ATTR-CM (Transthyretin Amyloid Cardiomyopathy)RV-CAMNCT07784712
Right Ventricular Septal Biopsy to Detect Cardiac Amyloidosis
An observational study of ATTR-CM (Transthyretin Amyloid Cardiomyopathy) and Heart Failure, run by Geisinger Clinic.
Trial summary
People eligible for this study have had the suggestion from their doctor to receive a cardiac pacemaker or defibrillator to treat a cardiac condition as part of their routine care. Read more about this study
- Who is it for?
- Ages 50 to 105 years
- Conditions the study is for
- ATTR-CM (Transthyretin Amyloid Cardiomyopathy), Heart Failure
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Aug 2028
- Phase
- Observational
- 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 50 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are receiving a cardiac device as standard of care in the Geisinger Health System
Who may be able to join
- Age≥65(or 50-64 with hereditary-ATTR risk: family history of ATTR or known TTR variant)
- Patients with an indication for permanent pacemaker or CRT or ICD device
- Patients willing to comply with all study procedures and be available for the duration of the study. And any one of the following:
- Diagnosis of atrial fibrillation or sinus node dysfunction Diagnosis of AV block Heart failure with preserved ejection fraction Heart failure with reduced ejection fraction Evidence for infiltrative cardiomyopathy Unexplained renal insufficiency Peripheral neuropathy Family h/o cardiomyopathy Family h/o peripheral neuropathy Carpal tunnel syndrome, unprovoked tendon rupture Hip or knee arthroplasty Unexplained RV or LV wall thickening on echocardiogram Unexplained, persistent low-level elevation of cardiac troponins Unexplained orthostatic hypotension Discordance between QRS voltage on ECG and wall thickness on echo Black race Spinal stenosis IVS thickness ≥ 1.2cm (by TTE or cardiac MRI)
Who cannot join
- Inability to provide informed consent
- Pregnant
- Enrolled in a concurrent study that may confound the results of this study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Right Ventricular Septal Biopsy to Detect Cardiac Amyloidosis in At-Risk Population: A Prospective Study
People eligible for this study have had the suggestion from their doctor to receive a cardiac pacemaker or defibrillator to treat a cardiac condition as part of their routine care. We are doing this study to understand if obtaining a tissue sample from their body during a device implant may assist in the early diagnosis of Transthyretin Cardiac Amyloidosis (ATTR-CM).
Read the detailed description
The aim of our study is to assess the feasibility of using chest wall fat-pad biopsy and endomyocardial biopsy in early diagnosis of ATTR-CM in at-risk patients undergoing permanent pacemaker implantations.
Specific Objectives:
- To assess the incidence of ATTR-CM in at-risk patients undergoing permanent pacemaker implantation
- To develop a workflow for the diagnosis of ATTR-CM in pacemaker-indicated patients
- To assess the utility of chest wall fat pad biopsy from the pacemaker pocket in the diagnosis of amyloidosis
- To assess the utility of endomyocardial biopsy at the time of pacemaker implant in the diagnosis of ATTR-CM in an at-risk population
The study team will enroll 70 patients who satisfy inclusion and exclusion criteria. The study team will assess the incidence of amyloidosis and the utility of chest wall fat-pad biopsy, endomyocardial biopsy and deep septal biopsy in the diagnosis of amyloidosis.
- Keywords
- cardiac amyloidosis, cardiac device
- Medical subject headings
- Heart Failure, Amyloid Neuropathies, Familial
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac biopsy results
- ATTR-CM positive results of fat-pad biopsy, endomyocardial biopsy, and deep septal biopsy
- Overall percentage of positive results in this high-risk population
Measured: From enrollment to the end of treatment at 15-21 months.
Secondary outcomes (1)
Safety Events
Safety events (i.e., pericardial tamponade)
Measured: From enrollment to the end of treatment at 15-21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for ATTR-CM (Transthyretin Amyloid Cardiomyopathy)Studies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pugazhendhi Vijayaraman, MD, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07784712
- Sponsor's protocol ID
- 2026-0781
- Other IDs
- Clinic Research Fund
- Acronym
- RV-CAM
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study is to assess feasibility of biopsy in a patient population specifically at Geisinger.
Publications
Morishita K, Fujiu K, Yamagata K, Amiya E, Takeda N. Right ventricular myocardial biopsy with a guiding catheter for conduction system pacing during pacemaker implantation revealed transthyretin cardiac amyloidosis. HeartRhythm Case Rep. 2024 Jun 19;10(9):635-638. doi: 10.1016/j.hrcr.2024.06.008. eCollection 2024 Sep. No abstract available.
