Multicenter Clinical Trial to Evaluate the Efficacy of a Preventive Strategy Against CMV Infection in Heart Transplant Patients, Based on the Specific T Cells Response

NCT04278547 | Unknown Phase 4 DMC

• 1 other identifier: PI19/01610
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the efficacy and safety of an individualized preventive strategy against CMV infection in CMV seropositive heart transplant patients based on the specific basal response of the lymphocytes againts CMV (ELISPOT Interferon-γ assay). In two thirds of the patients a preventive strategy will be carried out based on the result of the ELISPOT IFN-γ assay and in one third of the patients the standard of care strategy will be carried out (universal prophylaxis).

Conditions

Heart Transplant Infection; CMV Infection

Outcome Measures

Primary Outcomes (1)

• Number of patients who have CMV infection in the first year post heart transplant.

  Any viremia

  One year

Secondary Outcomes (20)

• Number of patients with late CMV infection.

  One year

• Number of patients with acute rejection.

  One year

• Number of patients with vascular graft disease.

  One year

• Number of patients with other bacterial or viral opportunistic infections.

  One year

• Number of patients with leukopenia secondary to prophylaxis.

  One year

Study Arms (2)

Experimental group

EXPERIMENTAL

Preventive strategy based on the ELISPOT IFN-γ result: If patients are stratified as high risk they will receive prophylaxis with valgancyclovir for 3 months and if they are stratified as low risk they will be treated with preemptive therapy guided by CMV polymerase chain reaction analysis;

Diagnostic Test: ELISPOT IFN-γ assay

Control group

NO INTERVENTION

Standard of care, universal prophylaxis with valgancyclovir for 3 months).

Interventions

ELISPOT IFN-γ assay DIAGNOSTIC_TEST

ELISPOT IFN-γ diagnostic test: Evaluation of specific cellular immune response against the IE-1 antigen and the CMV pp65, using the technique ELISPOT IFN-γ and individualize the preventive strategy according to the result. In patients with a ELISPOT of "low risk" will be made advance therapy (preemptive therapy) guided by PCR of CMV In patients with a "high risk" ELISPOT, universal prophylaxis with valganciclovir will be performed oral (900 mg / 24h) or intravenous ganciclovir (5-10 mg / Kd / day) in case the oral route is not available.

Also known as: Valganciclovir

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (18 years or more), both sexes, heart transplant patients.
• Patients with positive IgG against CMV (seropositive).
• Informed consent given by the subject or his legal representative.
• Availability of obtaining recipient and donor serologies.
• Availability of obtaining biological samples of peripheral blood post-transplant to be able to perform the ELISPOT IFN-γ assay.
• Women of childbearing age who use effective contraceptive measures during and until, so less, 30 days after treatment. Men who use contraceptive measures of barrier during and for at least 90 days after treatment, unless there is certainty that the female partner does not run the risk of becoming pregnant.

You may not qualify if:

• Pregnancy and / or breastfeeding period.
• Patients with contraindication for the use of valganciclovir or ganciclovir.
• Patients receiving thymoglobulin as induction therapy.

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead
• Instituto de Salud Carlos III: collaborator
• Spanish Society of Cardiology: collaborator

Study Sites (1)

Hospital Universitari de Bellvitge

Barcelona, 08907, Spain

RECRUITING

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• José González Costello

  Cardiologist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose González Costello

CONTACT

+0034 932607686; jgonzalez@bellvitgehospital.cat

Elena García Romero

CONTACT

e.garcia.r@bellvitgehospital.cat

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Elena García Romero

Model Details: Phase IV clinical trial (with authorized treatment), randomized (2:1), controlled, open label and multicentric, with two parallel groups (Experimental group: preventive strategy based on the ELISPOT IFN-γ result: If patients are stratified as high risk they will receive prophylaxis with valgancyclovir for 3 months and if they are stratified as low risk they will be treated with preemptive therapy guided by CMV polymerase chain reaction analysis; Control group: Standard of care, universal prophylaxis with valgancyclovir for 3 months).

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 20, 2020
• Study Start: June 12, 2020
• Primary Completion: March 25, 2022
• Study Completion: March 25, 2023
• Last Updated: December 23, 2020

Record last verified: 2020-12

Locations

ES (1)