Ventricular ArrythmiaPhase 4IMMUNE VTNCT06635863
Comparing Immune System Suppression to Medication for Unexplained Heart Function and Irregular Heartbeat
A Phase 4 study testing Prednisone 40mg in people with Ventricular Arrythmia and Non-ischemic Cardiomyopathy, run by Roderick Tung at 1 site in United States.
Trial summary
Ventricular tachycardia (VT, a potentially fatal condition where the ventricle of the heart beats rapidly) superimposed on non-ischemic cardiomyopathy (NICM, a disease of heart with broad etiologies except coronary artery disease). This disease has been associated with inflammation in the heart. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Arrythmia, Non-ischemic Cardiomyopathy, Arrhythmogenic Inflammatory Cardiomyopathy
- What is being tested?
- Prednisone 40mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2024to Oct 2027
- Phase
- Phase 4
- 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
- 18 years of age, all races, all gender
- LV systolic function \< 50%
- Optimized GDMT Per physicians' discretion (SOC treatment)
- No evidence of ischemic cardiomyopathy
- No evidence of obstructive coronary disease
- Viral panel negative
Show all 10Show fewer
- NYHA class II, III and ambulatory class IV heart failure
- History of VA (documentation of Sustained VT last more than 30 seconds)
- Heart inflammation confirmed by PET scan
- Steroid use within 12 months prior to of date of consent
Who cannot join
- Life expectancy less than 24 months
- Pregnancy
- Contra indications or intolerance of prednisone or any excipients in the formulation
- Hypothalamic-pituitary-adrenal axis suppression, Cushing's syndrome, active infection, glaucoma or any other pathology where corticosteroids are not recommended.
- Any patient with HIV, low white blood cells, and chronic infection (active fungal, TB, Valley fever)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Banner - University Medical Center, Phoenix campus
Phoenix, Arizona, 85006
About this study
Official title: Immunosuppression Versus Medical Therapy for UN-explained Low Ejection Fraction and VT
Ventricular tachycardia (VT, a potentially fatal condition where the ventricle of the heart beats rapidly) superimposed on non-ischemic cardiomyopathy (NICM, a disease of heart with broad etiologies except coronary artery disease). This disease has been associated with inflammation in the heart.
The purpose of this study is to assess the benefit of immunosuppressive therapy to suppress the VT, improve heart function, avoid invasive intervention and hospitalization. Positron Emission Tomography (PET) imaging shows inflammation in the heart. After enrollment, baseline tests (including physical exams, blood tests, genetic test, electrocardiography, echocardiography) will be done. Next, will be an 8-week medication regimen which contains either immunosuppressive drugs or standard GDMT without immunosuppressant medication. Some of the examinations will be repeated during the study to evaluate the treatment response and monitor any adverse events.
Read the detailed description
Ventricular arrhythmia (VT) is a well-established consequence in patients with non-ischemic cardiomyopathy (NICM). NICM is a broad category that includes a wide spectrum of causes, which may include: bacterial, viral toxin mediated and immune mediated and "unexplained" when coronary disease has been excluded. The pathophysiology of NICM is not well understood but inflammatory responses with macrophage recruitment during remodeling have been described. On the other hand, an infectious trigger i.e. myocarditis may be the inciting event for the development of cardiomyopathy. A previous study by Tung et al showed that nearly 50% of patients with unexplained cardiomyopathy and ventricular arrhythmias presented ongoing focal myocardial inflammation on PET. To date, targeting inflammation as a substrate in order to reduce burden of ventricular tachycardia has not been investigated in randomized prospective fashion.
The TIMIC trial was one of the few randomized studies to examine long-term benefit of immunosuppressive therapies in patients with virus-negative NICM. A moderate improvement in Left Ventricular Ejection Fraction (LVEF) over 6 months after initiation of immunosuppressive therapy was demonstrated in this study but current guidelines do not routinely recommend anti-inflammatory therapies for NICM. While considered to be gold standard, endomyocardial biopsy can often times be incorrect due to sampling error and typically is not performed multiple times in patient with chronic non-ischemic cardiomyopathy. Fasting Fluorodeoxyglucose (FDG)-positron emission tomography (PET) is an emerging imaging modality to identify and monitor abnormal metabolic patterns of the myocardium. By exploiting the metabolic demand of inflammatory tissue with macrophage recruitment, PET imaging is emerging as the preferred modality to diagnose and measure response to therapy for patients with myocarditis and sarcoidosis. A recent study by Kandolin et al in Finland showed that the incidence of cardiac sarcoidosis has increased by 20-fold over the past two decades.
