Non-ischemic Dilated CardiomyopathyPhase 2DCMIINCT04476901

Administration of Allogeneic-MSC in Patients With Non-Ischemic Dilated Cardiomyopathy

A Phase 2 study testing allogeneic human mesenchymal stem cells (hMSCs) in people with Non-ischemic Dilated Cardiomyopathy, run by Joshua M Hare at 4 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

The purpose of this study is to evaluate the safety and effectiveness of an experimental drug called human allogeneic mesenchymal stem cell therapy. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Non-ischemic Dilated Cardiomyopathy
What is being tested?: allogeneic human mesenchymal stem cells (hMSCs)
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 107 participants
Where: 4 sitesUnited States
Study dates: 7 May 2021to Apr 2027
Phase: Phase 2
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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Men and women aged 18 to 80 years (inclusive) at the time of signing the informed consent form.
Diagnosis of NIDCM with left ventricular ejection fraction ≤45%.
Appropriate guideline-directed optimal medical therapy for non-ischemic cardiomyopathy. At a minimum, subjects must be on beta blockers and angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) or Angiotensin Receptor Neprilysin Inhibitors (ARNI) or have appropriate medical indication precluding use of one or both of these agents. Subjects must be on a stable regimen for at least 30 days prior to the procedure. Dose titration is allowed.
Be a candidate for cardiac catheterization*
Be willing to undergo DNA test.

Who cannot join

An individual who meets any of the following criteria will be excluded from participation in this study:
Be eligible for or require standard-of-care surgical or percutaneous intervention for the treatment of non-ischemic dilated cardiomyopathy
Clinical manifestation of coronary artery disease (CAD) (e.g., chest pain and concomitant clinical findings such as electrocardiogram changes suggestive of coronary ischemia, myocardial infarction) or evidence of endocardial or transmural scar on cardiac MRI suggestive of undiagnosed CAD or history of percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG). Be indicated for or require coronary artery revascularization
Documented presence of epicardial stenosis of 70% or greater in one or more major epicardial coronary arteries
Valvular heart disease including 1) aortic valve prosthesis, mechanical mitral valve, and mitral valve clip; 2) severe aortic valve insufficiency/regurgitation within 12 months of consent*
Aortic stenosis with valve area ≤ 1.5cm2*

Show all 40Show fewer

Cardiomyopathy due to acute Post-partum (within 6 months), Non-compaction*, or Hypertrophic* cardiomyopathy
Cardiomyopathy due to known toxin (e.g amyloid) Note: anthracycline induced cardiomyopathy will be allowed
QTc interval > 550 ms on baseline electrocardiogram (ECG) (note: QTc interval is the interval between the start of the Q wave and the end of the T wave in the heart's electrical cycle)
Automated Implantable Cardioverter Defibrillator (AICD) appropriate firing or anti tachycardia pacing for ventricular tachycardia or ventricular fibrillation within 30 days prior to consent
Have an estimated baseline glomerular filtration rate below the clinical site's institutional cutoff
A hematologic abnormality during baseline testing as evidenced by hemoglobin < 9 g/dl; hematocrit < 30%; absolute neutrophil count < 2,000 or total WBC count more than 2 times upper limit of normal; or platelet values < 100,000/ul
Have liver dysfunction, as evidenced by enzymes Aspartate Transaminase Enzyme (AST) and Alanine Aminotransferase Enzyme (ALT) greater than three times the ULN
Have a bleeding diathesis or coagulopathy (International Normalised Ratio (INR) > 1.5), cannot be withdrawn from anticoagulation therapy, or will refuse blood transfusions
Be a solid organ transplant recipient. This does not include prior cell based therapy (>12 months prior to enrollment), bone, skin, ligament, tendon or corneal grafting.
Have a history of organ or cell transplant rejection
Have a clinical history of malignancy within the past 12 months (i.e., subjects with prior malignancy must be disease free for 12 months), except curatively treated basal cell or squamous cell carcinoma or cervical carcinoma
Drug and/or alcohol abuse or dependence within the past 9 months
Be serum positive for HIV, hepatitis B surface antigen, or viremic hepatitis C
Documented presence of a known Left Ventricular (LV) thrombus, aortic dissection, or aortic aneurysm. (Refer to "Guidance to the PI" section with regards to LV thrombus, below)*
Blood glucose levels (HbA1c) >10%
Severe radiographic contrast allergy
Known history of anaphylactic reaction to penicillin or streptomycin
Hypersensitivity to dimethyl sulfoxide (DMSO)
Non-cardiac condition with life expectancy < 1 year
Acute stroke or transient ischemic attack within 3 months of enrollment
Be pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods
Pacemaker-dependence with an Implantable Cardioverter Defibrillator (ICD) (Note: pacemaker-dependent candidates without an ICD are not excluded)
Presence of a pacemaker and/or ICD generator with any of the following limitations/conditions:
manufactured before the year 2000
leads implanted < 6 weeks prior to consent
non-transvenous epicardial or abandoned leads
subcutaneous ICDs
leadless pacemakers
A cardiac resynchronization therapy (CRT) device implanted less than 3 months prior to consent
Other MRI contraindications (e.g. subject body habitus incompatible with MRI)
Need for advanced heart failure therapy (e.g. IV inotropes)
Be currently participating (or participated within the previous 30 days) in an investigational therapeutic or device trial
Any other condition that in the judgment of the Investigator would be a contraindication to enrollment or follow-up
() Applies to subjects receiving product via transendocardial administration only

