COVID-19 Associated Cardiac InvolvementPhase 3MYOFLAME-19NCT05619653
Myocardial Protection in Patients With Post-acute Inflammatory Cardiac Involvement Due to COVID-19
A Phase 3 study testing Prednisolone and Losartan in people with COVID-19 Associated Cardiac Involvement and Remodeling, Left Ventricle, run by Valentina Puentmann at 5 sites in 2 countries.
Trial summary
Long COVID or Postacute sequelae of COVID-19 infection (PASC) are increasingly recognised complications, defined by lingering symptoms, not present prior to the infection, typically persisting for more than 4 weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- COVID-19 Associated Cardiac Involvement, Remodeling, Left Ventricle, Remodeling, Vascular
- What is being tested?
- Prednisolone and Losartan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 279 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 12 Dec 2022to 31 Mar 2026
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years
- Patients with documented recent COVID19 infection (>4 weeks)
- PASC Syndrome, defined by persistence or new symptoms, not present prior to the infection.
- CMR evidence of inflammatory cardiac involvement at BL by any of the following criteria:
- Increased native T1≥ 1130 ms at 3.0 Tesla (or 1030 ms at 1.5 Tesla) and/or;
- Increased native T2 ≥39.5 ms at 3.0 Tesla (or 49.5 at 1.5 Tesla) and/or
Show all 9Show fewer
- present non-ischaemic myopericardial LGE and/or;
- LVEF ≥45 - ≤50%.
- Willingness to comply with the study procedures and study protocol
Who cannot join
- Severe acute COVID illness requiring hospitalisation
- Known allergy to or intolerance of the study medications
- Symptomatic hypotension (systolic blood pressure less than 90 mm Hg), not reversible with oral hydration
- Any previous or current use of ACE inhibitors, AR Blockers
- Any previous oral prednisolone, or any other immunosuppressive or biological treatment (within prior 10 weeks)
- History or CMR evidence of pre-existing significant heart disease, including:
Show all 25Show fewer
- Known cardiac impairment with LVEF ≤44%
- Congestive heart failure (NYHA III-IV)
- Active heart failure treatment
- Established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease
- Persistent or permanent atrial fibrillation or significant heart rhythm abnormalities
- Congenital or clinically relevant valvular heart disease (moderate or severe)
- Specific cardiomyopathy (hypertrophic, hypertensive heart disease, amyloidosis, previous myocarditis, non-ischaemic dilated cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, non-compaction cardiomyopathy, etc).
- Known significant concomitant diseases that are likely to interfere with the evaluation of the patient's safety and of the study outcome (e.g. diabetes, lung or hepatic disease, epilepsy, psychiatric disorders, renal disease with a current estimated GFR <30 mL/min/1.73 m² using MDRD formula, chronic systemic infection or immunocompromise)
- Exceeding scanner bore and table-holding capacity: Weight >125 kg, BMI > 35 kg/m2
- Contraindications to contrast-enhanced CMR imaging, e.g.
- MR-unsafe implantable device
- known allergy to gadolinium-based contrast agent (CBGA)
- For female participants:
- Pregnant or breastfeeding women
- Persons of childbearing potential not willing to use effective contraception (defined as PEARL index <1 - e.g. contraceptive pill, IUD)
- Known alcohol, drug or chemical abuse
- Patients currently participating in an investigational study or for whom participation is planned.
- Unable to provide written informed consent
- Patients with CMR evidence of structural heart disease or incidental heart rhythm abnormalities will be advised to see their own doctor for further investigation.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Germany4 sites
Institute for experimental and translational cardiovascular imaging
Frankfurt am Main, Hesse, 60596
University Hospital Greifswald
Greifswald, 17475
University Hospital Schleswig-Holstein, Campus KIEL
Kiel, 24105
University Hospital Ulm
Ulm, 89081
About this study
Official title: Randomised Placebo Controlled Clinical Trial of Efficacy of MYOcardial Protection in Patients With Postacute inFLAMmatory Cardiac involvEment Due to COVID-19
Long COVID or Postacute sequelae of COVID-19 infection (PASC) are increasingly recognised complications, defined by lingering symptoms, not present prior to the infection, typically persisting for more than 4 weeks. Cardiac symptoms due to post-acute inflammatory cardiac involvement affect a broad segment of people, who were previously well and may have had only mild acute illness (PASC-cardiovascular syndrome, PASC-CVS). Symptoms may be contiguous with the acute illness, however, more commonly they occur after a delay. Symptoms related to the cardiovascular system include exertional dyspnoea, exercise intolerance chest tightness, pulling or burning chest pain, and palpitations (POTS, exertional tachycardia).
Pathophysiologically, Long COVID relates to small vessel disease (endothelial dysfunction) vascular dysfunction and consequent tissue organ hypoperfusion due to ongoing immune dysregulation. Active organs with high oxygen dependency are most affected (heart, brain, kidneys, muscles, etc.). Thus, cardiac symptoms are often accompanied by manifestations of other organ systems, including fatigue, brain fog, kidney problems, myalgias, skin and joint manifestations, etc, now commonly referred to as the Long COVID or PASC syndrome.
Read more
Phenotypically, PostCOVID Heart involvement is characterised by chronic perivascular and myopericardial inflammation. We and others have shown changes using sensitive cardiac MRI imaging that relate to cardiac symptoms (Puntmann et al, Nature Medicine 2022; Puntmann et al, JAMA Cardiol 2020; Summary of studies included in 2022 ACC PostCOVID Expert Consensus Taskforce Development Statement, JACC 2022, references below).
Early intervention with immunosuppression and antiremodelling therapy may reduce symptoms and development of myocardial impairment, by minimising the disease activity and inducing disease remission. Low-dose maintenance therapy may help to maintain the disease activity at the lowest possible level. The benefits of early initiations of antiremodelling therapy to reduce symptoms of exercise intolerance are well recognised, but not commonly employed outside the classical cardiology contexts, such as heart failure or hypertension. As most patients with inflammatory heart disease only have mild or no structural abnormalities, they are left untreated (standard of care).
The aim of this study is to examine the efficacy of a combined immunosuppressive / antiremodelling therapy in patients with PASC symptoms and inflammatory cardiac involvement determined by CMR, to reduce the symptoms and inflammatory myocardial injury and thereby stop the progression to reduced LVEF, HF and death.
Read the detailed description
Patients with documented COVID-19 infection, experiencing new cardiac symptoms in the aftermath of COVID-19 infection, fulfilling predefined CMR criteria for PostCOVID myocardial involvement and no previously known or demonstrable cardiovascular disease will be randomised to 16-week treatment with Losartan/Prednisolon or placebo. All imaging is conducted with fidelity to standardised imaging protocol. All images are analysed in a dedicated core-lab to confirm eligibility for inclusion. Investigators and participants remain blinded to group allocation and imaging results.
The primary outcome is a change in LVEF from the baseline to 16 weeks measured by MRI.
Secondary outcomes include changes in clinical symptom scores, imaging parameters, CPET (VO2max), as well as outcomes after 1 years time.