FDG-PET may reveal inflammation as a central pathophysiologic mechanism in a significant proportion of patients with unexplained cardiomyopathy and VT. Potential innovative insights from the trial will be to identify the underlying pathogenesis of idiopathic cardiomyopathy and assess whether immunosuppression changes the clinical course of patients with identified arrhythmogenic cardiomyopathy. Aside from guideline-direct medical therapy (GDMT), antiarrhythmic agents, and catheter ablation, there are no disease-specific therapies for patients with VT and NICM. Prospective studies that evaluate the incidence of occult inflammation and clinical response to anti-inflammatory and immunosuppressive therapy have not been performed to date and are warranted for the emerging NICM population referred for advanced heart failure and arrhythmia management.
- Conditions
- Ventricular Arrythmia, Non-ischemic Cardiomyopathy, Arrhythmogenic Inflammatory Cardiomyopathy
- Being tested
- Prednisone 40mg
- Keywords
- immunosuppressive therapy, immunomodulatory, inflammation by FDG, guideline-direct medical therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prednisone 40mgDrug
Prednisone 40mg x 8weeks
| Study group | Role | What they receive |
|---|---|---|
| Immunosuppression | Experimental | Prednisone 40mg x 8weeks + GDMT Receives: Drug: Prednisone 40mg |
| Standard of Care | No intervention | GDMT alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Burden of ventricular arrhythmias
Documented sustained monomorphic ventricular tachycardia \>30 seconds or any appropriate defibrillator therapy (shock or antitachycardia pacing).
Measured: 12 months (8 weeks and 6 months)
Change in left ventricular ejection fraction (LVEF)
Left ventricular ejection fraction measured with Simpson method with echocardiography.
Measured: 12 months (8 weeks and 6 months)
Change in QRS duration
QRS duration (milliseconds) measured with a 12-lead ECG.
Measured: 12 months (8 weeks and 6 months)
Change in FDG (18F-fluorodeoxyglucose) uptake
Change in FDG uptake compared to initial uptake assessed with 18F-fluorodeoxyglucose PET (FDG-PET). Myocardial FDG uptake will be reported as non, focal or diffuse and/or isolated with focal pattern.
Measured: 12 months
Secondary outcomes (4)
Cardiovascular hospitalization
Patient hospitalization (yes/no) due to a cardiovascular reason. Cardiovascular hospitalization is defined as a hospital admission after the randomized procedure for heart failure, treatment associated complication, or arrhythmia-related causes during the follow-up period.
Measured: 6 months and 12 months.
Need for catheter ablation
Need for catheter ablation (yes/no) due to ventricular arrhythmias.
Measured: 6 months and 12 months.
NYHA functional class
New York Heart Association functional class I, II, III or IV.
Measured: 6 months and 12 months
Survival
Freedom from all-cause mortality and cardiac transplant.
Measured: 6 months 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 2024
- Study start1 Nov 2024
- Primary completionOct 2026 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Ventricular ArrythmiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roderick Tung
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Roderick Tung, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635863
- Sponsor's protocol ID
- STUDY00003729
- Acronym
- IMMUNE VT
- Status last verified
- May 2026
- First submitted
- 8 Oct 2024
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the study is completed, the de-identified, archived data will be stored within REDCap, for use by other researchers including those outside of the study, but only within the University of Arizona. The consent for the study includes information that de-identified data may be used for future unspecified research.
Publications
Tung R, Bauer B, Schelbert H, Lynch JP 3rd, Auerbach M, Gupta P, Schiepers C, Chan S, Ferris J, Barrio M, Ajijola O, Bradfield J, Shivkumar K. Incidence of abnormal positron emission tomography in patients with unexplained cardiomyopathy and ventricular arrhythmias: The potential role of occult inflammation in arrhythmogenesis. Heart Rhythm. 2015 Dec;12(12):2488-98. doi: 10.1016/j.hrthm.2015.08.014. Epub 2015 Aug 10.
PubMed 26272522Belperio JA, Shaikh F, Abtin FG, Fishbein MC, Weigt SS, Saggar R, Lynch JP 3rd. Diagnosis and Treatment of Pulmonary Sarcoidosis: A Review. JAMA. 2022 Mar 1;327(9):856-867. doi: 10.1001/jama.2022.1570.
PubMed 35230389Rahaghi FF, Baughman RP, Saketkoo LA, Sweiss NJ, Barney JB, Birring SS, Costabel U, Crouser ED, Drent M, Gerke AK, Grutters JC, Hamzeh NY, Huizar I, Ennis James W 4th, Kalra S, Kullberg S, Li H, Lower EE, Maier LA, Mirsaeidi M, Muller-Quernheim J, Carmona Porquera EM, Samavati L, Valeyre D, Scholand MB. Delphi consensus recommendations for a treatment algorithm in pulmonary sarcoidosis. Eur Respir Rev. 2020 Mar 20;29(155):190146. doi: 10.1183/16000617.0146-2019. Print 2020 Mar 31.
PubMed 32198218Melani AS, Bigliazzi C, Cimmino FA, Bergantini L, Bargagli E. A Comprehensive Review of Sarcoidosis Treatment for Pulmonologists. Pulm Ther. 2021 Dec;7(2):325-344. doi: 10.1007/s41030-021-00160-x. Epub 2021 Jun 18.
PubMed 34143362Kandolin R, Lehtonen J, Airaksinen J, Vihinen T, Miettinen H, Ylitalo K, Kaikkonen K, Tuohinen S, Haataja P, Kerola T, Kokkonen J, Pelkonen M, Pietila-Effati P, Utrianen S, Kupari M. Cardiac sarcoidosis: epidemiology, characteristics, and outcome over 25 years in a nationwide study. Circulation. 2015 Feb 17;131(7):624-32. doi: 10.1161/CIRCULATIONAHA.114.011522. Epub 2014 Dec 19.
PubMed 25527698Ishimaru S, Tsujino I, Takei T, Tsukamoto E, Sakaue S, Kamigaki M, Ito N, Ohira H, Ikeda D, Tamaki N, Nishimura M. Focal uptake on 18F-fluoro-2-deoxyglucose positron emission tomography images indicates cardiac involvement of sarcoidosis. Eur Heart J. 2005 Aug;26(15):1538-43. doi: 10.1093/eurheartj/ehi180. Epub 2005 Apr 4.
PubMed 15809286Chareonthaitawee P, Beanlands RS, Chen W, Dorbala S, Miller EJ, Murthy VL, Birnie DH, Chen ES, Cooper LT, Tung RH, White ES, Borges-Neto S, Di Carli MF, Gropler RJ, Ruddy TD, Schindler TH, Blankstein R; EXPERT CONTENT REVIEWERS. Joint SNMMI-ASNC Expert Consensus Document on the Role of 18F-FDG PET/CT in Cardiac Sarcoid Detection and Therapy Monitoring. J Nucl Med. 2017 Aug;58(8):1341-1353. doi: 10.2967/jnumed.117.196287. No abstract available.
PubMed 28765228Kebed KY, Carter SV, Flatley E, Ward RP, Moss JD, Appelbaum DE, Singh A, Lang RM, Tung R, Patel AR. Prevalence of newly diagnosed sarcoidosis in patients with ventricular arrhythmias: a cardiac magnetic resonance and 18F-FDG cardiac PET study. Int J Cardiovasc Imaging. 2021 Apr;37(4):1361-1369. doi: 10.1007/s10554-020-02090-2. Epub 2020 Nov 22.
PubMed 33225427Youssef G, Leung E, Mylonas I, Nery P, Williams K, Wisenberg G, Gulenchyn KY, Dekemp RA, Dasilva J, Birnie D, Wells GA, Beanlands RS. The use of 18F-FDG PET in the diagnosis of cardiac sarcoidosis: a systematic review and metaanalysis including the Ontario experience. J Nucl Med. 2012 Feb;53(2):241-8. doi: 10.2967/jnumed.111.090662. Epub 2012 Jan 6.
PubMed 22228794Wicks EC, Menezes LJ, Barnes A, Mohiddin SA, Sekhri N, Porter JC, Booth HL, Garrett E, Patel RS, Pavlou M, Groves AM, Elliott PM. Diagnostic accuracy and prognostic value of simultaneous hybrid 18F-fluorodeoxyglucose positron emission tomography/magnetic resonance imaging in cardiac sarcoidosis. Eur Heart J Cardiovasc Imaging. 2018 Jul 1;19(7):757-767. doi: 10.1093/ehjci/jex340.
PubMed 29319785Palmisano A, Vignale D, Peretto G, Busnardo E, Calcagno C, Campochiaro C, De Luca G, Sala S, Ferro P, Basso C, Del Maschio A, De Cobelli F, Esposito A. Hybrid FDG-PET/MR or FDG-PET/CT to Detect Disease Activity in Patients With Persisting Arrhythmias After Myocarditis. JACC Cardiovasc Imaging. 2021 Jan;14(1):288-292. doi: 10.1016/j.jcmg.2020.03.009. Epub 2020 Apr 15. No abstract available.
PubMed 32305473Arbelo E, Protonotarios A, Gimeno JR, Arbustini E, Barriales-Villa R, Basso C, Bezzina CR, Biagini E, Blom NA, de Boer RA, De Winter T, Elliott PM, Flather M, Garcia-Pavia P, Haugaa KH, Ingles J, Jurcut RO, Klaassen S, Limongelli G, Loeys B, Mogensen J, Olivotto I, Pantazis A, Sharma S, Van Tintelen JP, Ware JS, Kaski JP; ESC Scientific Document Group. 2023 ESC Guidelines for the management of cardiomyopathies. Eur Heart J. 2023 Oct 1;44(37):3503-3626. doi: 10.1093/eurheartj/ehad194. No abstract available.
PubMed 37622657Al-Khatib SM, Stevenson WG, Ackerman MJ, Bryant WJ, Callans DJ, Curtis AB, Deal BJ, Dickfeld T, Field ME, Fonarow GC, Gillis AM, Granger CB, Hammill SC, Hlatky MA, Joglar JA, Kay GN, Matlock DD, Myerburg RJ, Page RL. 2017 AHA/ACC/HRS Guideline for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2018 Oct 2;72(14):e91-e220. doi: 10.1016/j.jacc.2017.10.054. Epub 2018 Aug 16. No abstract available.
PubMed 29097296Frustaci A, Russo MA, Chimenti C. Randomized study on the efficacy of immunosuppressive therapy in patients with virus-negative inflammatory cardiomyopathy: the TIMIC study. Eur Heart J. 2009 Aug;30(16):1995-2002. doi: 10.1093/eurheartj/ehp249. Epub 2009 Jun 25.
PubMed 19556262Chimenti C, Russo MA, Frustaci A. Immunosuppressive therapy in virus-negative inflammatory cardiomyopathy: 20-year follow-up of the TIMIC trial. Eur Heart J. 2022 Sep 21;43(36):3463-3473. doi: 10.1093/eurheartj/ehac348.
PubMed 35831932
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunosuppression Versus Medical Therapy for UN-explained Low Ejection Fraction and VT
- ClinicalTrials.gov ID
- NCT06635863
- Acronym / sponsor ID
- IMMUNE VT / STUDY00003729
- Conditions
- Ventricular Arrythmia, Non-ischemic Cardiomyopathy, Arrhythmogenic Inflammatory Cardiomyopathy
- Keywords
- immunosuppressive therapy, immunomodulatory, inflammation by FDG, guideline-direct medical therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Roderick TungUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 10 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ventricular tachycardia (VT, a potentially fatal condition where the ventricle of the heart beats rapidly) superimposed on non-ischemic cardiomyopathy (NICM, a disease of heart with broad etiologies except coronary artery disease). This disease has been associated with inflammation in the heart.
