EARLY treatment with Candesartan vs Placebo in asymptomatic GENEtic carriers of Dilated Cardiomyopathy (EARLY-GENE trial)

Conditions

Genetic carriers of dilated cardiomyopathy causing variants

Brief summary

Proportion of participants that progress to either a LVEF or LVEDV deterioration of ≥10% with respect to the baseline value at the end of follow-up as measured by MRI

Detailed description

Proportion of participants that progress to a LVEF deterioration of ≥10% compared to baseline value at the end of follow-up as measured by MRI, Proportion of participants that progress to a LVEDV deterioration of ≥10% compared to baseline value at the end of follow-up as measured by MRI., Changes in LVEF measured by MRI (vs baseline), Changes in LVEDV measured by MRI (vs baseline), Proportion of individuals who develop DCM (LVEF<50%), Proportion of participants in each treatment group developing Serious Adverse Events (SAEs), Grade 3-4 adverse events (AEs), Adverse Reactions, or AEs of Special Interest (AESIs), Proportion of treatment discontinuations in the candesartan and placebo groups

Related papers

No related papers found yet.

Interventions

DRUGAtacand 8

DRUGtabletten 8 mg

DRUGCandesartán Kern Pharma 8 mg comprimidos EFG

DRUGCandesartan cilexetil Teva 8 mg

DRUGtabletten

DRUGSame composition than TEST PRODUCT (16 mg candesartan) but with no active substance

DRUGCandesartán Kern Pharma 16 mg comprimidos EFG

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Proportion of participants that progress to either a LVEF or LVEDV deterioration of ≥10% with respect to the baseline value at the end of follow-up as measured by MRI	—

Secondary

Measure	Time frame
Proportion of participants that progress to a LVEF deterioration of ≥10% compared to baseline value at the end of follow-up as measured by MRI, Proportion of participants that progress to a LVEDV deterioration of ≥10% compared to baseline value at the end of follow-up as measured by MRI., Changes in LVEF measured by MRI (vs baseline), Changes in LVEDV measured by MRI (vs baseline), Proportion of individuals who develop DCM (LVEF<50%), Proportion of participants in each treatment group developing Serious Adverse Events (SAEs), Grade 3-4 adverse events (AEs), Adverse Reactions, or AEs of Special Interest (AESIs), Proportion of treatment discontinuations in the candesartan and placebo groups	—

Measure

Time frame

Proportion of participants that progress to a LVEF deterioration of ≥10% compared to baseline value at the end of follow-up as measured by MRI, Proportion of participants that progress to a LVEDV deterioration of ≥10% compared to baseline value at the end of follow-up as measured by MRI., Changes in LVEF measured by MRI (vs baseline), Changes in LVEDV measured by MRI (vs baseline), Proportion of individuals who develop DCM (LVEF<50%), Proportion of participants in each treatment group developing Serious Adverse Events (SAEs), Grade 3-4 adverse events (AEs), Adverse Reactions, or AEs of Special Interest (AESIs), Proportion of treatment discontinuations in the candesartan and placebo groups

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Countries

Netherlands, Spain

Outcome results

None listed