Cardiovascular DiseasesNCT06241534
Supporting Methods in Cardiovascular Diseases Rehabilitation
A study testing Cardiac rehabilitation, Relaxation-therapeutic recordings and Virtual reality therapy in people with Cardiovascular Diseases and Coronary Artery Disease, run by Wroclaw University of Health and Sport Sciences at 1 site in Poland.
Trial summary
The study evaluates how various therapeutic approaches perform in addressing depression, anxiety symptoms, and stress levels among patients in the second stage of cardiac rehabilitation. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Cardiovascular Diseases, Coronary Artery Disease, Mood Disorders
- What is being tested?
- Cardiac rehabilitation, Relaxation-therapeutic recordings and Virtual reality therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 sitePoland
- Study dates
- 1 Feb 2024to 31 May 2024
- Phase
- Interventional
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Coronary Artery Disease;
- the second stage of cardiac rehabilitation conducted in outpatient settings
Who cannot join
- inability to self-complete the research questionnaires;
- presence of the following issues at the time of the examination or in the medical data: disturbances of consciousness, psychotic symptoms or other serious psychiatric disorders;
- initiation of psychiatric treatment during the research project;
- contraindications for virtual therapy (epilepsy, vertigo, eyesight impairment);
- the patient's refusal at any stage of the research project.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effectiveness of Modern Technologies in Psychologically-enhanced Rehabilitation in Patients With Cardiovascular Diseases
The study evaluates how various therapeutic approaches perform in addressing depression, anxiety symptoms, and stress levels among patients in the second stage of cardiac rehabilitation. This study aims to evaluate the influence of the used therapeutic approaches on psychological outcomes and to compare the effectiveness of these therapies.
Read the detailed description
Depression, anxiety, and high levels of perceived stress are increasingly common problems associated with cardiovascular disease (CVD). The relationship between anxiety-depressive disorders and the risk of CVD is confirmed by behavioral and physiological mechanisms. According to the American Heart Association, depression is a negative prognostic factor at all stages of treatment of CVD. The most important risks in people with CVD and anxiety-depressive disorders, as comorbidities, are an increased risk of recurrent cardiovascular events and increased mortality. However, psychological disorders in patients with CVD are still not sufficiently diagnosed and, consequently, are not adequately treated. Therefore, it is necessary to look for effective methods to support cardiac rehabilitation from a psychological perspective.
The first group of patients will receive relaxation-therapeutic recordings (referred to as the Recording Group) in addition to monitored cardiac physical training. The second group will receive virtual reality (VR) therapy (referred to as the VR Group) alongside monitored cardiac physical training. The third group (referred to as the Control Group) will receive Schultz Autogenic Training as a standard supplement to cardiological training.
The aims of the study:
- The evaluation of the influence of relaxation-therapeutic recordings on the anxiety-depressive symptoms and the stress level of the patients undergoing second stage of cardiac rehabilitation.
- The comparison of the effectiveness of therapeutic recordings with the effectiveness of VR therapy and Schultz Autogenic Training.
- Conditions
- Cardiovascular Diseases, Coronary Artery Disease, Mood Disorders, Depressive Symptoms, Anxiety, Stress
- Being tested
- Cardiac rehabilitation, Relaxation-therapeutic recordings, Virtual reality therapy, Schultz Autogenic Training
- Keywords
- cardiac rehabilitation, psychotherapy, therapeutic recordings, virtual reality, depression, anxiety, stress
- Medical subject headings
- Cardiovascular Diseases, Coronary Artery Disease, Mood Disorders, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac rehabilitationBehavioural
Four weeks of cardiac rehabilitation conducted in an outpatient care facility. Three times per week (80 minutes per day) cardiologically monitored aerobic training consisting of: 40 minutes of interval training on a cycloergometer and 40 minutes of general fitness exercises.
Relaxation-therapeutic recordingsBehavioural
8 sessions of relaxation-therapeutic recordings in the non-sleep deep rest concept.
