Mitral RegurgitationMILLENNIALNCT06075823
Edge-to-edge Mitral Valve Repair in ATTR-CM
A study testing TEER and Optimal Medical Therapy in people with Mitral Regurgitation and ATTR-Cardiomyopathy, run by Medical University of Vienna at 10 sites in 3 countries.
Trial summary
No previous study has evaluated the effectiveness of transcatheter edge-to-edge mitral valve repair (TEER) in patients with ATTR-associated cardiomyopathy (ATTR-CM) and significant mitral regurgitation, as this specific patient population was specifically excluded from previous large TEER trials. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation, ATTR-Cardiomyopathy, Edge-to-Edge Mitral Valve Repair
- What is being tested?
- TEER and Optimal Medical Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 1 Jan 2024to 12 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Proven ATTR-CM
- Significant symptomatic MR (3+ or 4+ by independent echocardiographic core laboratory assessment)
- Subject has been adequately treated per applicable standards, including for coronary artery disease and heart failure (e.g., diuretics)
- New York Heart Association (NYHA) functional class II, III, or ambulatory IV
- Local heart team has determined that mitral valve surgery will not be offered as a treatment option, even if the subject is randomized to the control group
- Left ventricular ejection fraction ≥20%
Show all 9Show fewer
- Anatomical feasibility for TEER as per discretion of the implanting investigator
- Age 18 years or older
- Subject or guardian agrees to all provisions of the protocol, including the possibility of randomization to the Control group and returning for all required post-procedure follow-up visits, and has provided written informed consent
Who cannot join
- AL-associated cardiomyopathy
- Aortic valve disease requiring surgery or transcatheter intervention
- Severe right ventricular dysfunction
- Hemodynamic instability requiring inotropic support or mechanical heart assistance
- Leaflet anatomy which may preclude TEER, proper device positioning on the leaflets or sufficient reduction in mitral regurgitation by TEER
- Life expectancy <12 months due to non-cardiac conditions
Show all 13Show fewer
- Prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation
- Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., noncompliant, perforated)
- Active infections requiring current antibiotic therapy
- Transesophageal echocardiography (TEE) is contraindicated or high risk
- Pregnant or planning pregnancy within next 12 months
- Currently participating in another investigational device study that has not reached its primary endpoint
Trial locations and contacts
10 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 3 countries
Austria5 sites, 5 recruiting
- Recruiting
Medical University of Graz, Division of Cardiology
Graz
Nicolas Verheyen, MD, nicolas.verheyen@medunigraz.at
- Recruiting
Ordensklinikum Linz Elisabethinen, Internal Medicine 2, Cardiology
Linz
Christian Ebner, MD, Christian.Ebner@ordensklinikum.at
- Recruiting
University Hospital St. Pölten, Department of Internal Medicine 3
Sankt Pölten
Julia Mascherbauer, MD, Julia.Mascherbauer@stpoelten.lknoe.at
- Recruiting
Clinic Favoriten, 5th Medical Department, Cardiology
Vienna, 1090
Diana Bonderman, MD, diana.bonderman@gesundheitsverbund.at
- Recruiting
Medical University of Vienna
Vienna, 1090
Christian Nitsche, MD, PhD, 01 40400 46142, christian.nitsche@meduniwien.ac.at
Germany3 sites, 3 recruiting
- Not yet recruiting
Hannover Medical School, Department of Cardiology and Angiology
Hanover
Dominik Berliner, MD, berliner.dominik@mh-hannover.de
- Recruiting
University Hospital Heidelberg, Department of Cardiology, Angiology and Respiratory Medicine
Heidelberg
Mathias Konstandin, MD, Mathias.Konstandin@med.uni-heidelberg.de
- Recruiting
LMU University Hospital, Department of Medicine I
München
Jörg Hausleiter, MD, Joerg.Hausleiter@med.uni-muenchen.de
Italy2 sites, 2 recruiting
- Not yet recruiting
ASST Papa Giovanni XXIII, Cardiovascular Department
Bergamo
Edoardo Sciatti, MD, esciatti@asst-pg23.it
- Recruiting
ASST Spedali Civili di Brescia, Cardiology
Brescia
Marianna Adamo, MD, mariannaadamo@hotmail.com
About this study
Official title: Effectiveness and Safety of Edge-to-edge MItral vaLve Repair in Patients With Significant mitraL rEgurgitatioN aNd cardIac ATTR amyLoidosis
No previous study has evaluated the effectiveness of transcatheter edge-to-edge mitral valve repair (TEER) in patients with ATTR-associated cardiomyopathy (ATTR-CM) and significant mitral regurgitation, as this specific patient population was specifically excluded from previous large TEER trials. From a pathophysiological perspective, effective treatment of significant regurgitant volume and consecutive improvement of forward volume appears highly desirable in a condition with intrinsically low output. However, whether this translates into improved functional capacity, better quality of life, and better clinical outcomes compared to conservative heart failure management alone remains to be investigated.
