Cardiac Improvement by Eplerenone Among Patients Under Cyclosporine or Tacrolimus for Kidney Transplantation.

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentral Hospital, Nancy, France

About this trial

The main objective of this research is to evaluate the effect, for 36 weeks, of eplerenone on abnormalities observed on cardiac ultrasound in patients with kidney transplantation for at least one year, under cyclosporine or tacrolimus. The intervention group will receive the usual standard treatment coupled with eplerenone for 36 weeks from randomization, while the control group will only receive the standard treatment. The main hypothesis is that anticalcineurins (cyclosporin or tacrolimus) lead to activation of the MR of vascular smooth muscle cells, vasoconstriction and vascular inflammation, which contributes to the persistence or recurrence of heart abnormalities in these patients after the initial post-transplant phase. The administration of eplerenone could antagonize this hyperactivation, reduce the cardiovascular effects of anticalcineurins and thus ultimately improve the cardiovascular prognosis of transplant patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female with 18 years old or older.

Transplant patient for at least one year.

Patient on long-term cyclosporine or tacrolimus.

Patient whose clinical situation has been stable for at least 3 months, without major treatment modification and without an episode of acute rejection.

Disqualifiers

Kidney transplant recipient more than 5 years post-transplantation.

Patient with permanent atrial fibrillation.

Patient with valvular heart disease (grade ≥ 3).

Patient considered to be at very high risk of mortality within the next year.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Eplerenone

    Drug

    The intervention group will receive standard treatment according to usual care, coupled with eplerenone for 36 weeks from randomization. Start of treatment with eplerenone at the initial dose of 25 mg/day, then adjusted according to clinical and biological tolerance: 12.5 mg/day (i.e., 25 mg/48h), 25 mg/day, and 50 mg/day.

Treatment groups

132 Participants
are divided into 2 treatment groups
Group A: Intervention group (under Eplerenone):Experimental treatment 1 intervention
Group B: Controle group (without eplerenone):No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Hierarchical composite endpoint (win ratio) : 1/ Death or hospitalization for heart failure or acute coronary syndrome, 2/ Variation in indexed left ventricular mass, 3/Variation in indexed left atrial volume.

Time frame
at 36 weeks

Secondary outcomes

1

Evolution of Nt-ProBNP concentration

Time frame
randomization, at 12 and 36 weeks
2

Evolution of collagen biomarkers (PICP )

Time frame
at 36 weeks
3

Evolution of Biological markers of endothelial dysfunction (endothelin)

Time frame
at 36 weeks
4

The occurrence of hyperkalaemia

hyperkalaemia between 5 - 5.49; 5.5 - 6; \>6mmol/L

Time frame
at 36 weeks

Other outcomes

Sponsors and contacts

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