Rheumatoid ArthritisRABEXNCT05215509
Exercise-induced Cardiac Adaptions in Rheumatoid Arthritis Patients During IL-6 vs. TNF Antibody Therapy
A study testing Exercise and No exercise in people with Rheumatoid Arthritis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The present study will investigative the physiological effects of the cytokines interleukin-6 (IL-6) and tumor necrosis factor (TNF) on the adaptive changes to exercise in patients with rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Exercise and No exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2021to 31 Dec 2023
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >= 18 and <70 years
- Informed consent
- Diagnosed RA based on the 2010 American College of Rheumatology/ EULAR criteria. In biological treatment with either IL-6rB og TNFi over four months prior to enrollment
- Low RA disease activity, based on the Disease Activity Score-28 ESR for Rheumatoid Arthritis (DAS28) <=3.2
- An electrocardiogram without features of left ventricular hypertrophy defined by the European Society of Cardiology
- Females of childbearing potential have to use one or more of the following highly effective methods for contraception in order to be included:
Show all 16Show fewer
- Vasectomized partner
- Bilateral tubal occlusion
- Sexual abstinence
- Intrauterine device
- Hormonal contraception
- Females who are considered to have no childbearing potential are
- Bilateral tubal ligation
- Bilateral oophorectomy
- Complete hysterectomy
- Postmenopausal defined as 12 months with no menses without an alternative medical cause
Who cannot join
- Health conditions that prevent participating in the exercise intervention determined by the Project Coordinator
- Subjects who cannot undergo MRI scans (metallic implants or claustrophobia)
- Corticosteroid use per os > 10 mg/day within seven days of study enrollment
- Intramuscular corticosteroid within 3 weeks of the study enrollment
- Grade 2 hypertension (systolic BP > 160 mmHg and/or diastolic BP >100 mmHg) despite the use of antihypertensive drugs.
- Pregnancy
- Subjects with insulin dependent Diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exercise-induced Cardiac Adaptions in Rheumatoid Arthritis Patients During Interleukin-6 vs. Tumor Necrosis Factor Antibody Therapy: a Randomised, Controlled Study.
The present study will investigative the physiological effects of the cytokines interleukin-6 (IL-6) and tumor necrosis factor (TNF) on the adaptive changes to exercise in patients with rheumatoid arthritis. The investigators hypothesize that blockage of IL-6 receptors will decrease the cardiac and metabolic adaptations to exercise training compared to the inhibition of TNF. 80 patients will be included in a 12-week investigator blinded randomised exercise training intervention study.
Read the detailed description
80 patients with rheumatoid arthritis who are being treated with either interleukin-6 receptor blockers (IL-6Rb) or tumor necrosis factor inhibitors (TNFi) for a minimum of four months prior to enrollment will be recruited and undergo baseline testing, including examination, biochemistry, ECG, DXA, OGTT, pulmonary function, VO2max, echocardiography, cardiac MRI.
After baseline testing, 40 patients in IL-6 receptor blocker treatment and 40 patients in TNF inhibitor treatment.will be randomly allocated into one group receiving standard of care (control group) or a group performing supervised high-intensity interval training three times a week over a period of 12 weeks. The randomization procedure involves a computer-generated block randomization schedule in a ratio of 1:1 stratified by sex by an independent person. Following the 12-week intervention period, all groups will complete a series of follow-up tests (as baseline testing).
- Conditions
- Rheumatoid Arthritis
- Being tested
- Exercise, No exercise
- Keywords
- Cardiac adaptations, Metabolic adaptations, High intensity interval training
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Also called High intensity interval training
Supervised high-intensity interval training for 12 weeks three times per week. The supervision may be physical or online supervision
No exerciseBehavioural
Control group, therefore no supervised exercise regime
| Study group | Role | What they receive |
|---|---|---|
| RA patients TNFi Exercise | Experimental | The patients will be randomized to 12-week supervised exercise training intervention or no exercise training. The exercise training program includes three supervised sessions per week over a 12-week period.
The program consists of high intensity endurance training on ergometer bicycles. The intensity will progress throughout the 12 weeks of training. The training consists of 10 minutes of warm up at 40-60% maximum heart rate (HRmax), followed by 25 minutes of high intensity interval training (4 bouts of 4 min at >85% HRmax interspaced by 3 minutes of low intensity training at 40-60% Hrmax) and finally a 5 min cool-down of 50% Hrmax Receives: Behavioral: Exercise |
| RA patients TNFi Control | Active comparator | This group will be allocated to "control" and therefore no supervised exercise regimen Receives: Behavioral: No exercise |
| RA patients IL-6Rb Exercise | Experimental | The patients will be randomized to 12-week supervised exercise training intervention or no exercise training. The exercise training program includes three supervised sessions per week over a 12-week period.
The program consists of high intensity endurance training on ergometer bicycles. The intensity will progress throughout the 12 weeks of training. The training consists of 10 minutes of warm up at 40-60% maximum heart rate (HRmax), followed by 25 minutes of high intensity interval training (4 bouts of 4 min at >85% HRmax interspaced by 3 minutes of low intensity training at 40-60% Hrmax) and finally a 5 min cool-down of 50% Hrmax Receives: Behavioral: Exercise |
| RA patients IL-6Rb Control | Active comparator | This group will be allocated to "control" and therefore no supervised exercise regimen Receives: Behavioral: No exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in left ventricular mass
measured by MRI scan
Measured: 12 weeks
Secondary outcomes (32)
Visceral adipose tissue mass
measured by MRI scan
Measured: 12 weeks
Stroke volume
Structural cardiac parameter: measured by MRI scan and echocardiography
Measured: 12 weeks
Left ventricular and atrial end-diastolic volume
Structural cardiac parameter: measured by MRI scan and echocardiography
Measured: 12 weeks
LVEF
Functional cardiac parameters: measured by MRI scan and echocardiography
Measured: 12 weeks
Global longitudinal strain
Functional cardiac parameters: measured by MRI scan and echocardiography
Measured: 12 weeks
E/A ratio
Functional cardiac parameters: measured by MRI scan and echocardiography
Measured: 12 weeks
E/é
Functional cardiac parameters: measured by MRI scan and echocardiography
Measured: 12 weeks
Left ventricular and atrial end-systolic volume
Structural cardiac parameter: measured by MRI scan and echocardiography
Measured: 12 weeks
Left atrial volume index
Structural cardiac parameter: measured by MRI scan and echocardiography
Measured: 12 weeks
Interventricular septum thickness
Structural cardiac parameter: measured by MRI scan and echocardiography
Measured: 12 weeks
Left ventricular posterior wall thickness
Structural cardiac parameter: measured by MRI scan and echocardiography
Measured: 12 weeks
Aortic and pulmonary distensibility and pulse wave velocity
Functional vascular parameter: measured by MRI
Measured: 12 weeks
Subcutaneous, visceral and epicardial adipose tissue
Measured by MRI and MR spectroscopy
Measured: 12 weeks
Intramyocardial triglyceride content
Measured by MRI and MR spectroscopy
Measured: 12 weeks
Cardiorespiratory fitness
Measured with an incremental VO2 protocol on exercise bike
Measured: 12 weeks
Dynamic spirometry
Pulmonary function testing
Measured: 12 weeks
Whole body plethysmography
Pulmonary function testing
Measured: 12 weeks
Diffusion capacity
Pulmonary function testing
Measured: 12 weeks
Body composition
Measured by a DXA scan
Measured: 12 weeks
Oral glucose tolerance test
75g of glucose taken while fasting
Measured: 12 weeks
Axial accelerometer-based physical activity monitors
Free-living physical activity is measured using axial accelerometer-based physical activity monitors (AX3; Axivity, Newcastle upon Tyne, UK) for a 5-day period
Measured: 5 days in week 6 of the intervention/control
Dietary intake
Self reported intake of all foods and liquids
Measured: 3 days in the week 6 of intervention/control
Blood sample
Change in fasting total cholesterol, low-density lipoprotein (LDL)-cholesterol and high-density lipoprotein (HDL)-cholesterol (mmol/L). Following an overnight fast (10 hours), blood samples are collected and processed by a trained laboratory technician and analysed according to standard procedures.
