Letermovir versus valganciclovir to prevent CMV after heart transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, prospective, randomized two-arm study comparing letermovir to valganciclovir as primary CMV prophylaxis in adult heart transplant recipients at moderate-to-high serostatus risk. Participants will be randomized to receive letermovir (with acyclovir for HSV prophylaxis for six months) or valganciclovir and will be followed for CMV viremia, CMV disease, and safety outcomes including leukopenia and neutropenia. Low-risk patients will be monitored observationally to better characterize CMV outcomes in that group. The trial is designed to confirm whether letermovir provides similar protection against CMV with a more favorable blood-count safety profile compared with valganciclovir in the heart transplant population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Patients who are \>18 years of age who have received a heart transplant and have not started their CMV prophylaxis regimen will be included.

Exclusion Criteria:

History of or suspected CMV disease within 6 months prior is excluded.

Where it's running

• NYP-Weill Cornell
  New York, New York, United States Recruiting
• Columbia University/NYP Milstein Hospital
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: Afsana Rahman, MD
• Email: ar3262@cumc.columbia.edu
• Phone: 2123054600

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.