PubMed 39355814Zhang C, Musikantow DR, Pugliese DN, Mitter SS, Koruth J, Moss N, Mancini DM, Dukkipati SR, Reddy VY, Miller MA. Chest-Wall Adipose Tissue Excisional Biopsy During Pacemaker or Defibrillator Implantation: New Technique to Diagnose Amyloidosis. J Am Coll Cardiol. 2022 Jul 5;80(1):93-94. doi: 10.1016/j.jacc.2022.05.002. No abstract available.
PubMed 35772920Vijayaraman P, Chelu MG, Curila K, Dandamudi G, Herweg B, Mori S, Jastrzebski M, Sharma PS, Shivkumar K, Tung R, Upadhyay G, Vernooy K, Welter-Frost A, Whinnett Z, Zanon F, Ellenbogen KA. Cardiac Conduction System Pacing: A Comprehensive Update. JACC Clin Electrophysiol. 2023 Nov;9(11):2358-2387. doi: 10.1016/j.jacep.2023.06.005. Epub 2023 Aug 16.
PubMed 37589646Chung MK, Patton KK, Lau CP, Dal Forno ARJ, Al-Khatib SM, Arora V, Birgersdotter-Green UM, Cha YM, Chung EH, Cronin EM, Curtis AB, Cygankiewicz I, Dandamudi G, Dubin AM, Ensch DP, Glotzer TV, Gold MR, Goldberger ZD, Gopinathannair R, Gorodeski EZ, Gutierrez A, Guzman JC, Huang W, Imrey PB, Indik JH, Karim S, Karpawich PP, Khaykin Y, Kiehl EL, Kron J, Kutyifa V, Link MS, Marine JE, Mullens W, Park SJ, Parkash R, Patete MF, Pathak RK, Perona CA, Rickard J, Schoenfeld MH, Seow SC, Shen WK, Shoda M, Singh JP, Slotwiner DJ, Sridhar ARM, Srivatsa UN, Stecker EC, Tanawuttiwat T, Tang WHW, Tapias CA, Tracy CM, Upadhyay GA, Varma N, Vernooy K, Vijayaraman P, Worsnick SA, Zareba W, Zeitler EP. 2023 HRS/APHRS/LAHRS guideline on cardiac physiologic pacing for the avoidance and mitigation of heart failure. Heart Rhythm. 2023 Sep;20(9):e17-e91. doi: 10.1016/j.hrthm.2023.03.1538. Epub 2023 May 20.
PubMed 37283271Witteles RM, Bokhari S, Damy T, Elliott PM, Falk RH, Fine NM, Gospodinova M, Obici L, Rapezzi C, Garcia-Pavia P. Screening for Transthyretin Amyloid Cardiomyopathy in Everyday Practice. JACC Heart Fail. 2019 Aug;7(8):709-716. doi: 10.1016/j.jchf.2019.04.010. Epub 2019 Jul 10.
PubMed 31302046Mohammed SF, Mirzoyev SA, Edwards WD, Dogan A, Grogan DR, Dunlay SM, Roger VL, Gertz MA, Dispenzieri A, Zeldenrust SR, Redfield MM. Left ventricular amyloid deposition in patients with heart failure and preserved ejection fraction. JACC Heart Fail. 2014 Apr;2(2):113-22. doi: 10.1016/j.jchf.2013.11.004.
PubMed 24720917Gonzalez-Lopez E, Gallego-Delgado M, Guzzo-Merello G, de Haro-Del Moral FJ, Cobo-Marcos M, Robles C, Bornstein B, Salas C, Lara-Pezzi E, Alonso-Pulpon L, Garcia-Pavia P. Wild-type transthyretin amyloidosis as a cause of heart failure with preserved ejection fraction. Eur Heart J. 2015 Oct 7;36(38):2585-94. doi: 10.1093/eurheartj/ehv338. Epub 2015 Jul 28.
PubMed 26224076Kittleson MM, Maurer MS, Ambardekar AV, Bullock-Palmer RP, Chang PP, Eisen HJ, Nair AP, Nativi-Nicolau J, Ruberg FL; American Heart Association Heart Failure and Transplantation Committee of the Council on Clinical Cardiology. Cardiac Amyloidosis: Evolving Diagnosis and Management: A Scientific Statement From the American Heart Association. Circulation. 2020 Jul 7;142(1):e7-e22. doi: 10.1161/CIR.0000000000000792. Epub 2020 Jun 1.