The content of the recording is based on the 'body scanning technique', which constitutes the core of the therapy. This approach aims to quiet the overactive sympathetic part of the autonomic nervous system. During therapy, the patients take a 'journey' through their own body from feet to head. Following the voice of the narrator, the patient focuses on specific body parts, tries to feel this place and then relaxes tense muscles. Relaxation of individual body parts (muscle groups) is combined with breathing exercises. Conscious and mindful breathing deepens the state of relaxation. Additionally, the recording includes therapeutic suggestions related to making a choice between: overload and relief, holding on and letting go, acting and sensing. Furthermore, suggestions focus the patient on inner wisdom that allows them to make the best decisions.
Virtual reality therapyDevice
8 sessions of VR therapy (each of them 20 minutes long). As a virtual reality source, VR TierOne device (Stolgraf®) were used. Thanks to using head mounted display and the phenomenon of total immersion VR therapy provides an intense visual, auditory and kinesthetic stimulation. It can have a calming and mood-improving effect or help the patients recognize their psychological resources and motivate to the rehabilitation process. In the virtual therapeutic garden there are a rich set of symbols and metaphors based on Ericksonian Psychotherapy approach.The most important is the Garden of Revival which symbolizes the patient's health. It used to be full of life and energy, now it is neglected, requires work to be revived. In the therapeutic process day by day, the therapist tells the patient a symbolic story about his/her situation.
Schultz Autogenic TrainingBehavioural
8 sessions of Schultz Autogenic Training (each of them 20 minutes long).
| Study group | Role | What they receive |
|---|---|---|
| Recordings Group | Experimental | Cardiac rehabilitation supplemented by relaxation-therapeutic recordings Receives: Behavioral: Cardiac rehabilitation; Behavioral: Relaxation-therapeutic recordings |
| VR Group | Experimental | Cardiac rehabilitation supplemented by VR therapy Receives: Behavioral: Cardiac rehabilitation; Device: Virtual reality therapy |
| Control Group | Active comparator | Cardiac rehabilitation supplemented by Schultz Autogenic Training Receives: Behavioral: Cardiac rehabilitation; Behavioral: Schultz Autogenic Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Anxiety and Depression Scale Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression Scale (HADS) is a fourteen-item scale scoring from 0 to 3 for each item. The first seven items relate to anxiety (HADS-A), and the remaining seven items relate to depression (HADS-D). The global scoring ranges from 0 to 42 with a cut-off point of 8/21 for anxiety and 8/21 for depression. The higher the score, the greater anxiety or depression symptoms. HADS will be performed at the beginning and after four weeks of treatment.
Measured: 15 minutes
Perception of Stress Questionnaire
The Perception of Stress Questionnaire (PSQ) was created by Plopa and Makarowski. It is a 27-item scale scoring from 1 to 5 points for each item, where 21 items examine the level of stress in the areas of emotional tension, external stress and intrapsychic stress, and six items refer to the lie scale. The global scoring for the perception of stress ranges from 21 to 105, with a cut-off point of 60 for an elevated level of perceived stress. Higher scores indicate higher stress perception.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start1 Feb 2024
- Primary completion15 Apr 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wroclaw University of Health and Sport Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Gajda-Med District Hospital, Cardiology Center Pro Corde, Healthcare Innovation Technology Lab, IRCCS San Camillo Hospital
- Responsible party
- Principal investigator, Adam Wrzeciono, MSc, Wroclaw University of Health and Sport Sciences
- Investigators
- Joanna Szczepańska-Gieracha, Prof., Study director, Wroclaw University of Health and Sport SciencesAdam Wrzeciono, MSc., Principal investigator, Wroclaw University of Health and Sport SciencesSandra Jóźwik, Ph.D., Principal investigator, Cardiology Center Pro CordeBłażej Cieślik, Ph.D., Study chair, Healthcare Innovation Technology Lab, IRCCS San Camillo HospitalPaweł Kiper, Ph.D., Study chair, Healthcare Innovation Technology Lab, IRCCS San Camillo HospitalRobert Gajda, Prof., Study director, Gajda-Med District Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06241534
- Sponsor's protocol ID
- RCT/CR/01/2023
- Status last verified
- Jul 2024
- First submitted
- 26 Jan 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Natt Och Dag Y, Mehlig K, Rosengren A, Lissner L, Rosvall M. Negative emotional states and negative life events: Consequences for cardiovascular health in a general population. J Psychosom Res. 2020 Feb;129:109888. doi: 10.1016/j.jpsychores.2019.109888. Epub 2019 Nov 29.
PubMed 31835155Silverman AL, Herzog AA, Silverman DI. Hearts and Minds: Stress, Anxiety, and Depression: Unsung Risk Factors for Cardiovascular Disease. Cardiol Rev. 2019 Jul/Aug;27(4):202-207. doi: 10.1097/CRD.0000000000000228.
PubMed 30130257Szczepanska-Gieracha J, Morka J, Kowalska J, Kustrzycki W, Rymaszewska J. The role of depressive and anxiety symptoms in the evaluation of cardiac rehabilitation efficacy after coronary artery bypass grafting surgery. Eur J Cardiothorac Surg. 2012 Nov;42(5):e108-14. doi: 10.1093/ejcts/ezs463. Epub 2012 Aug 19.
PubMed 22906598Szczepanska-Gieracha J, Jozwik S, Cieslik B, Mazurek J, Gajda R. Immersive Virtual Reality Therapy as a Support for Cardiac Rehabilitation: A Pilot Randomized-Controlled Trial. Cyberpsychol Behav Soc Netw. 2021 Aug;24(8):543-549. doi: 10.1089/cyber.2020.0297. Epub 2021 Feb 11.
PubMed 33577375Jozwik S, Cieslik B, Gajda R, Szczepanska-Gieracha J. Evaluation of the Impact of Virtual Reality-Enhanced Cardiac Rehabilitation on Depressive and Anxiety Symptoms in Patients with Coronary Artery Disease: A Randomised Controlled Trial. J Clin Med. 2021 May 16;10(10):2148. doi: 10.3390/jcm10102148.
PubMed 34065625Jozwik S, Cieslik B, Gajda R, Szczepanska-Gieracha J. The Use of Virtual Therapy in Cardiac Rehabilitation of Female Patients with Heart Disease. Medicina (Kaunas). 2021 Jul 28;57(8):768. doi: 10.3390/medicina57080768.
PubMed 34440974Jozwik S, Wrzeciono A, Cieslik B, Kiper P, Szczepanska-Gieracha J, Gajda R. The Use of Virtual Therapy in Cardiac Rehabilitation of Male Patients with Coronary Heart Disease: A Randomized Pilot Study. Healthcare (Basel). 2022 Apr 16;10(4):745. doi: 10.3390/healthcare10040745.
PubMed 35455922
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Modern Technologies in Psychologically-enhanced Rehabilitation in Patients With Cardiovascular Diseases
- ClinicalTrials.gov ID
- NCT06241534
- Acronym / sponsor ID
- RCT/CR/01/2023
- Conditions
- Cardiovascular Diseases, Coronary Artery Disease, Mood Disorders, Depressive Symptoms, Anxiety, Stress
- Keywords
- cardiac rehabilitation, psychotherapy, therapeutic recordings, virtual reality, depression, anxiety, stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Wroclaw University of Health and Sport SciencesUniversity, hospital or other
- Collaborators
- Gajda-Med District Hospital, Cardiology Center Pro Corde, Healthcare Innovation Technology Lab, IRCCS San Camillo Hospital
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 5 Feb 2024 (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.
The study evaluates how various therapeutic approaches perform in addressing depression, anxiety symptoms, and stress levels among patients in the second stage of cardiac rehabilitation. This study aims to evaluate the influence of the used therapeutic approaches on psychological outcomes and to compare the effectiveness of these therapies.
Detailed description
Depression, anxiety, and high levels of perceived stress are increasingly common problems associated with cardiovascular disease (CVD). The relationship between anxiety-depressive disorders and the risk of CVD is confirmed by behavioral and physiological mechanisms. According to the American Heart Association, depression is a negative prognostic factor at all stages of treatment of CVD. The most important risks in people with CVD and anxiety-depressive disorders, as comorbidities, are an increased risk of recurrent cardiovascular events and increased mortality. However, psychological disorders in patients with CVD are still not sufficiently diagnosed and, consequently, are not adequately treated. Therefore, it is necessary to look for effective methods to support cardiac rehabilitation from a psychological perspective.