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Texas Heart Institute
Houston, Texas, 77030
University of Louisville
Louisville, Kentucky, 40202
University of Miami Miller School of Medicine
Miami, Florida, 33136
Stanford University
Stanford, California, 94304

Other trials in United States

About this study

Official title: A Phase IIB Randomized, Placebo-Controlled, Multicenter Study of the Comparative Efficacy and Safety of Administration of Allogeneic-MSC Versus Placebo in Patients With Non- Ischemic Dilated Cardiomyopathy

The purpose of this study is to evaluate the safety and effectiveness of an experimental drug called human allogeneic mesenchymal stem cell therapy.

Conditions: Non-ischemic Dilated Cardiomyopathy
Being tested: allogeneic human mesenchymal stem cells (hMSCs), Placebo
Keywords: Allogeneic mesenchymal stem cells, Bone marrow-derived mesenchymal stem cells

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

allogeneic human mesenchymal stem cells (hMSCs)Biological
allo-hMSCs, 16-20 million cells/ml delivered at a dose of 0.5 ml/ injection x 10 injections for a total of 80-100 million allo-hMSCs or a single administration of intravenous allogeneic hMSCs (100 million).
PlaceboOther
Placebo will be administered as injections of plasmalyte A supplemented with 1% of 25% human serum albumin (HSA). 0.5 ml/ injection x 10 injections or an intravenous placebo infusion of Cell-free PlasmaLyte-A medium supplemented with 1% of 25% human serum albumin (HSA)

Study groups in NCT04476901
Study group	Role	What they receive
Genotype A administered with placebo Group	Placebo comparator	Participants whose blood genotyping resulted with Genotype A (absence of any variant/ presence of benign variant) and randomized to the placebo group will receive the placebo intervention. Receives: Other: Placebo
Genotype A administered with hMSC Group	Experimental	Participants whose blood genotyping resulted with Genotype A (absence of any variant/ presence of benign variant) and randomized to the treatment group will receive the hMSC intervention. Receives: Biological: allogeneic human mesenchymal stem cells (hMSCs)
Genotype B administered with placebo Group	Placebo comparator	Participants whose blood genotyping resulted with Genotype B (variants of uncertain significance) and randomized to the placebo group will receive the placebo intervention. Receives: Other: Placebo
Genotype B administered with hMSC Group	Experimental	Participants whose blood genotyping resulted with Genotype B (variants of uncertain significance) and randomized to the treatment group will receive the hMSC intervention. Receives: Biological: allogeneic human mesenchymal stem cells (hMSCs)
Genotype C administered with placebo Group	Placebo comparator	Participants whose blood genotyping resulted with Genotype C (pathogenic or likely pathogenic variants) and randomized to the placebo group will receive the placebo intervention. Receives: Other: Placebo
Genotype C administered with hMSC Group	Experimental	Participants whose blood genotyping resulted with Genotype C (pathogenic or likely pathogenic variants) and randomized to the treatment group will receive the hMSC intervention. Receives: Biological: allogeneic human mesenchymal stem cells (hMSCs)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in LVEF
Change in Left Ventricular Ejection Fraction (LVEF) as assessed via cardiac Magnetic Resonance Imaging (MRI)
Measured: Baseline, 12 months