Measured: 12 weeks
Blood sample
Change in triglycerides (mmol/L). Following an overnight fast (10 hours), blood samples are collected and processed by a trained laboratory technician and analysed according to standard procedures.
Measured: 12 weeks
RA disease specific outcomes 1
Change in measures of the international Core Outcome Set for rheumatoid arthritis : 66/68 tender and swollen joint count
Measured: 12 weeks
RA disease specific outcomes 2
Change in visual analogue scale (VAS) pain, VAS physician global assessment, VAS patient global assessment
The Visual Analogue Scale (VAS) is a self-report measure consisting simply of a 100 mm horixontal line with a statement at each end representing one extreme (0mm = nothing, 100mm = extreme)
Measured: 12 weeks
RA disease specific outcomes 3
Change in Health Assessment Questionnaire (HAQ-DI)
Total score is between 0-3.0. Increasing scores indicate worse functioning with 0 indicating no functional impairment and 3 indicating complete impairment.
Measured: 12 weeks
RA disease specific outcomes 4
Change in Short Form 36 (SF-36) Health Survey Questionnaire
A 8-scale score within 8 domains.All items are scored so that a high score defines a more favorable health state.
Measured: 12 weeks
RA disease specific outcomes 5
Change in the composite Disease Activity Score-28 ESR for Rheumatoid Arthritis (DAS28).
A DAS28 of greater than 5.1 implies active disease, less than 3.2 low disease activity, and less than 2.6 remission
Measured: 12 weeks
RA disease specific outcomes 6
Change in response criteria will be assessed according the clinical disease activity index (CDAI).
The CDAI composite index quantifies disease activity in RA, by utilising four clinical parameters including tender and swollen joints and global assessment from both patient and assessor on a vasual analogue scale.
CDAI interpretation score CDAI ≥ 22,1: High Activity CDAI < 22,1 og ≥10,1: Moderate Activity CDAI <10,0 og ≥ 2,9: Low Activity CDAI <2,9: Remission
Measured: 12 weeks
RA disease specific outcomes 7
Change in response criteria will be assessed according the American College of Rheumatology (ACR 20/50/70) response
Measured: 12 weeks
RA disease specific outcomes 8
Change in response criteria will be assessed according the European League Against Rheumatism (EULAR none/good/moderate response)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start1 Jan 2021
- Primary completion10 Aug 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Regitse Christensen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Regitse Christensen, Principal investigator, Center for Physical Activity Research, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05215509
- Sponsor's protocol ID
- H-21010559
- Acronym
- RABEX
- Status last verified
- Feb 2024
- First submitted
- 16 Nov 2021
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised IPD obtained through this study may be provided to qualified researchers upon reasonable request.
Publications
Jonck S, Adamsen ML, Rasmussen IE, Lytzen AA, Lok M, Vonsild Lund MA, Dreyer L, Jorgensen PG, Vejlstrup N, Kober L, Christensen R, Jacobsen S, Pedersen BK, Ellingsgaard H, Hojgaard P, Berg RMG, Christensen RH. IL-6 Inhibitors and TNF Inhibitors: Impact on Exercise-induced Cardiac Adaptations in Patients With Rheumatoid Arthritis. JACC Basic Transl Sci. 2025 May;10(5):551-563. doi: 10.1016/j.jacbts.2024.11.010. Epub 2025 Feb 5.
PubMed 40436519Jonck S, Adamsen ML, Hojgaard P, Rasmussen IE, Ellingsgaard H, Lund MAV, Jorgensen PG, Jacobsen S, Kober L, Vejlstrup N, Dreyer L, Pedersen BK, Berg RMG, Christensen RH. Effect of a 12-week high-intensity exercise intervention: a comparison of cardiac exercise adaptations during biological disease-modifying antirheumatic drug treatment (TNF inhibitors vs IL-6 signalling inhibitors) in patients with rheumatoid arthritis - study protocol for a randomised controlled trial. BMJ Open. 2023 May 11;13(5):e068600. doi: 10.1136/bmjopen-2022-068600.
PubMed 37169504
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise-induced Cardiac Adaptions in Rheumatoid Arthritis Patients During Interleukin-6 vs. Tumor Necrosis Factor Antibody Therapy: a Randomised, Controlled Study.