The purpose of this study is to assess the benefit of immunosuppressive therapy to suppress the VT, improve heart function, avoid invasive intervention and hospitalization. Positron Emission Tomography (PET) imaging shows inflammation in the heart. After enrollment, baseline tests (including physical exams, blood tests, genetic test, electrocardiography, echocardiography) will be done. Next, will be an 8-week medication regimen which contains either immunosuppressive drugs or standard GDMT without immunosuppressant medication. Some of the examinations will be repeated during the study to evaluate the treatment response and monitor any adverse events.
Detailed description
Ventricular arrhythmia (VT) is a well-established consequence in patients with non-ischemic cardiomyopathy (NICM). NICM is a broad category that includes a wide spectrum of causes, which may include: bacterial, viral toxin mediated and immune mediated and "unexplained" when coronary disease has been excluded. The pathophysiology of NICM is not well understood but inflammatory responses with macrophage recruitment during remodeling have been described. On the other hand, an infectious trigger i.e. myocarditis may be the inciting event for the development of cardiomyopathy. A previous study by Tung et al showed that nearly 50% of patients with unexplained cardiomyopathy and ventricular arrhythmias presented ongoing focal myocardial inflammation on PET. To date, targeting inflammation as a substrate in order to reduce burden of ventricular tachycardia has not been investigated in randomized prospective fashion.
The TIMIC trial was one of the few randomized studies to examine long-term benefit of immunosuppressive therapies in patients with virus-negative NICM. A moderate improvement in Left Ventricular Ejection Fraction (LVEF) over 6 months after initiation of immunosuppressive therapy was demonstrated in this study but current guidelines do not routinely recommend anti-inflammatory therapies for NICM. While considered to be gold standard, endomyocardial biopsy can often times be incorrect due to sampling error and typically is not performed multiple times in patient with chronic non-ischemic cardiomyopathy. Fasting Fluorodeoxyglucose (FDG)-positron emission tomography (PET) is an emerging imaging modality to identify and monitor abnormal metabolic patterns of the myocardium. By exploiting the metabolic demand of inflammatory tissue with macrophage recruitment, PET imaging is emerging as the preferred modality to diagnose and measure response to therapy for patients with myocarditis and sarcoidosis. A recent study by Kandolin et al in Finland showed that the incidence of cardiac sarcoidosis has increased by 20-fold over the past two decades.
FDG-PET may reveal inflammation as a central pathophysiologic mechanism in a significant proportion of patients with unexplained cardiomyopathy and VT. Potential innovative insights from the trial will be to identify the underlying pathogenesis of idiopathic cardiomyopathy and assess whether immunosuppression changes the clinical course of patients with identified arrhythmogenic cardiomyopathy. Aside from guideline-direct medical therapy (GDMT), antiarrhythmic agents, and catheter ablation, there are no disease-specific therapies for patients with VT and NICM. Prospective studies that evaluate the incidence of occult inflammation and clinical response to anti-inflammatory and immunosuppressive therapy have not been performed to date and are warranted for the emerging NICM population referred for advanced heart failure and arrhythmia management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immunosuppression | Experimental | Drug: Prednisone 40mgPrednisone 40mg x 8weeks + GDMT |
| Standard of Care | No intervention | –GDMT alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18 years of age, all races, all gender
- LV systolic function \< 50%
- Optimized GDMT Per physicians' discretion (SOC treatment)
- No evidence of ischemic cardiomyopathy
- No evidence of obstructive coronary disease
Key exclusion criteria (5 listed)
- Life expectancy less than 24 months
- Pregnancy
- Contra indications or intolerance of prednisone or any excipients in the formulation
- Hypothalamic-pituitary-adrenal axis suppression, Cushing's syndrome, active infection, glaucoma or any other pathology where corticosteroids are not recommended.
- Any patient with HIV, low white blood cells, and chronic infection (active fungal, TB, Valley fever)
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 |
|---|---|---|
| Prednisone 40mgPrednisone 40mg x 8weeks | Drug | Immunosuppression |
Primary outcome
Burden of ventricular arrhythmias
Time frame: 12 months (8 weeks and 6 months)
Documented sustained monomorphic ventricular tachycardia \>30 seconds or any appropriate defibrillator therapy (shock or antitachycardia pacing).