- Conditions
- COVID-19 Associated Cardiac Involvement, Remodeling, Left Ventricle, Remodeling, Vascular, Left Ventricular Dysfunction, Exercise Intolerance, Vascular Inflammation
- Being tested
- Prednisolone, Losartan
- Keywords
- long COVID, postCOVID, endothelial dysfunction, myocarditis
- Medical subject headings
- Ventricular Remodeling, Vascular Remodeling, Ventricular Dysfunction, Left, Microvascular Angina, Post-Acute COVID-19 Syndrome, Myocarditis, Pericarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoloneDrug
randomised double-blind, placebo-controlled clinical trial 1:1 randomisation
LosartanDrug
randomised double-blind, placebo-controlled clinical trial 1:1 randomisation
| Study group | Role | What they receive |
|---|---|---|
| Verum | Active comparator | Prednisolone and Losartan Receives: Drug: Prednisolone; Drug: Losartan |
| Placebo | Placebo comparator | Placebo 1 and Placebo 2 Receives: Drug: Prednisolone; Drug: Losartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular ejection fraction
absolute change of LVEF from baseline
Measured: 16 weeks
Secondary outcomes (12)
Scar burden by late gadolinium enhancement (LGE)
mean LGE extent (%) and change thereof from baseline
Measured: 16 weeks
Cardiopulmonary exercise testing (CPET)
Achieved Work rate, VO2max, VCO2 max, RER, AT and Slope and change thereof compared to baseline
Measured: 16 weeks
Mean T1 and T2 mapping
Mean T1 and T2 mapping values (ms) and absolute change thereof compared to baseline
Measured: 16 Weeks
LV Volume (ml/m2) and LV mass (g/m2)
Average LV Volume (ml/m2) and average LV mass (g/m2) and change there of measures from baseline
Measured: 16 Weeks
LV strain %
absolute change of measures from baseline
Measured: 16 Weeks
Aortic stiffness (PWV)
absolute change of measures from baseline
Measured: 16 Weeks
Aortic wall imaging (LGE)
absolute change of measures from baseline
Measured: 16 Weeks
Average Symptom Score (Modified CCS, NYHA, MRC Dyspnea Score, LC Questionnaire (Sudre et al, NM 2020)
change thereof compared to baseline
Measured: at all available time points compared to baseline
HF and MACE Endpoints
proportion of patients with endpoints
Measured: 1 year
Quality of Life assessment
Quality of Life assessment (RAND 36-Item health survey V2.0)
Measured: at all available time points compared to baseline
Compliance and Tolerance of Therapy
Compliance and Tolerance of Therapy
Measured: at all available time points compared to baseline
Assessment of Treatment Response
Number of responders achieving partial or full recovery by imaging markers
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start12 Dec 2022
- Primary completion8 Aug 2025
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for COVID-19 Associated Cardiac InvolvementStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- multicentre randomised double-blind, placebo-controlled clinical trial 1:1 randomisation
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valentina Puentmann
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer, Alcedis GmbH
- Responsible party
- Sponsor-investigator, Valentina Puentmann, Johann Wolfgang Goethe University Hospital
- Investigators
- Valentina Puntmann, MD, PhD, Principal investigator, Goethe University FrankfurtEike Nagel, MD, PhD, Principal investigator, Goethe University Frankfurt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05619653
- Sponsor's protocol ID
- MYOFLAME-19
- Other IDs
- 2022-001682-12
- Acronym
- MYOFLAME-19
- Status last verified
- Dec 2025
- First submitted
- 14 Nov 2022
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Puntmann VO, Martin S, Shchendrygina A, Hoffmann J, Ka MM, Giokoglu E, Vanchin B, Holm N, Karyou A, Laux GS, Arendt C, De Leuw P, Zacharowski K, Khodamoradi Y, Vehreschild MJGT, Rohde G, Zeiher AM, Vogl TJ, Schwenke C, Nagel E. Long-term cardiac pathology in individuals with mild initial COVID-19 illness. Nat Med. 2022 Oct;28(10):2117-2123. doi: 10.1038/s41591-022-02000-0. Epub 2022 Sep 5.
PubMed 36064600Writing Committee; Gluckman TJ, Bhave NM, Allen LA, Chung EH, Spatz ES, Ammirati E, Baggish AL, Bozkurt B, Cornwell WK 3rd, Harmon KG, Kim JH, Lala A, Levine BD, Martinez MW, Onuma O, Phelan D, Puntmann VO, Rajpal S, Taub PR, Verma AK. 2022 ACC Expert Consensus Decision Pathway on Cardiovascular Sequelae of COVID-19 in Adults: Myocarditis and Other Myocardial Involvement, Post-Acute Sequelae of SARS-CoV-2 Infection, and Return to Play: A Report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 2022 May 3;79(17):1717-1756. doi: 10.1016/j.jacc.2022.02.003. Epub 2022 Mar 16. No abstract available.