Secondary outcomes (14)

Change in global ventricular strain
Change in global ventricular strain as assessed via cardiac Harmonic Phase (HARP) MRI
Measured: Baseline, 12 months
Change in left regional strain
Change in regional ventricular strain as assessed via cardiac HARP MRI
Measured: Baseline, 12 months
Left ventricular function concordance
The left ventricular function concordance will be measured as the Number of individuals who experienced an increase in left ventricular ejection fraction (LVEF) and a simultaneous decrease in both left ventricular end systolic volume index (LVESVI) and left ventricular end diastolic volume index (LVEDVI)
Measured: 12 months
Change in LVEDVI
Change in left ventricular end diastolic index (LVEDVI) as assessed via cardiac MRI
Measured: Baseline, 12 months
Change in LVESVI
Change in left ventricular end systolic index (LVESVI) as assessed via cardiac MRI
Measured: Baseline, 12 months
Change in Maximal oxygen consumption (peak VO2)
Change in maximal oxygen consumption (peak VO2) as assessed via treadmill
Measured: Baseline, 12 months
Change in Exercise tolerance
Change in exercise tolerance as assessed as the distance covered via the six-minute walk test
Measured: Baseline, 12 months
Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) Score
Minnesota Living with Heart Failure Questionnaire (MLHFQ) is a 21-item questionnaire with a total score ranging from 0 to 105 with lower scores indicative of better outcome.
Measured: Baseline, 12 months
Change in New York Heart Association (NYHA) Class
NYHA Classifications of heart failure are as follows: Class I (no limitations); Class II (mild symptoms); Class III (marked limitations); Class IV (Severe limitations)
Measured: Baseline, 12 months
Percent change in flow mediated diameter
Change in endothelial function will be reported as the percent change in flow mediated diameter assessed via flow mediated dilation (FMD).
Measured: Baseline, 12 months
Change in EPC-CFU
Change in endothelial function will be reported as the change in Endothelial Progenitor Cell Colony Forming Unit (EPC-CFU) assessed via blood sample assay
Measured: Baseline, 12 months
Change in N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP)
Change in NT-proBNP as assessed via blood draw
Measured: Baseline, 12 months
Incidence of MACE
Safety will be reported as the incidence of Major Adverse Cardiac Events (MACE) assessed by treating physician
Measured: 12 months
Incidence of TE-SAEs
Safety will be reported as the incidence of Treatment Emergent Serious Adverse Events (TE-SAEs) assessed by treating physician
Measured: Day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 May 2021Apr 2027

First posted20 Jul 2020
Study start7 May 2021
Primary completionApr 2027 (estimated)
Study completionApr 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Non-ischemic Dilated CardiomyopathyStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 107 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04476901
Sponsor's protocol ID: 20200566
Other IDs: CDMRP-PR191597, 20-02-134
Acronym: DCMII
Status last verified: Sep 2026
First submitted: 15 Jul 2020
Last updated: 29 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Performance of the Cardiac Microcurrent (C-MIC) System With a Less Invasively Placed Left Ventricular Lead
Idiopathic Cardiomyopathy, Left Ventricular (LV) Systolic Dysfunction
Active, not recruitingPhase 1
Treatment of Non-ischemic Cardiomyopathies by Intravenous Extracellular Vesicles of Cardiovascular Progenitor Cells
Heart Failure With Reduced Ejection Fraction
Recruiting
High Fat Diet for Cardiac Metabolic Reprogramming
Non-ischemic Dilated Cardiomyopathy, Heart Failure With Reduced Ejection Fraction
Enrolling by invitation
Mainstreaming Genetic Testing for Non-Ischemic Cardiomyopathy in Western Canada
Nonischemic Cardiomyopathy, Dilated Cardiomyopathy (DCM)
Not yet recruiting
Dilated Cardiomyopathy - Unknown Therapeutic Risk Reduction by Contempary Medication and Implantable Cardioverter-Defibrillators (DUTCH-ICD)
Sudden Cardiac Death