Change in left ventricular ejection fraction (LVEF)
Time frame: 12 months (8 weeks and 6 months)
Left ventricular ejection fraction measured with Simpson method with echocardiography.
Change in QRS duration
Time frame: 12 months (8 weeks and 6 months)
QRS duration (milliseconds) measured with a 12-lead ECG.
Change in FDG (18F-fluorodeoxyglucose) uptake
Time frame: 12 months
Change in FDG uptake compared to initial uptake assessed with 18F-fluorodeoxyglucose PET (FDG-PET). Myocardial FDG uptake will be reported as non, focal or diffuse and/or isolated with focal pattern.
4 secondary outcomes
Cardiovascular hospitalization
Time frame: 6 months and 12 months.
Need for catheter ablation
Time frame: 6 months and 12 months.
NYHA functional class
Time frame: 6 months and 12 months
Survival
Time frame: 6 months 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 27 Jul 2026.
- Background: PubMed 26272522Tung R, Bauer B, Schelbert H, Lynch JP 3rd, Auerbach M, Gupta P, Schiepers C, Chan S, Ferris J, Barrio M, Ajijola O, Bradfield J, Shivkumar K. Incidence of abnormal positron emission tomography in patients with unexplained cardiomyopathy and ventricular arrhythmias: The potential role of occult inflammation in arrhythmogenesis. Heart Rhythm. 2015 Dec;12(12):2488-98. doi: 10.1016/j.hrthm.2015.08.014. Epub 2015 Aug 10.
- Background: PubMed 35230389Belperio JA, Shaikh F, Abtin FG, Fishbein MC, Weigt SS, Saggar R, Lynch JP 3rd. Diagnosis and Treatment of Pulmonary Sarcoidosis: A Review. JAMA. 2022 Mar 1;327(9):856-867. doi: 10.1001/jama.2022.1570.
- Background: PubMed 32198218Rahaghi FF, Baughman RP, Saketkoo LA, Sweiss NJ, Barney JB, Birring SS, Costabel U, Crouser ED, Drent M, Gerke AK, Grutters JC, Hamzeh NY, Huizar I, Ennis James W 4th, Kalra S, Kullberg S, Li H, Lower EE, Maier LA, Mirsaeidi M, Muller-Quernheim J, Carmona Porquera EM, Samavati L, Valeyre D, Scholand MB. Delphi consensus recommendations for a treatment algorithm in pulmonary sarcoidosis. Eur Respir Rev. 2020 Mar 20;29(155):190146. doi: 10.1183/16000617.0146-2019. Print 2020 Mar 31.
- Background: PubMed 34143362Melani AS, Bigliazzi C, Cimmino FA, Bergantini L, Bargagli E. A Comprehensive Review of Sarcoidosis Treatment for Pulmonologists. Pulm Ther. 2021 Dec;7(2):325-344. doi: 10.1007/s41030-021-00160-x. Epub 2021 Jun 18.
- Background: PubMed 25527698Kandolin R, Lehtonen J, Airaksinen J, Vihinen T, Miettinen H, Ylitalo K, Kaikkonen K, Tuohinen S, Haataja P, Kerola T, Kokkonen J, Pelkonen M, Pietila-Effati P, Utrianen S, Kupari M. Cardiac sarcoidosis: epidemiology, characteristics, and outcome over 25 years in a nationwide study. Circulation. 2015 Feb 17;131(7):624-32. doi: 10.1161/CIRCULATIONAHA.114.011522. Epub 2014 Dec 19.
- Background: PubMed 15809286Ishimaru S, Tsujino I, Takei T, Tsukamoto E, Sakaue S, Kamigaki M, Ito N, Ohira H, Ikeda D, Tamaki N, Nishimura M. Focal uptake on 18F-fluoro-2-deoxyglucose positron emission tomography images indicates cardiac involvement of sarcoidosis. Eur Heart J. 2005 Aug;26(15):1538-43. doi: 10.1093/eurheartj/ehi180. Epub 2005 Apr 4.