PubMed 35307156Puntmann VO, Carerj ML, Wieters I, Fahim M, Arendt C, Hoffmann J, Shchendrygina A, Escher F, Vasa-Nicotera M, Zeiher AM, Vehreschild M, Nagel E. Outcomes of Cardiovascular Magnetic Resonance Imaging in Patients Recently Recovered From Coronavirus Disease 2019 (COVID-19). JAMA Cardiol. 2020 Nov 1;5(11):1265-1273. doi: 10.1001/jamacardio.2020.3557.
PubMed 32730619Puntmann VO, Beitzke D, Kammerlander A, Voges I, Gabbert DD, Doerr M, Chamling B, Bozkurt B, Kaski JC, Spatz E, Herrmann E, Rohde G, DeLeuw P, Taylor L, Windemuth-Kieselbach C, Harz C, Santiuste M, Schoeckel L, Hirayama J, Taylor PC, Berry C, Nagel E. Design and rationale of MYOFLAME-19 randomised controlled trial: MYOcardial protection to reduce post-COVID inFLAMmatory heart disease using cardiovascular magnetic resonance Endpoints. J Cardiovasc Magn Reson. 2025 Summer;27(1):101121. doi: 10.1016/j.jocmr.2024.101121. Epub 2024 Oct 29.
PubMed 39481808Puntmann VO, Nagel E, Beitzke D, Kammerlander A, Voges I, Doerr M, Chamling B, Bozkurt B, Kaski JC, Spatz E, Herrmann E, Rohde G, DeLeuw P, Windemuth-Kieselbach C, Eckhardt S, Taylor PC, Berry C. Losartan and prednisolone for post-COVID syndrome and cardiac inflammation: a randomized, double-blind, placebo-controlled trial. Nat Commun. 2026 Jul 30;17(1):7599. doi: 10.1038/s41467-026-75991-w.
PubMed 42533000
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Placebo Controlled Clinical Trial of Efficacy of MYOcardial Protection in Patients With Postacute inFLAMmatory Cardiac involvEment Due to COVID-19
- ClinicalTrials.gov ID
- NCT05619653
- Acronym / sponsor ID
- MYOFLAME-19 / MYOFLAME-19
- Conditions
- COVID-19 Associated Cardiac Involvement, Remodeling, Left Ventricle, Remodeling, Vascular, Left Ventricular Dysfunction, Exercise Intolerance, Vascular Inflammation
- Keywords
- long COVID, postCOVID, endothelial dysfunction, myocarditis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 279 participants (actual)
- Lead sponsor
- Valentina PuentmannUniversity, hospital or other
- Collaborators
- Bayer, Alcedis GmbH
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 8 Aug 2025 (actual)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 17 Nov 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.
Long COVID or Postacute sequelae of COVID-19 infection (PASC) are increasingly recognised complications, defined by lingering symptoms, not present prior to the infection, typically persisting for more than 4 weeks. Cardiac symptoms due to post-acute inflammatory cardiac involvement affect a broad segment of people, who were previously well and may have had only mild acute illness (PASC-cardiovascular syndrome, PASC-CVS). Symptoms may be contiguous with the acute illness, however, more commonly they occur after a delay. Symptoms related to the cardiovascular system include exertional dyspnoea, exercise intolerance chest tightness, pulling or burning chest pain, and palpitations (POTS, exertional tachycardia).
Pathophysiologically, Long COVID relates to small vessel disease (endothelial dysfunction) vascular dysfunction and consequent tissue organ hypoperfusion due to ongoing immune dysregulation. Active organs with high oxygen dependency are most affected (heart, brain, kidneys, muscles, etc.). Thus, cardiac symptoms are often accompanied by manifestations of other organ systems, including fatigue, brain fog, kidney problems, myalgias, skin and joint manifestations, etc, now commonly referred to as the Long COVID or PASC syndrome.
Phenotypically, PostCOVID Heart involvement is characterised by chronic perivascular and myopericardial inflammation. We and others have shown changes using sensitive cardiac MRI imaging that relate to cardiac symptoms (Puntmann et al, Nature Medicine 2022; Puntmann et al, JAMA Cardiol 2020; Summary of studies included in 2022 ACC PostCOVID Expert Consensus Taskforce Development Statement, JACC 2022, references below).