The first group of patients will receive relaxation-therapeutic recordings (referred to as the Recording Group) in addition to monitored cardiac physical training. The second group will receive virtual reality (VR) therapy (referred to as the VR Group) alongside monitored cardiac physical training. The third group (referred to as the Control Group) will receive Schultz Autogenic Training as a standard supplement to cardiological training.
The aims of the study:
- The evaluation of the influence of relaxation-therapeutic recordings on the anxiety-depressive symptoms and the stress level of the patients undergoing second stage of cardiac rehabilitation.
- The comparison of the effectiveness of therapeutic recordings with the effectiveness of VR therapy and Schultz Autogenic Training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Recordings Group | Experimental | Behavioral: Cardiac rehabilitation, Behavioral: Relaxation-therapeutic recordingsCardiac rehabilitation supplemented by relaxation-therapeutic recordings |
| VR Group | Experimental | Behavioral: Cardiac rehabilitation, Device: Virtual reality therapyCardiac rehabilitation supplemented by VR therapy |
| Control Group | Active comparator | Behavioral: Cardiac rehabilitation, Behavioral: Schultz Autogenic TrainingCardiac rehabilitation supplemented by Schultz Autogenic Training |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Coronary Artery Disease;
- the second stage of cardiac rehabilitation conducted in outpatient settings
Key exclusion criteria (5 listed)
- inability to self-complete the research questionnaires;
- presence of the following issues at the time of the examination or in the medical data: disturbances of consciousness, psychotic symptoms or other serious psychiatric disorders;
- initiation of psychiatric treatment during the research project;
- contraindications for virtual therapy (epilepsy, vertigo, eyesight impairment);
- the patient's refusal at any stage of the research project.
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 |
|---|---|---|
| Cardiac rehabilitationFour weeks of cardiac rehabilitation conducted in an outpatient care facility. Three times per week (80 minutes per day) cardiologically monitored aerobic training consisting of: 40 minutes of interval training on a cycloergometer and 40 minutes of general fitness exercises. | Behavioural | Control Group, Recordings Group, VR Group |
| Relaxation-therapeutic recordings8 sessions of relaxation-therapeutic recordings in the non-sleep deep rest concept. The content of the recording is based on the 'body scanning technique', which constitutes the core of the therapy. This approach aims to quiet the overactive sympathetic part of the autonomic nervous system. During therapy, the patients take a 'journey' through their own body from feet to head. Following the voice of the narrator, the patient focuses on specific body parts, tries to feel this place and then relaxes tense muscles. Relaxation of individual body parts (muscle groups) is combined with breathing exercises. Conscious and mindful breathing deepens the state of relaxation. Additionally, the recording includes therapeutic suggestions related to making a choice between: overload and relief, holding on and letting go, acting and sensing. Furthermore, suggestions focus the patient on inner wisdom that allows them to make the best decisions. | Behavioural | Recordings Group |
| Virtual reality therapy8 sessions of VR therapy (each of them 20 minutes long). As a virtual reality source, VR TierOne device (Stolgraf®) were used. Thanks to using head mounted display and the phenomenon of total immersion VR therapy provides an intense visual, auditory and kinesthetic stimulation. It can have a calming and mood-improving effect or help the patients recognize their psychological resources and motivate to the rehabilitation process. In the virtual therapeutic garden there are a rich set of symbols and metaphors based on Ericksonian Psychotherapy approach.The most important is the Garden of Revival which symbolizes the patient's health. It used to be full of life and energy, now it is neglected, requires work to be revived. In the therapeutic process day by day, the therapist tells the patient a symbolic story about his/her situation. | Device | VR Group |
| Schultz Autogenic Training8 sessions of Schultz Autogenic Training (each of them 20 minutes long). | Behavioural | Control Group |
Primary outcome
Hospital Anxiety and Depression Scale Hospital Anxiety and Depression Scale
Time frame: 15 minutes
The Hospital Anxiety and Depression Scale (HADS) is a fourteen-item scale scoring from 0 to 3 for each item. The first seven items relate to anxiety (HADS-A), and the remaining seven items relate to depression (HADS-D). The global scoring ranges from 0 to 42 with a cut-off point of 8/21 for anxiety and 8/21 for depression. The higher the score, the greater anxiety or depression symptoms. HADS will be performed at the beginning and after four weeks of treatment.