- ClinicalTrials.gov ID
- NCT05215509
- Acronym / sponsor ID
- RABEX / H-21010559
- Conditions
- Rheumatoid Arthritis
- Keywords
- Cardiac adaptations, Metabolic adaptations, High intensity interval training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 31 Jan 2022 (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 present study will investigative the physiological effects of the cytokines interleukin-6 (IL-6) and tumor necrosis factor (TNF) on the adaptive changes to exercise in patients with rheumatoid arthritis. The investigators hypothesize that blockage of IL-6 receptors will decrease the cardiac and metabolic adaptations to exercise training compared to the inhibition of TNF. 80 patients will be included in a 12-week investigator blinded randomised exercise training intervention study.
Detailed description
80 patients with rheumatoid arthritis who are being treated with either interleukin-6 receptor blockers (IL-6Rb) or tumor necrosis factor inhibitors (TNFi) for a minimum of four months prior to enrollment will be recruited and undergo baseline testing, including examination, biochemistry, ECG, DXA, OGTT, pulmonary function, VO2max, echocardiography, cardiac MRI.
After baseline testing, 40 patients in IL-6 receptor blocker treatment and 40 patients in TNF inhibitor treatment.will be randomly allocated into one group receiving standard of care (control group) or a group performing supervised high-intensity interval training three times a week over a period of 12 weeks. The randomization procedure involves a computer-generated block randomization schedule in a ratio of 1:1 stratified by sex by an independent person. Following the 12-week intervention period, all groups will complete a series of follow-up tests (as baseline testing).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| RA patients TNFi Exercise | Experimental | Behavioral: ExerciseThe patients will be randomized to 12-week supervised exercise training intervention or no exercise training. The exercise training program includes three supervised sessions per week over a 12-week period. The program consists of high intensity endurance training on ergometer bicycles. The intensity will progress throughout the 12 weeks of training. The training consists of 10 minutes of warm up at 40-60% maximum heart rate (HRmax), followed by 25 minutes of high intensity interval training (4 bouts of 4 min at >85% HRmax interspaced by 3 minutes of low intensity training at 40-60% Hrmax) and finally a 5 min cool-down of 50% Hrmax |
| RA patients TNFi Control | Active comparator | Behavioral: No exerciseThis group will be allocated to "control" and therefore no supervised exercise regimen |
| RA patients IL-6Rb Exercise | Experimental | Behavioral: ExerciseThe patients will be randomized to 12-week supervised exercise training intervention or no exercise training. The exercise training program includes three supervised sessions per week over a 12-week period. The program consists of high intensity endurance training on ergometer bicycles. The intensity will progress throughout the 12 weeks of training. The training consists of 10 minutes of warm up at 40-60% maximum heart rate (HRmax), followed by 25 minutes of high intensity interval training (4 bouts of 4 min at >85% HRmax interspaced by 3 minutes of low intensity training at 40-60% Hrmax) and finally a 5 min cool-down of 50% Hrmax |
| RA patients IL-6Rb Control | Active comparator | Behavioral: No exerciseThis group will be allocated to "control" and therefore no supervised exercise regimen |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age >= 18 and <70 years
- Informed consent
- Diagnosed RA based on the 2010 American College of Rheumatology/ EULAR criteria. In biological treatment with either IL-6rB og TNFi over four months prior to enrollment
- Low RA disease activity, based on the Disease Activity Score-28 ESR for Rheumatoid Arthritis (DAS28) <=3.2
- An electrocardiogram without features of left ventricular hypertrophy defined by the European Society of Cardiology
Key exclusion criteria (7 listed)
- Health conditions that prevent participating in the exercise intervention determined by the Project Coordinator
- Subjects who cannot undergo MRI scans (metallic implants or claustrophobia)
- Corticosteroid use per os > 10 mg/day within seven days of study enrollment
- Intramuscular corticosteroid within 3 weeks of the study enrollment
- Grade 2 hypertension (systolic BP > 160 mmHg and/or diastolic BP >100 mmHg) despite the use of antihypertensive drugs.
