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

The proposed study is a phase IV, randomized, controlled, multicenter and open clinical trial, with two parallel groups, to evaluate the effectiveness of a preventive strategy against CMV infection in heart transplant patients with positive serology against CMV based on T cells responses to IE-1 and pp65 CMV antigens, determined by ELISPOT IFN-? assay - ELISPOT-TC

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-002233-11-ES

Enrollment

188

Registered

2019-12-02

Start date

2020-01-16

Completion date

Unknown

Last updated

2020-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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.

Interventions

Trade Name: Valganciclovir Product Name: Valganciclovir Pharmaceutical Form: Capsule INN or Proposed INN: VALGANCICLOVIR CAS Number: 175

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Primary end point(s): Number of patients who develop CMV infection in the first year post-HT.;Timepoint(s) of evaluation of this end point: During the first year post heart transplantation;Main Objective: To evaluate and compare the incidence of CMV infection in heart transplant patients with CMV IgG positive during the first year post-transplant, in both study groups.;Secondary Objective: TO COMPARE THE INCIDENCE OF:1)CMV disease during the first year post-HT btw both tx gr.2)Infection and CMV disease btw both gr.and stratify them according to the serological combination(IgG)btw donor and recipient.3)Late CMV infection after receiving universal PPx based on cellular immunity against CMV when stopping anti-viral prophylaxis.TO EVALUATE THE:4)Evolution of cellular immune response against CMV in the first 6 months post-HT.5)Association btw cellular immunity and rejection,mortality,other infections and graft vasculopathy6)To evaluate Bcell responses and CMV-specific IgG titer as additional risk biomarkers.7)To evaluate gammaglobulins titer as additional risk biomarkers.8)To compare the economic cost of the 2strategies.9)Incidence of opportunistic infections in patients with leukopenia derived from prophylaxis.10)Impact of donor specific and CMV-specific Tcell responses on graft histology.11)Incidence of:AE with prophylaxis;leukopenia and neutropenia derived from prophylaxis	—

Measure

Time frame

Primary end point(s): Number of patients who develop CMV infection in the first year post-HT.;Timepoint(s) of evaluation of this end point: During the first year post heart transplantation;Main Objective: To evaluate and compare the incidence of CMV infection in heart transplant patients with CMV IgG positive during the first year post-transplant, in both study groups.;Secondary Objective: TO COMPARE THE INCIDENCE OF:1)CMV disease during the first year post-HT btw both tx gr.2)Infection and CMV disease btw both gr.and stratify them according to the serological combination(IgG)btw donor and recipient.3)Late CMV infection after receiving universal PPx based on cellular immunity against CMV when stopping anti-viral prophylaxis.TO EVALUATE THE:4)Evolution of cellular immune response against CMV in the first 6 months post-HT.5)Association btw cellular immunity and rejection,mortality,other infections and graft vasculopathy6)To evaluate Bcell responses and CMV-specific IgG titer as additional risk biomarkers.7)To evaluate gammaglobulins titer as additional risk biomarkers.8)To compare the economic cost of the 2strategies.9)Incidence of opportunistic infections in patients with leukopenia derived from prophylaxis.10)Impact of donor specific and CMV-specific Tcell responses on graft histology.11)Incidence of:AE with prophylaxis;leukopenia and neutropenia derived from prophylaxis

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: During the first year post heart transplantation; Secondary end point(s): 1) Clinical: 1.1.)Number of patients with CMV disease (viral syndrome or invasive tissue disease) in the first year post-transplant. 1.2) Number of patients who have late CMV infection among patients receiving prophylaxis with valganciclovir or ganciclovir (group 1 a and control group), once the treatment is finished. 2.Comorbidities of heart transplant patients: - 2.1) Number of patients with acute rejection - 2.2) Number of patients with vascular graft disease - 2.3) Number of patients with other opportunistic bacterial or viral infections - 2.4) Number of patients with leukopenia secondary to prophylaxis - 2.5) Number of patients with neutropenia secondary to prophylaxis. - 2.6) Number of patients with leukopenia who present others bacterial or viral infections – 3) Mortality: 3.1) Number of patients deceased during hospital admission post-HT. 3.2) Number of deceased patients, related to CMV infection, in the first year post-transplant. 3.3) Number of deceased patients, related to CMV disease, in the first year post-transplant. 3.4) Number of patients deceased due to any cause in the first year post-HT. 4) Immunology: 4.1) Titer of specific IgG antibodies against CMV in serum. 4.2) Nonspecific serum gammaglobulins titer 4.3) Number of patients whose ELISPOT varies from low risk to intermediate or high risk. 4.4) Number of patients whose ELISPOT varies from intermediate or high risk to low risk. 4.5) Number of patients whose ELISPOT varies form intermediate or high risk to low risk 4.6) Number of	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: During the first year post heart transplantation; Secondary end point(s): 1) Clinical: 1.1.)Number of patients with CMV disease (viral syndrome or invasive tissue disease) in the first year post-transplant. 1.2) Number of patients who have late CMV infection among patients receiving prophylaxis with valganciclovir or ganciclovir (group 1 a and control group), once the treatment is finished. 2.Comorbidities of heart transplant patients: - 2.1) Number of patients with acute rejection - 2.2) Number of patients with vascular graft disease - 2.3) Number of patients with other opportunistic bacterial or viral infections - 2.4) Number of patients with leukopenia secondary to prophylaxis - 2.5) Number of patients with neutropenia secondary to prophylaxis. - 2.6) Number of patients with leukopenia who present others bacterial or viral infections – 3) Mortality: 3.1) Number of patients deceased during hospital admission post-HT. 3.2) Number of deceased patients, related to CMV infection, in the first year post-transplant. 3.3) Number of deceased patients, related to CMV disease, in the first year post-transplant. 3.4) Number of patients deceased due to any cause in the first year post-HT. 4) Immunology: 4.1) Titer of specific IgG antibodies against CMV in serum. 4.2) Nonspecific serum gammaglobulins titer 4.3) Number of patients whose ELISPOT varies from low risk to intermediate or high risk. 4.4) Number of patients whose ELISPOT varies from intermediate or high risk to low risk. 4.5) Number of patients whose ELISPOT varies form intermediate or high risk to low risk 4.6) Number of

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Countries

Spain

Contacts

Public ContactHospital Universitari de Bellvitge

Dra. Elena García Romero.Unidad de Insuficiencia cardíaca avanzada y Trasplante cardíaco

garciaromero.elena@gmail.com34932607625

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026