while singing. Music therapy sessions will be led by Erica Flores, MT-BC, WMTR, Owner of Healing Harmonies Music Therapy, or a member of her team. Erica and her team of MTs were trained in Neurological Music Therapy. | Other | Singing intervention 2 |
| Singing with Guided VideoThe videos will include a vocal warm-up (10 minutes long). The subject will then have the option to select and sing two songs (10 minutes each), with offerings in four music genres including Folk, Pop, Country, and a Hymn. Each piece will vary in tempo, melodic contour, and rhythm. The total duration of singing via this format will be 30 minutes. | Other | Singing intervention 1 |
| Control Arm30 minute rest period, no singing will take place during this arm. During this rest period a member of the study team will assist the subject in a hearing test using headphones, a tablet, and a trumpet app. This is done to asses the current hearing level of the subject. | Other | Control/sham intervention |
Primary outcome
Change in FMD%
Time frame: At baseline and after 30-minute singing and control intervention(s)
Assess macrovascular endothelial function by assessing changes in post-intervention to pre-intervention changes in brachial artery FMD%.
Change in Reactive Hyperemia Index (RHI)
Time frame: At baseline and after 30-minute singing and control intervention(s)
Assess microvascular endothelial function by measuring changes in reactive hyperemia index through finger plethysmography using EndoPAT. A larger post-intervention to pre-intervention change in RHI is considered a better outcome.
Change in Framingham Reactive Hyperemia Index (fRHI)
Time frame: At baseline and after 30-minute singing and control intervention(s)
Assess microvascular endothelial function by measuring changes in Framingham reactive hyperemia index through finger plethysmography using EndoPAT. A larger post-intervention to pre-intervention change in fRHI is considered a better outcome.
7 secondary outcomes
BORG Rating of Perceived Exertion
Time frame: after 30-minute singing (and sham) interventions
Change in SDNN (Standard Deviation of Normal-to-Normal Intervals)
Time frame: at baseline (pre), during, and after (post) 30-minute singing and sham intervention(s)
Change in RMSSD (Root Mean Square of Successive Differences)
Time frame: at baseline (pre), during, and after (post) 30-minute singing and sham intervention(s)
Change in HF Power (High-frequency Power)
Time frame: at baseline (pre), during, and after (post) 30-minute singing and sham intervention(s)
Change in LF Power (Low-frequency Power)
Time frame: at baseline (pre), during, and after (post) 30-minute singing and sham intervention(s)
Change in LF/HF Ratio (Low-frequency to High-frequency Ratio)
Time frame: at baseline (pre), during, and after (post) 30-minute singing and sham intervention(s)
Change in LnHF Power (Natural Log (Milliseconds Squared))
Time frame: at baseline (pre), during, and after (post) 30-minute singing and sham intervention(s)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40357442Bagherimohamadipour M, Hammad M, Visotcky A, Sparapani R, Kulinski J. Effects of singing on vascular health in older adults with coronary artery disease: a randomized, crossover trial. Front Cardiovasc Med. 2025 Apr 28;12:1546462. doi: 10.3389/fcvm.2025.1546462. eCollection 2025.
- Derived from this study: PubMed 39108506Bagherimohamadipour M, Hammad M, Visotcky A, Sparapani R, Kulinski J. Effects of Singing on Vascular Health in Older Adults with Coronary Artery Disease: A Randomized Trial. medRxiv [Preprint]. 2024 Jul 27:2024.07.25.24311033. doi: 10.1101/2024.07.25.24311033.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Singing with Music Therapist and Singing with Guided Video in people with Cardiovascular Diseases and Cardiovascular Risk Factor, run by Medical College of Wisconsin at 1 site 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 2 inclusion and 14 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: finished, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in FMD% (time frame: At baseline and after 30-minute singing and control intervention(s)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04121741, which also lists 2 linked publications.
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 5 Feb 2025.