PubMed 32476490Nguyen FD, Rodriguez M, Krittanawong C, Witteles R, Lenihan DJ. Misconceptions and Facts About Cardiac Amyloidosis. Am J Cardiol. 2021 Dec 1;160:99-105. doi: 10.1016/j.amjcard.2021.08.045. Epub 2021 Oct 3.
PubMed 34610875Hartnett J, Jaber W, Maurer M, Sperry B, Hanna M, Collier P, Patel DR, Wazni OM, Donnellan E. Electrophysiological Manifestations of Cardiac Amyloidosis: JACC: CardioOncology State-of-the-Art Review. JACC CardioOncol. 2021 Oct 19;3(4):506-515. doi: 10.1016/j.jaccao.2021.07.010. eCollection 2021 Oct.
PubMed 34729522Lane T, Fontana M, Martinez-Naharro A, Quarta CC, Whelan CJ, Petrie A, Rowczenio DM, Gilbertson JA, Hutt DF, Rezk T, Strehina SG, Caringal-Galima J, Manwani R, Sharpley FA, Wechalekar AD, Lachmann HJ, Mahmood S, Sachchithanantham S, Drage EPS, Jenner HD, McDonald R, Bertolli O, Calleja A, Hawkins PN, Gillmore JD. Natural History, Quality of Life, and Outcome in Cardiac Transthyretin Amyloidosis. Circulation. 2019 Jul 2;140(1):16-26. doi: 10.1161/CIRCULATIONAHA.118.038169. Epub 2019 May 21.
PubMed 31109193Gillmore JD, Damy T, Fontana M, Hutchinson M, Lachmann HJ, Martinez-Naharro A, Quarta CC, Rezk T, Whelan CJ, Gonzalez-Lopez E, Lane T, Gilbertson JA, Rowczenio D, Petrie A, Hawkins PN. A new staging system for cardiac transthyretin amyloidosis. Eur Heart J. 2018 Aug 7;39(30):2799-2806. doi: 10.1093/eurheartj/ehx589.
PubMed 29048471Grogan M, Scott CG, Kyle RA, Zeldenrust SR, Gertz MA, Lin G, Klarich KW, Miller WL, Maleszewski JJ, Dispenzieri A. Natural History of Wild-Type Transthyretin Cardiac Amyloidosis and Risk Stratification Using a Novel Staging System. J Am Coll Cardiol. 2016 Sep 6;68(10):1014-20. doi: 10.1016/j.jacc.2016.06.033.
PubMed 27585505
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Right Ventricular Septal Biopsy to Detect Cardiac Amyloidosis in At-Risk Population: A Prospective Study
- ClinicalTrials.gov ID
- NCT07784712
- Acronym / sponsor ID
- RV-CAM / 2026-0781
- Keywords
- cardiac amyloidosis, cardiac device
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 25 Aug 2026 (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.
People eligible for this study have had the suggestion from their doctor to receive a cardiac pacemaker or defibrillator to treat a cardiac condition as part of their routine care. We are doing this study to understand if obtaining a tissue sample from their body during a device implant may assist in the early diagnosis of Transthyretin Cardiac Amyloidosis (ATTR-CM).
Detailed description
The aim of our study is to assess the feasibility of using chest wall fat-pad biopsy and endomyocardial biopsy in early diagnosis of ATTR-CM in at-risk patients undergoing permanent pacemaker implantations.
Specific Objectives:
- To assess the incidence of ATTR-CM in at-risk patients undergoing permanent pacemaker implantation
- To develop a workflow for the diagnosis of ATTR-CM in pacemaker-indicated patients
- To assess the utility of chest wall fat pad biopsy from the pacemaker pocket in the diagnosis of amyloidosis
- To assess the utility of endomyocardial biopsy at the time of pacemaker implant in the diagnosis of ATTR-CM in an at-risk population
The study team will enroll 70 patients who satisfy inclusion and exclusion criteria. The study team will assess the incidence of amyloidosis and the utility of chest wall fat-pad biopsy, endomyocardial biopsy and deep septal biopsy in the diagnosis of amyloidosis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are receiving a cardiac device as standard of care in the Geisinger Health System
Key inclusion criteria (4 listed)
- Age≥65(or 50-64 with hereditary-ATTR risk: family history of ATTR or known TTR variant)
- Patients with an indication for permanent pacemaker or CRT or ICD device
- Patients willing to comply with all study procedures and be available for the duration of the study. And any one of the following:
- Diagnosis of atrial fibrillation or sinus node dysfunction Diagnosis of AV block Heart failure with preserved ejection fraction Heart failure with reduced ejection fraction Evidence for infiltrative cardiomyopathy Unexplained renal insufficiency Peripheral neuropathy Family h/o cardiomyopathy Family h/o peripheral neuropathy Carpal tunnel syndrome, unprovoked tendon rupture Hip or knee arthroplasty Unexplained RV or LV wall thickening on echocardiogram Unexplained, persistent low-level elevation of cardiac troponins Unexplained orthostatic hypotension Discordance between QRS voltage on ECG and wall thickness on echo Black race Spinal stenosis IVS thickness ≥ 1.2cm (by TTE or cardiac MRI)
Key exclusion criteria (3 listed)
- Inability to provide informed consent
- Pregnant
- Enrolled in a concurrent study that may confound the results of this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiac biopsy results
Time frame: From enrollment to the end of treatment at 15-21 months.