Read the detailed description
MILLENNIAL is an investigator-initiated, multicentre, prospective, parallel-group, open-label, randomized controlled trial. Patients with proven ATTR-CM and concomitant significant (moderate-to-severe or severe) symptomatic mitral regurgitation, in whom the local heart team has ruled out mitral valve surgery and who are anatomically suitable for TEER, are randomized 1:1 to TEER plus optimal medical therapy (OMT) or OMT alone. Randomization is performed centrally with permuted blocks of variable size (4-8), stratified by the presence of significant tricuspid regurgitation and NYHA class ≥III. ATTR-specific therapy is allowed in both arms at the discretion of the treating physician. Cross-over is not permitted within the first year.
The primary endpoint is a hierarchical composite assessed at 12 months, analysed with the Finkelstein-Schoenfeld method (win ratio as effect measure, stratified by National Amyloidosis Centre stage): (1) all-cause mortality, (2) cumulative frequency of unplanned cardiovascular hospitalizations, (3) change from baseline in 6-minute walk distance (win threshold ≥30 m), (4) change from baseline in KCCQ Overall Summary score (win threshold ≥5 points). Heart transplantation, combined heart-liver transplantation and durable mechanical circulatory support are counted as death. Change in NT-proBNP is the key secondary endpoint; technical, device and procedural success (MVARC) are safety endpoints. Exploratory endpoints include intraprocedural invasive haemodynamics before and after device deployment and advanced echocardiographic indices of myocardial performance.
A sample size of 106 patients (53 per arm) provides 80% power at a two-sided alpha of 0.05 for an assumed win ratio of 2.1, including 10% cross-over and 5% drop-out. Study visits take place at baseline, 6 months (±7 days) and 12 months (±14 days). Interim analyses are performed after every 25 patients and reviewed by an independent data monitoring committee; a pre-specified futility analysis is performed once 50 patients have completed 12-month follow-up (stop if conditional power <10%).
- Being tested
- TEER, Optimal Medical Therapy
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEERDevice
Transcatheter edge-to-edge mitral valve repair under general anaesthesia with transoesophageal echocardiographic and fluoroscopic guidance; up to three newer-generation MitraClip (NTR, XTR; Abbott) or PASCAL (Edwards Lifesciences) devices to maximally reduce mitral regurgitation. Intraprocedural invasive haemodynamic measurements before and after device deployment.
Optimal Medical TherapyOther
Optimal medical therapy according to the current understanding of heart failure management in ATTR-CM (careful volume management, rate/rhythm control in atrial fibrillation, anticoagulation where indicated). ATTR-specific therapy (e.g. tafamidis, acoramidis) is allowed but not mandatory in both arms at the discretion of the treating physician; all heart failure and ATTR-specific medication is recorded at every visit.
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | TEER + Optimal Medical Therapy Receives: Device: TEER; Other: Optimal Medical Therapy |
| Control | Active comparator | Optimal Medical Therapy alone Receives: Other: Optimal Medical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hierarchical composite of all-cause mortality, cumulative frequency of unplanned cardiovascular-related hospitalizations, change from baseline in 6-minute walk distance, and change from baseline in KCCQ Overall Summary score through month 12
Each subject in the TEER+OMT group is compared with each subject in the OMT group in a pairwise manner, within strata defined by National Amyloidosis Centre disease stage (I, II, III) at baseline, in hierarchical order: (1) all-cause mortality (heart transplantation, combined heart-liver transplantation and implantation of a durable mechanical cardiac-assist device count as death); (2) cumulative frequency of unplanned cardiovascular-related hospitalizations, compared over the shorter follow-up time of the pair; (3) change from baseline in 6-minute walk distance, a difference of ≥30 m defining a win (smaller differences are ties); (4) change from baseline in the Kansas City Cardiomyopathy Questionnaire Overall Summary score (0-100, higher = better health status), a difference of ≥5 points defining a win. Statistical significance is tested with the Finkelstein-Schoenfeld method at a two-sided alpha of 0.05; the win ratio quantifies the treatment effect.