All Non-ischemic Dilated Cardiomyopathy trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIB Randomized, Placebo-Controlled, Multicenter Study of the Comparative Efficacy and Safety of Administration of Allogeneic-MSC Versus Placebo in Patients With Non- Ischemic Dilated Cardiomyopathy
ClinicalTrials.gov ID: NCT04476901
Acronym / sponsor ID: DCMII / 20200566
Conditions: Non-ischemic Dilated Cardiomyopathy
Keywords: Allogeneic mesenchymal stem cells, Bone marrow-derived mesenchymal stem cells
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 107 participants (actual)
Lead sponsor: Joshua M HareUniversity, hospital or other
Collaborators: United States Department of Defense, The University of Texas Health Science Center, Houston
Study start: 7 May 2021 (actual)
Primary completion: Apr 2027 (estimated)
Study completion: Apr 2027 (estimated)
First posted: 20 Jul 2020 (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 purpose of this study is to evaluate the safety and effectiveness of an experimental drug called human allogeneic mesenchymal stem cell therapy.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Genotype A administered with placebo Group	Placebo comparator	Other: PlaceboParticipants whose blood genotyping resulted with Genotype A (absence of any variant/ presence of benign variant) and randomized to the placebo group will receive the placebo intervention.
Genotype A administered with hMSC Group	Experimental	Biological: allogeneic human mesenchymal stem cells (hMSCs)Participants whose blood genotyping resulted with Genotype A (absence of any variant/ presence of benign variant) and randomized to the treatment group will receive the hMSC intervention.
Genotype B administered with placebo Group	Placebo comparator	Other: PlaceboParticipants whose blood genotyping resulted with Genotype B (variants of uncertain significance) and randomized to the placebo group will receive the placebo intervention.
Genotype B administered with hMSC Group	Experimental	Biological: allogeneic human mesenchymal stem cells (hMSCs)Participants whose blood genotyping resulted with Genotype B (variants of uncertain significance) and randomized to the treatment group will receive the hMSC intervention.
Genotype C administered with placebo Group	Placebo comparator	Other: PlaceboParticipants whose blood genotyping resulted with Genotype C (pathogenic or likely pathogenic variants) and randomized to the placebo group will receive the placebo intervention.
Genotype C administered with hMSC Group	Experimental	Biological: allogeneic human mesenchymal stem cells (hMSCs)Participants whose blood genotyping resulted with Genotype C (pathogenic or likely pathogenic variants) and randomized to the treatment group will receive the hMSC intervention.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Men and women aged 18 to 80 years (inclusive) at the time of signing the informed consent form.
Diagnosis of NIDCM with left ventricular ejection fraction ≤45%.
Appropriate guideline-directed optimal medical therapy for non-ischemic cardiomyopathy. At a minimum, subjects must be on beta blockers and angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) or Angiotensin Receptor Neprilysin Inhibitors (ARNI) or have appropriate medical indication precluding use of one or both of these agents. Subjects must be on a stable regimen for at least 30 days prior to the procedure. Dose titration is allowed.
Be a candidate for cardiac catheterization*

Key exclusion criteria (40 listed)

An individual who meets any of the following criteria will be excluded from participation in this study:
Be eligible for or require standard-of-care surgical or percutaneous intervention for the treatment of non-ischemic dilated cardiomyopathy
Clinical manifestation of coronary artery disease (CAD) (e.g., chest pain and concomitant clinical findings such as electrocardiogram changes suggestive of coronary ischemia, myocardial infarction) or evidence of endocardial or transmural scar on cardiac MRI suggestive of undiagnosed CAD or history of percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG). Be indicated for or require coronary artery revascularization
Documented presence of epicardial stenosis of 70% or greater in one or more major epicardial coronary arteries
Valvular heart disease including 1) aortic valve prosthesis, mechanical mitral valve, and mitral valve clip; 2) severe aortic valve insufficiency/regurgitation within 12 months of consent*

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
allogeneic human mesenchymal stem cells (hMSCs)allo-hMSCs, 16-20 million cells/ml delivered at a dose of 0.5 ml/ injection x 10 injections for a total of 80-100 million allo-hMSCs or a single administration of intravenous allogeneic hMSCs (100 million).	Biological	Genotype A administered with hMSC Group, Genotype B administered with hMSC Group, Genotype C administered with hMSC Group
PlaceboPlacebo will be administered as injections of plasmalyte A supplemented with 1% of 25% human serum albumin (HSA). 0.5 ml/ injection x 10 injections or an intravenous placebo infusion of Cell-free PlasmaLyte-A medium supplemented with 1% of 25% human serum albumin (HSA)	Other	Genotype A administered with placebo Group, Genotype B administered with placebo Group, Genotype C administered with placebo Group

Primary outcome

Change in LVEF
Time frame: Baseline, 12 months
Change in Left Ventricular Ejection Fraction (LVEF) as assessed via cardiac Magnetic Resonance Imaging (MRI)

14 secondary outcomes

Change in global ventricular strain
Time frame: Baseline, 12 months
Change in left regional strain
Time frame: Baseline, 12 months
Left ventricular function concordance
Time frame: 12 months
Change in LVEDVI
Time frame: Baseline, 12 months
Change in LVESVI
Time frame: Baseline, 12 months
Change in Maximal oxygen consumption (peak VO2)
Time frame: Baseline, 12 months
Change in Exercise tolerance
Time frame: Baseline, 12 months
Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) Score
Time frame: Baseline, 12 months
Change in New York Heart Association (NYHA) Class
Time frame: Baseline, 12 months
Percent change in flow mediated diameter
Time frame: Baseline, 12 months
Change in EPC-CFU
Time frame: Baseline, 12 months
Change in N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP)
Time frame: Baseline, 12 months
Incidence of MACE
Time frame: 12 months
Incidence of TE-SAEs
Time frame: Day 30

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 29 Sep 2026.
Cardiovascular Cell Therapy Research NetworkLink provided by the sponsor.
Information on stem cells from the National Institutes of HealthLink provided by the sponsor.
DCM II TrialLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Non-ischemic Dilated Cardiomyopathy

Recruiting
Performance of the Cardiac Microcurrent (C-MIC) System With a Less Invasively Placed Left Ventricular Lead
Idiopathic Cardiomyopathy, Left Ventricular (LV) Systolic Dysfunction
Active, not recruitingPhase 1
Treatment of Non-ischemic Cardiomyopathies by Intravenous Extracellular Vesicles of Cardiovascular Progenitor Cells
Heart Failure With Reduced Ejection Fraction
Recruiting
High Fat Diet for Cardiac Metabolic Reprogramming
Non-ischemic Dilated Cardiomyopathy, Heart Failure With Reduced Ejection Fraction
Enrolling by invitation
Mainstreaming Genetic Testing for Non-Ischemic Cardiomyopathy in Western Canada
Nonischemic Cardiomyopathy, Dilated Cardiomyopathy (DCM)
Not yet recruiting
Dilated Cardiomyopathy - Unknown Therapeutic Risk Reduction by Contempary Medication and Implantable Cardioverter-Defibrillators (DUTCH-ICD)
Sudden Cardiac Death

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.

Joshua Hare, MD principal investigator

University of Miami

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing allogeneic human mesenchymal stem cells (hMSCs) in people with Non-ischemic Dilated Cardiomyopathy, run by Joshua M Hare at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 40 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: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

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?

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 LVEF (time frame: Baseline, 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 NCT04476901.

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 29 Sep 2026.