* ATTR-CM positive results of fat-pad biopsy, endomyocardial biopsy, and deep septal biopsy * Overall percentage of positive results in this high-risk population
1 secondary outcome
Safety Events
Time frame: From enrollment to the end of treatment at 15-21 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 25 Aug 2026.
- Background: PubMed 39355814Morishita K, Fujiu K, Yamagata K, Amiya E, Takeda N. Right ventricular myocardial biopsy with a guiding catheter for conduction system pacing during pacemaker implantation revealed transthyretin cardiac amyloidosis. HeartRhythm Case Rep. 2024 Jun 19;10(9):635-638. doi: 10.1016/j.hrcr.2024.06.008. eCollection 2024 Sep. No abstract available.
- Background: PubMed 35772920Zhang C, Musikantow DR, Pugliese DN, Mitter SS, Koruth J, Moss N, Mancini DM, Dukkipati SR, Reddy VY, Miller MA. Chest-Wall Adipose Tissue Excisional Biopsy During Pacemaker or Defibrillator Implantation: New Technique to Diagnose Amyloidosis. J Am Coll Cardiol. 2022 Jul 5;80(1):93-94. doi: 10.1016/j.jacc.2022.05.002. No abstract available.
- Background: PubMed 37589646Vijayaraman P, Chelu MG, Curila K, Dandamudi G, Herweg B, Mori S, Jastrzebski M, Sharma PS, Shivkumar K, Tung R, Upadhyay G, Vernooy K, Welter-Frost A, Whinnett Z, Zanon F, Ellenbogen KA. Cardiac Conduction System Pacing: A Comprehensive Update. JACC Clin Electrophysiol. 2023 Nov;9(11):2358-2387. doi: 10.1016/j.jacep.2023.06.005. Epub 2023 Aug 16.
- Background: PubMed 37283271Chung MK, Patton KK, Lau CP, Dal Forno ARJ, Al-Khatib SM, Arora V, Birgersdotter-Green UM, Cha YM, Chung EH, Cronin EM, Curtis AB, Cygankiewicz I, Dandamudi G, Dubin AM, Ensch DP, Glotzer TV, Gold MR, Goldberger ZD, Gopinathannair R, Gorodeski EZ, Gutierrez A, Guzman JC, Huang W, Imrey PB, Indik JH, Karim S, Karpawich PP, Khaykin Y, Kiehl EL, Kron J, Kutyifa V, Link MS, Marine JE, Mullens W, Park SJ, Parkash R, Patete MF, Pathak RK, Perona CA, Rickard J, Schoenfeld MH, Seow SC, Shen WK, Shoda M, Singh JP, Slotwiner DJ, Sridhar ARM, Srivatsa UN, Stecker EC, Tanawuttiwat T, Tang WHW, Tapias CA, Tracy CM, Upadhyay GA, Varma N, Vernooy K, Vijayaraman P, Worsnick SA, Zareba W, Zeitler EP. 2023 HRS/APHRS/LAHRS guideline on cardiac physiologic pacing for the avoidance and mitigation of heart failure. Heart Rhythm. 2023 Sep;20(9):e17-e91. doi: 10.1016/j.hrthm.2023.03.1538. Epub 2023 May 20.
- Background: PubMed 31302046Witteles RM, Bokhari S, Damy T, Elliott PM, Falk RH, Fine NM, Gospodinova M, Obici L, Rapezzi C, Garcia-Pavia P. Screening for Transthyretin Amyloid Cardiomyopathy in Everyday Practice. JACC Heart Fail. 2019 Aug;7(8):709-716. doi: 10.1016/j.jchf.2019.04.010. Epub 2019 Jul 10.