Measured: 12 months
Secondary outcomes (2)
Change from baseline in NT-proBNP (key secondary endpoint)
Change from baseline in N-terminal pro-B-type natriuretic peptide (pg/mL), analysed with a mixed-effects model for repeated measures / analysis of covariance with treatment group and visit as fixed effects and the baseline value as covariate.
Measured: Baseline, 6 months and 12 months
Technical, device, and procedural success of TEER (in the TEER group only)
Technical, device, and procedural success of TEER as defined according to the definitions of the Mitral Valve Academic Research Consortium (MVARC)
Measured: Technical success at exit from the procedure room; device and procedural success at 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Jan 2024
- Primary completion12 Dec 2027 (estimated)
- Study completion12 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mitral RegurgitationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Austrian Science Fund (FWF)
- Responsible party
- Principal investigator, Christian Nitsche, Medical University of Vienna
- Investigators
- Christian Nitsche, MD, PhD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06075823
- Sponsor's protocol ID
- 1830/2023
- Acronym
- MILLENNIAL
- Status last verified
- Oct 2026
- First submitted
- 27 Sep 2023
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stone GW, Lindenfeld J, Abraham WT, Kar S, Lim DS, Mishell JM, Whisenant B, Grayburn PA, Rinaldi M, Kapadia SR, Rajagopal V, Sarembock IJ, Brieke A, Marx SO, Cohen DJ, Weissman NJ, Mack MJ; COAPT Investigators. Transcatheter Mitral-Valve Repair in Patients with Heart Failure. N Engl J Med. 2018 Dec 13;379(24):2307-2318. doi: 10.1056/NEJMoa1806640. Epub 2018 Sep 23.
PubMed 30280640Dona C, Nitsche C, Koschutnik M, Heitzinger G, Mascherbauer K, Kammerlander AA, Dannenberg V, Halavina K, Rettl R, Duca F, Traub-Weidinger T, Puchinger J, Gunacker PC, Lamm G, Vock P, Lileg B, Philipp V, Staudenherz A, Calabretta R, Hacker M, Agis H, Bartko P, Hengstenberg C, Fontana M, Goliasch G, Mascherbauer J. Unveiling Cardiac Amyloidosis, its Characteristics, and Outcomes Among Patients With MR Undergoing Transcatheter Edge-to-Edge MV Repair. JACC Cardiovasc Interv. 2022 Sep 12;15(17):1748-1758. doi: 10.1016/j.jcin.2022.06.009. Epub 2022 Aug 22.
PubMed 36008266Chacko L, Karia N, Venneri L, Bandera F, Passo BD, Buonamici L, Lazari J, Ioannou A, Porcari A, Patel R, Razvi Y, Brown J, Knight D, Martinez-Naharro A, Whelan C, Quarta CC, Manisty C, Moon J, Rowczenio D, Gilbertson JA, Lachmann H, Wechelakar A, Petrie A, Moody WE, Steeds RP, Potena L, Riefolo M, Leone O, Rapezzi C, Hawkins PN, Gillmore JD, Fontana M. Progression of echocardiographic parameters and prognosis in transthyretin cardiac amyloidosis. Eur J Heart Fail. 2022 Sep;24(9):1700-1712. doi: 10.1002/ejhf.2606. Epub 2022 Jul 27.
PubMed 35779241Nitsche C. Echocardiographic tracking of transthyretin cardiomyopathy: which parameters matter the most? Eur J Heart Fail. 2022 Sep;24(9):1713-1715. doi: 10.1002/ejhf.2639. Epub 2022 Aug 12. No abstract available.
PubMed 35906799
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Edge-to-edge MItral vaLve Repair in Patients With Significant mitraL rEgurgitatioN aNd cardIac ATTR amyLoidosis
- ClinicalTrials.gov ID
- NCT06075823
- Acronym / sponsor ID
- MILLENNIAL / 1830/2023
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Austrian Science Fund (FWF)
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 12 Dec 2027 (estimated)
- Study completion
- 12 Dec 2028 (estimated)
- First posted
- 10 Oct 2023 (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.