Early intervention with immunosuppression and antiremodelling therapy may reduce symptoms and development of myocardial impairment, by minimising the disease activity and inducing disease remission. Low-dose maintenance therapy may help to maintain the disease activity at the lowest possible level. The benefits of early initiations of antiremodelling therapy to reduce symptoms of exercise intolerance are well recognised, but not commonly employed outside the classical cardiology contexts, such as heart failure or hypertension. As most patients with inflammatory heart disease only have mild or no structural abnormalities, they are left untreated (standard of care).
The aim of this study is to examine the efficacy of a combined immunosuppressive / antiremodelling therapy in patients with PASC symptoms and inflammatory cardiac involvement determined by CMR, to reduce the symptoms and inflammatory myocardial injury and thereby stop the progression to reduced LVEF, HF and death.
Detailed description
Patients with documented COVID-19 infection, experiencing new cardiac symptoms in the aftermath of COVID-19 infection, fulfilling predefined CMR criteria for PostCOVID myocardial involvement and no previously known or demonstrable cardiovascular disease will be randomised to 16-week treatment with Losartan/Prednisolon or placebo. All imaging is conducted with fidelity to standardised imaging protocol. All images are analysed in a dedicated core-lab to confirm eligibility for inclusion. Investigators and participants remain blinded to group allocation and imaging results.
The primary outcome is a change in LVEF from the baseline to 16 weeks measured by MRI.
Secondary outcomes include changes in clinical symptom scores, imaging parameters, CPET (VO2max), as well as outcomes after 1 years time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- multicentre randomised double-blind, placebo-controlled clinical trial 1:1 randomisation
| Arm | Type | Receives |
|---|---|---|
| Verum | Active comparator | Drug: Prednisolone, Drug: LosartanPrednisolone and Losartan |
| Placebo | Placebo comparator | Drug: Prednisolone, Drug: LosartanPlacebo 1 and Placebo 2 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients ≥ 18 years
- Patients with documented recent COVID19 infection (>4 weeks)
- PASC Syndrome, defined by persistence or new symptoms, not present prior to the infection.
- CMR evidence of inflammatory cardiac involvement at BL by any of the following criteria:
- Increased native T1≥ 1130 ms at 3.0 Tesla (or 1030 ms at 1.5 Tesla) and/or;
Key exclusion criteria (25 listed)
- Severe acute COVID illness requiring hospitalisation
- Known allergy to or intolerance of the study medications
- Symptomatic hypotension (systolic blood pressure less than 90 mm Hg), not reversible with oral hydration
- Any previous or current use of ACE inhibitors, AR Blockers
- Any previous oral prednisolone, or any other immunosuppressive or biological treatment (within prior 10 weeks)
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 |
|---|---|---|
| Prednisolonerandomised double-blind, placebo-controlled clinical trial 1:1 randomisation | Drug | Placebo, Verum |
| Losartanrandomised double-blind, placebo-controlled clinical trial 1:1 randomisation | Drug | Placebo, Verum |
Primary outcome
Left ventricular ejection fraction
Time frame: 16 weeks
absolute change of LVEF from baseline
12 secondary outcomes
Scar burden by late gadolinium enhancement (LGE)
Time frame: 16 weeks
Cardiopulmonary exercise testing (CPET)
Time frame: 16 weeks
Mean T1 and T2 mapping
Time frame: 16 Weeks
LV Volume (ml/m2) and LV mass (g/m2)
Time frame: 16 Weeks
LV strain %
Time frame: 16 Weeks
Aortic stiffness (PWV)
Time frame: 16 Weeks
Aortic wall imaging (LGE)
Time frame: 16 Weeks
Average Symptom Score (Modified CCS, NYHA, MRC Dyspnea Score, LC Questionnaire (Sudre et al, NM 2020)
Time frame: at all available time points compared to baseline
HF and MACE Endpoints
Time frame: 1 year
Quality of Life assessment
Time frame: at all available time points compared to baseline
Compliance and Tolerance of Therapy
Time frame: at all available time points compared to baseline
Assessment of Treatment Response
Time frame: 16 weeks
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 9 Dec 2025.
- Background: PubMed 36064600Puntmann VO, Martin S, Shchendrygina A, Hoffmann J, Ka MM, Giokoglu E, Vanchin B, Holm N, Karyou A, Laux GS, Arendt C, De Leuw P, Zacharowski K, Khodamoradi Y, Vehreschild MJGT, Rohde G, Zeiher AM, Vogl TJ, Schwenke C, Nagel E. Long-term cardiac pathology in individuals with mild initial COVID-19 illness. Nat Med. 2022 Oct;28(10):2117-2123. doi: 10.1038/s41591-022-02000-0. Epub 2022 Sep 5.
- Background: PubMed 35307156Writing Committee; Gluckman TJ, Bhave NM, Allen LA, Chung EH, Spatz ES, Ammirati E, Baggish AL, Bozkurt B, Cornwell WK 3rd, Harmon KG, Kim JH, Lala A, Levine BD, Martinez MW, Onuma O, Phelan D, Puntmann VO, Rajpal S, Taub PR, Verma AK. 2022 ACC Expert Consensus Decision Pathway on Cardiovascular Sequelae of COVID-19 in Adults: Myocarditis and Other Myocardial Involvement, Post-Acute Sequelae of SARS-CoV-2 Infection, and Return to Play: A Report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 2022 May 3;79(17):1717-1756. doi: 10.1016/j.jacc.2022.02.003. Epub 2022 Mar 16. No abstract available.
- Background: PubMed 32730619Puntmann VO, Carerj ML, Wieters I, Fahim M, Arendt C, Hoffmann J, Shchendrygina A, Escher F, Vasa-Nicotera M, Zeiher AM, Vehreschild M, Nagel E. Outcomes of Cardiovascular Magnetic Resonance Imaging in Patients Recently Recovered From Coronavirus Disease 2019 (COVID-19). JAMA Cardiol. 2020 Nov 1;5(11):1265-1273. doi: 10.1001/jamacardio.2020.3557.
- Background: PubMed 39481808Puntmann VO, Beitzke D, Kammerlander A, Voges I, Gabbert DD, Doerr M, Chamling B, Bozkurt B, Kaski JC, Spatz E, Herrmann E, Rohde G, DeLeuw P, Taylor L, Windemuth-Kieselbach C, Harz C, Santiuste M, Schoeckel L, Hirayama J, Taylor PC, Berry C, Nagel E. Design and rationale of MYOFLAME-19 randomised controlled trial: MYOcardial protection to reduce post-COVID inFLAMmatory heart disease using cardiovascular magnetic resonance Endpoints. J Cardiovasc Magn Reson. 2025 Summer;27(1):101121. doi: 10.1016/j.jocmr.2024.101121. Epub 2024 Oct 29.
- Derived from this study: PubMed 42533000Puntmann VO, Nagel E, Beitzke D, Kammerlander A, Voges I, Doerr M, Chamling B, Bozkurt B, Kaski JC, Spatz E, Herrmann E, Rohde G, DeLeuw P, Windemuth-Kieselbach C, Eckhardt S, Taylor PC, Berry C. Losartan and prednisolone for post-COVID syndrome and cardiac inflammation: a randomized, double-blind, placebo-controlled trial. Nat Commun. 2026 Jul 30;17(1):7599. doi: 10.1038/s41467-026-75991-w.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Valentina Puntmann, MD, PhD principal investigator
Goethe University Frankfurt
Eike Nagel, MD, PhD principal investigator
Goethe University Frankfurt
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prednisolone and Losartan in people with COVID-19 Associated Cardiac Involvement and Remodeling, Left Ventricle, run by Valentina Puentmann at 5 sites in 2 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 25 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 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Austria. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Left ventricular ejection fraction (time frame: 16 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 NCT05619653, which also lists 5 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 9 Dec 2025.