Perception of Stress Questionnaire
Time frame: 20 minutes
The Perception of Stress Questionnaire (PSQ) was created by Plopa and Makarowski. It is a 27-item scale scoring from 1 to 5 points for each item, where 21 items examine the level of stress in the areas of emotional tension, external stress and intrapsychic stress, and six items refer to the lie scale. The global scoring for the perception of stress ranges from 21 to 105, with a cut-off point of 60 for an elevated level of perceived stress. Higher scores indicate higher stress perception.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Background: PubMed 31835155Natt Och Dag Y, Mehlig K, Rosengren A, Lissner L, Rosvall M. Negative emotional states and negative life events: Consequences for cardiovascular health in a general population. J Psychosom Res. 2020 Feb;129:109888. doi: 10.1016/j.jpsychores.2019.109888. Epub 2019 Nov 29.
- Background: PubMed 30130257Silverman AL, Herzog AA, Silverman DI. Hearts and Minds: Stress, Anxiety, and Depression: Unsung Risk Factors for Cardiovascular Disease. Cardiol Rev. 2019 Jul/Aug;27(4):202-207. doi: 10.1097/CRD.0000000000000228.
- Background: PubMed 22906598Szczepanska-Gieracha J, Morka J, Kowalska J, Kustrzycki W, Rymaszewska J. The role of depressive and anxiety symptoms in the evaluation of cardiac rehabilitation efficacy after coronary artery bypass grafting surgery. Eur J Cardiothorac Surg. 2012 Nov;42(5):e108-14. doi: 10.1093/ejcts/ezs463. Epub 2012 Aug 19.
- Background: PubMed 33577375Szczepanska-Gieracha J, Jozwik S, Cieslik B, Mazurek J, Gajda R. Immersive Virtual Reality Therapy as a Support for Cardiac Rehabilitation: A Pilot Randomized-Controlled Trial. Cyberpsychol Behav Soc Netw. 2021 Aug;24(8):543-549. doi: 10.1089/cyber.2020.0297. Epub 2021 Feb 11.
- Background: PubMed 34065625Jozwik S, Cieslik B, Gajda R, Szczepanska-Gieracha J. Evaluation of the Impact of Virtual Reality-Enhanced Cardiac Rehabilitation on Depressive and Anxiety Symptoms in Patients with Coronary Artery Disease: A Randomised Controlled Trial. J Clin Med. 2021 May 16;10(10):2148. doi: 10.3390/jcm10102148.
- Background: PubMed 34440974Jozwik S, Cieslik B, Gajda R, Szczepanska-Gieracha J. The Use of Virtual Therapy in Cardiac Rehabilitation of Female Patients with Heart Disease. Medicina (Kaunas). 2021 Jul 28;57(8):768. doi: 10.3390/medicina57080768.
- Background: PubMed 35455922Jozwik S, Wrzeciono A, Cieslik B, Kiper P, Szczepanska-Gieracha J, Gajda R. The Use of Virtual Therapy in Cardiac Rehabilitation of Male Patients with Coronary Heart Disease: A Randomized Pilot Study. Healthcare (Basel). 2022 Apr 16;10(4):745. doi: 10.3390/healthcare10040745.
- Individual participant dataSharing planned: No
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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.
Joanna Szczepańska-Gieracha, Prof. study director
Wroclaw University of Health and Sport Sciences
Adam Wrzeciono, MSc. principal investigator
Wroclaw University of Health and Sport Sciences
Sandra Jóźwik, Ph.D. principal investigator
Cardiology Center Pro Corde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac rehabilitation, Relaxation-therapeutic recordings and Virtual reality therapy in people with Cardiovascular Diseases and Coronary Artery Disease, run by Wroclaw University of Health and Sport Sciences at 1 site in Poland.
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 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: finished, as of the sponsor's last update on 11 Jul 2024. 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 Poland. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hospital Anxiety and Depression Scale Hospital Anxiety and Depression Scale (time frame: 15 minutes). The study lists 2 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 NCT06241534, which also lists 7 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 11 Jul 2024.