No previous study has evaluated the effectiveness of transcatheter edge-to-edge mitral valve repair (TEER) in patients with ATTR-associated cardiomyopathy (ATTR-CM) and significant mitral regurgitation, as this specific patient population was specifically excluded from previous large TEER trials. From a pathophysiological perspective, effective treatment of significant regurgitant volume and consecutive improvement of forward volume appears highly desirable in a condition with intrinsically low output. However, whether this translates into improved functional capacity, better quality of life, and better clinical outcomes compared to conservative heart failure management alone remains to be investigated.
Detailed description
MILLENNIAL is an investigator-initiated, multicentre, prospective, parallel-group, open-label, randomized controlled trial. Patients with proven ATTR-CM and concomitant significant (moderate-to-severe or severe) symptomatic mitral regurgitation, in whom the local heart team has ruled out mitral valve surgery and who are anatomically suitable for TEER, are randomized 1:1 to TEER plus optimal medical therapy (OMT) or OMT alone. Randomization is performed centrally with permuted blocks of variable size (4-8), stratified by the presence of significant tricuspid regurgitation and NYHA class ≥III. ATTR-specific therapy is allowed in both arms at the discretion of the treating physician. Cross-over is not permitted within the first year.
The primary endpoint is a hierarchical composite assessed at 12 months, analysed with the Finkelstein-Schoenfeld method (win ratio as effect measure, stratified by National Amyloidosis Centre stage): (1) all-cause mortality, (2) cumulative frequency of unplanned cardiovascular hospitalizations, (3) change from baseline in 6-minute walk distance (win threshold ≥30 m), (4) change from baseline in KCCQ Overall Summary score (win threshold ≥5 points). Heart transplantation, combined heart-liver transplantation and durable mechanical circulatory support are counted as death. Change in NT-proBNP is the key secondary endpoint; technical, device and procedural success (MVARC) are safety endpoints. Exploratory endpoints include intraprocedural invasive haemodynamics before and after device deployment and advanced echocardiographic indices of myocardial performance.
A sample size of 106 patients (53 per arm) provides 80% power at a two-sided alpha of 0.05 for an assumed win ratio of 2.1, including 10% cross-over and 5% drop-out. Study visits take place at baseline, 6 months (±7 days) and 12 months (±14 days). Interim analyses are performed after every 25 patients and reviewed by an independent data monitoring committee; a pre-specified futility analysis is performed once 50 patients have completed 12-month follow-up (stop if conditional power <10%).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Device: TEER, Other: Optimal Medical TherapyTEER + Optimal Medical Therapy |
| Control | Active comparator | Other: Optimal Medical TherapyOptimal Medical Therapy alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Proven ATTR-CM
- Significant symptomatic MR (3+ or 4+ by independent echocardiographic core laboratory assessment)
- Subject has been adequately treated per applicable standards, including for coronary artery disease and heart failure (e.g., diuretics)
- New York Heart Association (NYHA) functional class II, III, or ambulatory IV
- Local heart team has determined that mitral valve surgery will not be offered as a treatment option, even if the subject is randomized to the control group
Key exclusion criteria (13 listed)
- AL-associated cardiomyopathy
- Aortic valve disease requiring surgery or transcatheter intervention
- Severe right ventricular dysfunction
- Hemodynamic instability requiring inotropic support or mechanical heart assistance
- Leaflet anatomy which may preclude TEER, proper device positioning on the leaflets or sufficient reduction in mitral regurgitation by TEER
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 |
|---|---|---|
| TEERTranscatheter edge-to-edge mitral valve repair under general anaesthesia with transoesophageal echocardiographic and fluoroscopic guidance; up to three newer-generation MitraClip (NTR, XTR; Abbott) or PASCAL (Edwards Lifesciences) devices to maximally reduce mitral regurgitation. Intraprocedural invasive haemodynamic measurements before and after device deployment. | Device | Interventional |
| Optimal Medical TherapyOptimal medical therapy according to the current understanding of heart failure management in ATTR-CM (careful volume management, rate/rhythm control in atrial fibrillation, anticoagulation where indicated). ATTR-specific therapy (e.g. tafamidis, acoramidis) is allowed but not mandatory in both arms at the discretion of the treating physician; all heart failure and ATTR-specific medication is recorded at every visit. | Other | Control, Interventional |
Primary outcome
Hierarchical composite of all-cause mortality, cumulative frequency of unplanned cardiovascular-related hospitalizations, change from baseline in 6-minute walk distance, and change from baseline in KCCQ Overall Summary score through month 12
Time frame: 12 months
Each subject in the TEER+OMT group is compared with each subject in the OMT group in a pairwise manner, within strata defined by National Amyloidosis Centre disease stage (I, II, III) at baseline, in hierarchical order: (1) all-cause mortality (heart transplantation, combined heart-liver transplantation and implantation of a durable mechanical cardiac-assist device count as death); (2) cumulative frequency of unplanned cardiovascular-related hospitalizations, compared over the shorter follow-up time of the pair; (3) change from baseline in 6-minute walk distance, a difference of ≥30 m defining a win (smaller differences are ties); (4) change from baseline in the Kansas City Cardiomyopathy Questionnaire Overall Summary score (0-100, higher = better health status), a difference of ≥5 points defining a win. Statistical significance is tested with the Finkelstein-Schoenfeld method at a two-sided alpha of 0.05; the win ratio quantifies the treatment effect.