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 |
|---|---|---|
| ExerciseAlso: High intensity interval trainingSupervised high-intensity interval training for 12 weeks three times per week. The supervision may be physical or online supervision | Behavioural | RA patients IL-6Rb Exercise, RA patients TNFi Exercise |
| No exerciseControl group, therefore no supervised exercise regime | Behavioural | RA patients IL-6Rb Control, RA patients TNFi Control |
Primary outcome
Change in left ventricular mass
Time frame: 12 weeks
measured by MRI scan
32 secondary outcomes
Visceral adipose tissue mass
Time frame: 12 weeks
Stroke volume
Time frame: 12 weeks
Left ventricular and atrial end-diastolic volume
Time frame: 12 weeks
LVEF
Time frame: 12 weeks
Global longitudinal strain
Time frame: 12 weeks
E/A ratio
Time frame: 12 weeks
E/é
Time frame: 12 weeks
Left ventricular and atrial end-systolic volume
Time frame: 12 weeks
Left atrial volume index
Time frame: 12 weeks
Interventricular septum thickness
Time frame: 12 weeks
Left ventricular posterior wall thickness
Time frame: 12 weeks
Aortic and pulmonary distensibility and pulse wave velocity
Time frame: 12 weeks
Subcutaneous, visceral and epicardial adipose tissue
Time frame: 12 weeks
Intramyocardial triglyceride content
Time frame: 12 weeks
Cardiorespiratory fitness
Time frame: 12 weeks
Dynamic spirometry
Time frame: 12 weeks
Whole body plethysmography
Time frame: 12 weeks
Diffusion capacity
Time frame: 12 weeks
Body composition
Time frame: 12 weeks
Oral glucose tolerance test
Time frame: 12 weeks
Axial accelerometer-based physical activity monitors
Time frame: 5 days in week 6 of the intervention/control
Dietary intake
Time frame: 3 days in the week 6 of intervention/control
Blood sample
Time frame: 12 weeks
Blood sample
Time frame: 12 weeks
RA disease specific outcomes 1
Time frame: 12 weeks
RA disease specific outcomes 2
Time frame: 12 weeks
RA disease specific outcomes 3
Time frame: 12 weeks
RA disease specific outcomes 4
Time frame: 12 weeks
RA disease specific outcomes 5
Time frame: 12 weeks
RA disease specific outcomes 6
Time frame: 12 weeks
RA disease specific outcomes 7
Time frame: 12 weeks
RA disease specific outcomes 8
Time frame: 12 weeks
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 2 Feb 2024.
- Derived from this study: PubMed 40436519Jonck S, Adamsen ML, Rasmussen IE, Lytzen AA, Lok M, Vonsild Lund MA, Dreyer L, Jorgensen PG, Vejlstrup N, Kober L, Christensen R, Jacobsen S, Pedersen BK, Ellingsgaard H, Hojgaard P, Berg RMG, Christensen RH. IL-6 Inhibitors and TNF Inhibitors: Impact on Exercise-induced Cardiac Adaptations in Patients With Rheumatoid Arthritis. JACC Basic Transl Sci. 2025 May;10(5):551-563. doi: 10.1016/j.jacbts.2024.11.010. Epub 2025 Feb 5.
- Derived from this study: PubMed 37169504Jonck S, Adamsen ML, Hojgaard P, Rasmussen IE, Ellingsgaard H, Lund MAV, Jorgensen PG, Jacobsen S, Kober L, Vejlstrup N, Dreyer L, Pedersen BK, Berg RMG, Christensen RH. Effect of a 12-week high-intensity exercise intervention: a comparison of cardiac exercise adaptations during biological disease-modifying antirheumatic drug treatment (TNF inhibitors vs IL-6 signalling inhibitors) in patients with rheumatoid arthritis - study protocol for a randomised controlled trial. BMJ Open. 2023 May 11;13(5):e068600. doi: 10.1136/bmjopen-2022-068600.
- Individual participant dataSharing planned: Yes. Anonymised IPD obtained through this study may be provided to qualified researchers upon reasonable request.
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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.
Regitse Christensen principal investigator
Center for Physical Activity Research, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and No exercise in people with Rheumatoid Arthritis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 16 inclusion and 7 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 2 Feb 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 Denmark. 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?
Change in left ventricular mass (time frame: 12 weeks). 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 NCT05215509, 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 2 Feb 2024.