Multicenter clinical trial to evaluate the efficacy of a preventive strategy against CMV infection in heart transplant patients, based on T cells responses.

Phase 1

• Conditions: We will investigate the benefits of monitoring the CMV-specific cellular response using the ELISPOT INF-y technique in patients with a positive serology against CMV, allowing the individualization of the preventión strategy. The drugs valganciclovir and ganciclovir will be used in seropositive patitens (IgG against CMV), not indicated in the data sheet but accepted as part of the habitual prophylaxis of heart transplant patient according to the clinical practice guidelines.; MedDRA version: 20.0 Level: LLT Classification code 10058666 Term: Cytomegalovirus infection reactivation System Organ Class: 100000004862; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2019-002233-11-ES
• Lead Sponsor: Dr. José González Costello.Unidad de Insuficiencia cardíaca avanzada y Trasplante cardíaco. Hospital Univ. Bellvitge

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-02
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 188

Inclusion Criteria

1) Adult patients (18 years or more), both sexes, heart transplant patients.
2) Patients with positive IgG against CMV (seropositive).
3) Informed consent given by the subject or his legal representative.
4) Availability of obtaining recipient and donor serologies.
5) Women of childbearing age who use effective contraceptive methods during and for at least 30 days after treatment. Men who use barrier contraceptive methods during and for at least 90 days after treatment, unless there is certainty that the female partner can’t get pregnant.
6) Availability of obtaining biological samples of peripheral blood post-transplant to be able to perform the ELISPOT IFN-? assay.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 88

Exclusion Criteria

1) Pregnancy and / or lactation.
2) Patients with biological samples in poor condition at visit 2 (at 10 days post-HT) that prevent the determination of immunological tests.
3) Patients receiving thymoglobulin as induction therapy.
4) Patients with contraindication for the use of ganciclovir or valganciclovir.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified