Valganciclovir vs. Letermovir for CMV Prophylaxis in Heart Transplant
NCT ID: NCT07079735
Last Updated: 2025-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
150 participants
INTERVENTIONAL
2025-09-12
2029-01-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Letermovir
Patients with moderate to high risk CMV risk will get letermovir for prophylaxis for 6 months for moderate risk and 1 year for high risk
Letermovir
CMV prophylaxis
Valganciclovir
Patients with moderate to high risk CMV risk will get valganciclovir for prophylaxis for 6 months for moderate risk and 1 year for high risk. This is standard of care
Valganciclovir
Standard therapy for CMV prophylaxis
No treatment
Low risk CMV patients who do not have an indication for CMV prophylaxis will be monitored
No interventions assigned to this group
Interventions
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Letermovir
CMV prophylaxis
Valganciclovir
Standard therapy for CMV prophylaxis
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
99 Years
ALL
No
Sponsors
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Cornell University
OTHER
Columbia University
OTHER
Responsible Party
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Afsana Rahman
Assistant Professor of Medicine
Locations
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NYP-Weill Cornell
New York, New York, United States
Columbia University/NYP Milstein Hospital
New York, New York, United States
Countries
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Central Contacts
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Adel T Alnatour, BS
Role: CONTACT
Facility Contacts
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Adel T Alnatour, BS
Role: backup
Adel T Alnatour, BS
Role: backup
References
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Limaye AP, Budde K, Humar A, Vincenti F, Kuypers DRJ, Carroll RP, Stauffer N, Murata Y, Strizki JM, Teal VL, Gilbert CL, Haber BA. Letermovir vs Valganciclovir for Prophylaxis of Cytomegalovirus in High-Risk Kidney Transplant Recipients: A Randomized Clinical Trial. JAMA. 2023 Jul 3;330(1):33-42. doi: 10.1001/jama.2023.9106.
Chong PP, Teiber D, Prokesch BC, Arasaratnam RJ, Peltz M, Drazner MH, Garg S. Letermovir successfully used for secondary prophylaxis in a heart transplant recipient with ganciclovir-resistant cytomegalovirus syndrome (UL97 mutation). Transpl Infect Dis. 2018 Oct;20(5):e12965. doi: 10.1111/tid.12965. Epub 2018 Jul 20.
Saullo JL, Miller RA. Cytomegalovirus Therapy: Role of Letermovir in Prophylaxis and Treatment in Transplant Recipients. Annu Rev Med. 2023 Jan 27;74:89-105. doi: 10.1146/annurev-med-042921-124739. Epub 2022 Nov 4.
Potena L, Solidoro P, Patrucco F, Borgese L. Treatment and prevention of cytomegalovirus infection in heart and lung transplantation: an update. Expert Opin Pharmacother. 2016 Aug;17(12):1611-22. doi: 10.1080/14656566.2016.1199684. Epub 2016 Jun 30.
Saullo JL, Baker AW, Snyder LD, Reynolds JM, Zaffiri L, Eichenberger EM, Ferrari A, Steinbrink JM, Maziarz EK, Bacchus M, Berry H, Kakoullis SA, Wolfe CR. Cytomegalovirus prevention in thoracic organ transplantation: A single-center evaluation of letermovir prophylaxis. J Heart Lung Transplant. 2022 Apr;41(4):508-515. doi: 10.1016/j.healun.2021.12.005. Epub 2021 Dec 22.
Rahman A, Lee C, Rahman S, Baranowska J, Moeller CM, Valledor AF, Rubenstein G, Oren D, Alnatour AT, Labarre B, Taek K, Bae D, Raikhelkar J, Lotan D, Defilippis EM, Yunis AA, Fried J, Latif F, Yuzefpolskaya M, Colombo PC, Lin E, Majure DT, Clerkin KJ, Choe J, Sayer G, Uriel N. Efficacy of Letermovir for Cytomegalovirus Prophylaxis in Heart Transplant Recipients with Moderate to High-Risk CMV Serostatus. J Card Fail. 2025 Jun 23:S1071-9164(25)00284-2. doi: 10.1016/j.cardfail.2025.05.017. Online ahead of print.
Other Identifiers
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AAAV8422
Identifier Type: -
Identifier Source: org_study_id
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