- Background: PubMed 28765228Chareonthaitawee P, Beanlands RS, Chen W, Dorbala S, Miller EJ, Murthy VL, Birnie DH, Chen ES, Cooper LT, Tung RH, White ES, Borges-Neto S, Di Carli MF, Gropler RJ, Ruddy TD, Schindler TH, Blankstein R; EXPERT CONTENT REVIEWERS. Joint SNMMI-ASNC Expert Consensus Document on the Role of 18F-FDG PET/CT in Cardiac Sarcoid Detection and Therapy Monitoring. J Nucl Med. 2017 Aug;58(8):1341-1353. doi: 10.2967/jnumed.117.196287. No abstract available.
- Background: PubMed 33225427Kebed KY, Carter SV, Flatley E, Ward RP, Moss JD, Appelbaum DE, Singh A, Lang RM, Tung R, Patel AR. Prevalence of newly diagnosed sarcoidosis in patients with ventricular arrhythmias: a cardiac magnetic resonance and 18F-FDG cardiac PET study. Int J Cardiovasc Imaging. 2021 Apr;37(4):1361-1369. doi: 10.1007/s10554-020-02090-2. Epub 2020 Nov 22.
- Background: PubMed 22228794Youssef G, Leung E, Mylonas I, Nery P, Williams K, Wisenberg G, Gulenchyn KY, Dekemp RA, Dasilva J, Birnie D, Wells GA, Beanlands RS. The use of 18F-FDG PET in the diagnosis of cardiac sarcoidosis: a systematic review and metaanalysis including the Ontario experience. J Nucl Med. 2012 Feb;53(2):241-8. doi: 10.2967/jnumed.111.090662. Epub 2012 Jan 6.
- Background: PubMed 29319785Wicks EC, Menezes LJ, Barnes A, Mohiddin SA, Sekhri N, Porter JC, Booth HL, Garrett E, Patel RS, Pavlou M, Groves AM, Elliott PM. Diagnostic accuracy and prognostic value of simultaneous hybrid 18F-fluorodeoxyglucose positron emission tomography/magnetic resonance imaging in cardiac sarcoidosis. Eur Heart J Cardiovasc Imaging. 2018 Jul 1;19(7):757-767. doi: 10.1093/ehjci/jex340.
- Background: PubMed 32305473Palmisano A, Vignale D, Peretto G, Busnardo E, Calcagno C, Campochiaro C, De Luca G, Sala S, Ferro P, Basso C, Del Maschio A, De Cobelli F, Esposito A. Hybrid FDG-PET/MR or FDG-PET/CT to Detect Disease Activity in Patients With Persisting Arrhythmias After Myocarditis. JACC Cardiovasc Imaging. 2021 Jan;14(1):288-292. doi: 10.1016/j.jcmg.2020.03.009. Epub 2020 Apr 15. No abstract available.
- Background: PubMed 37622657Arbelo E, Protonotarios A, Gimeno JR, Arbustini E, Barriales-Villa R, Basso C, Bezzina CR, Biagini E, Blom NA, de Boer RA, De Winter T, Elliott PM, Flather M, Garcia-Pavia P, Haugaa KH, Ingles J, Jurcut RO, Klaassen S, Limongelli G, Loeys B, Mogensen J, Olivotto I, Pantazis A, Sharma S, Van Tintelen JP, Ware JS, Kaski JP; ESC Scientific Document Group. 2023 ESC Guidelines for the management of cardiomyopathies. Eur Heart J. 2023 Oct 1;44(37):3503-3626. doi: 10.1093/eurheartj/ehad194. No abstract available.
- Individual participant dataSharing planned: Yes. After the study is completed, the de-identified, archived data will be stored within REDCap, for use by other researchers including those outside of the study, but only within the University of Arizona. The consent for the study includes information that de-identified data may be used for future unspecified research.
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Recruiting
Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
Ventricular Tachycardia
RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prednisone 40mg in people with Ventricular Arrythmia and Non-ischemic Cardiomyopathy, run by Roderick Tung at 1 site 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 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 27 Jul 2026. 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 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Burden of ventricular arrhythmias (time frame: 12 months (8 weeks and 6 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06635863, which also lists 18 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 27 Jul 2026.