- Background: PubMed 24720917Mohammed SF, Mirzoyev SA, Edwards WD, Dogan A, Grogan DR, Dunlay SM, Roger VL, Gertz MA, Dispenzieri A, Zeldenrust SR, Redfield MM. Left ventricular amyloid deposition in patients with heart failure and preserved ejection fraction. JACC Heart Fail. 2014 Apr;2(2):113-22. doi: 10.1016/j.jchf.2013.11.004.
- Background: PubMed 26224076Gonzalez-Lopez E, Gallego-Delgado M, Guzzo-Merello G, de Haro-Del Moral FJ, Cobo-Marcos M, Robles C, Bornstein B, Salas C, Lara-Pezzi E, Alonso-Pulpon L, Garcia-Pavia P. Wild-type transthyretin amyloidosis as a cause of heart failure with preserved ejection fraction. Eur Heart J. 2015 Oct 7;36(38):2585-94. doi: 10.1093/eurheartj/ehv338. Epub 2015 Jul 28.
- Background: PubMed 32476490Kittleson MM, Maurer MS, Ambardekar AV, Bullock-Palmer RP, Chang PP, Eisen HJ, Nair AP, Nativi-Nicolau J, Ruberg FL; American Heart Association Heart Failure and Transplantation Committee of the Council on Clinical Cardiology. Cardiac Amyloidosis: Evolving Diagnosis and Management: A Scientific Statement From the American Heart Association. Circulation. 2020 Jul 7;142(1):e7-e22. doi: 10.1161/CIR.0000000000000792. Epub 2020 Jun 1.
- Background: PubMed 34610875Nguyen FD, Rodriguez M, Krittanawong C, Witteles R, Lenihan DJ. Misconceptions and Facts About Cardiac Amyloidosis. Am J Cardiol. 2021 Dec 1;160:99-105. doi: 10.1016/j.amjcard.2021.08.045. Epub 2021 Oct 3.
- Background: PubMed 34729522Hartnett J, Jaber W, Maurer M, Sperry B, Hanna M, Collier P, Patel DR, Wazni OM, Donnellan E. Electrophysiological Manifestations of Cardiac Amyloidosis: JACC: CardioOncology State-of-the-Art Review. JACC CardioOncol. 2021 Oct 19;3(4):506-515. doi: 10.1016/j.jaccao.2021.07.010. eCollection 2021 Oct.
- Background: PubMed 31109193Lane T, Fontana M, Martinez-Naharro A, Quarta CC, Whelan CJ, Petrie A, Rowczenio DM, Gilbertson JA, Hutt DF, Rezk T, Strehina SG, Caringal-Galima J, Manwani R, Sharpley FA, Wechalekar AD, Lachmann HJ, Mahmood S, Sachchithanantham S, Drage EPS, Jenner HD, McDonald R, Bertolli O, Calleja A, Hawkins PN, Gillmore JD. Natural History, Quality of Life, and Outcome in Cardiac Transthyretin Amyloidosis. Circulation. 2019 Jul 2;140(1):16-26. doi: 10.1161/CIRCULATIONAHA.118.038169. Epub 2019 May 21.
- Background: PubMed 29048471Gillmore JD, Damy T, Fontana M, Hutchinson M, Lachmann HJ, Martinez-Naharro A, Quarta CC, Rezk T, Whelan CJ, Gonzalez-Lopez E, Lane T, Gilbertson JA, Rowczenio D, Petrie A, Hawkins PN. A new staging system for cardiac transthyretin amyloidosis. Eur Heart J. 2018 Aug 7;39(30):2799-2806. doi: 10.1093/eurheartj/ehx589.
- Individual participant dataSharing planned: No. This study is to assess feasibility of biopsy in a patient population specifically at Geisinger.
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Transthyretin Amyloid Cardiomyopathy (ATTR CM)
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.
Pugazhendhi Vijayaraman, MD principal investigator
Geisinger Clinic
Questions about this trial
What is this clinical trial studying?
An observational study of ATTR-CM (Transthyretin Amyloid Cardiomyopathy) and Heart Failure, run by Geisinger Clinic.
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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Grace Hughes, BS, MPH (570-808-3461, gehughes@geisinger.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac biopsy results (time frame: From enrollment to the end of treatment at 15-21 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 NCT07784712, which also lists 13 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 25 Aug 2026.