2 secondary outcomes
Change from baseline in NT-proBNP (key secondary endpoint)
Time frame: Baseline, 6 months and 12 months
Technical, device, and procedural success of TEER (in the TEER group only)
Time frame: Technical success at exit from the procedure room; device and procedural success at 6 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Background: PubMed 30280640Stone GW, Lindenfeld J, Abraham WT, Kar S, Lim DS, Mishell JM, Whisenant B, Grayburn PA, Rinaldi M, Kapadia SR, Rajagopal V, Sarembock IJ, Brieke A, Marx SO, Cohen DJ, Weissman NJ, Mack MJ; COAPT Investigators. Transcatheter Mitral-Valve Repair in Patients with Heart Failure. N Engl J Med. 2018 Dec 13;379(24):2307-2318. doi: 10.1056/NEJMoa1806640. Epub 2018 Sep 23.
- Results publication: PubMed 36008266Dona C, Nitsche C, Koschutnik M, Heitzinger G, Mascherbauer K, Kammerlander AA, Dannenberg V, Halavina K, Rettl R, Duca F, Traub-Weidinger T, Puchinger J, Gunacker PC, Lamm G, Vock P, Lileg B, Philipp V, Staudenherz A, Calabretta R, Hacker M, Agis H, Bartko P, Hengstenberg C, Fontana M, Goliasch G, Mascherbauer J. Unveiling Cardiac Amyloidosis, its Characteristics, and Outcomes Among Patients With MR Undergoing Transcatheter Edge-to-Edge MV Repair. JACC Cardiovasc Interv. 2022 Sep 12;15(17):1748-1758. doi: 10.1016/j.jcin.2022.06.009. Epub 2022 Aug 22.
- Results publication: PubMed 35779241Chacko L, Karia N, Venneri L, Bandera F, Passo BD, Buonamici L, Lazari J, Ioannou A, Porcari A, Patel R, Razvi Y, Brown J, Knight D, Martinez-Naharro A, Whelan C, Quarta CC, Manisty C, Moon J, Rowczenio D, Gilbertson JA, Lachmann H, Wechelakar A, Petrie A, Moody WE, Steeds RP, Potena L, Riefolo M, Leone O, Rapezzi C, Hawkins PN, Gillmore JD, Fontana M. Progression of echocardiographic parameters and prognosis in transthyretin cardiac amyloidosis. Eur J Heart Fail. 2022 Sep;24(9):1700-1712. doi: 10.1002/ejhf.2606. Epub 2022 Jul 27.
- Results publication: PubMed 35906799Nitsche C. Echocardiographic tracking of transthyretin cardiomyopathy: which parameters matter the most? Eur J Heart Fail. 2022 Sep;24(9):1713-1715. doi: 10.1002/ejhf.2639. Epub 2022 Aug 12. No abstract available.
- 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.
Christian Nitsche, MD, PhD principal investigator
Medical University of Vienna
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEER and Optimal Medical Therapy in people with Mitral Regurgitation and ATTR-Cardiomyopathy, run by Medical University of Vienna at 10 sites in 3 countries.
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 9 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Austria, Germany, Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christian Nitsche, MD, PhD (0043 1 40400 46142, christian.nitsche@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hierarchical composite of all-cause mortality, cumulative frequency of unplanned cardiovascular-related hospitalizations, change from baseline in 6-minute walk distance, and change from baseline in KCCQ Overall Summary score through month 12 (time frame: 12 months). 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 NCT06075823, which also lists 4 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 16 Oct 2026.