An interventional study of Randomization that determine the time of treatment in Chronic Kidney Disease, sponsored by Centre Hospitalier Universitaire de Nice. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-11.
Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Other
Objective:
To show that the frequency of aldosterone breakthrough is lower when RAS blockers are given at bedtime compared to on awaking, and to analyze the determinants and consequences of aldosterone breakthrough.
Duration of the study: Inclusion 2 years, follow-up one year, total 3 years Design: prospective, multicenter, randomized, controlled, open label, two parallel groups.
Main selection criteria:
Inclusion criteria
Exclusion criteria
Evaluation criteria:
Primary: Serum aldosterone levels at one year.
Secondary:
Rational:
Serum aldosterone levels may increase despite blockade of the renin angiotensin system (RAS) with angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB). This aldosterone breakthrough might be associated with bad outcomes: left ventricular hypertrophy, proteinuria and progression of renal failure. Antihypertensive drugs are given either on awaking or at bedtime. RAS is stimulated during nighttime. RAS blockers and diuretics given on awaking may stimulate aldosterone synthesis, and favor aldosterone breakthrough.
Objective:
To show that the frequency of aldosterone breakthrough is lower when RAS blockers are given at bedtime compared to on awaking, and to analyze the determinants and consequences of aldosterone breakthrough.
Duration of the study: Inclusion 2 years, follow-up one year, total 3 years
Design: prospective, multicenter, randomized, controlled, open label, two parallel groups.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 104 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
patients continue to take their treatments (RAS blockers and diuretics) on awaking
Other: Randomization that determine the time of treatment
Patients take their treatments(RAS blockers and diurectics)at bedtime
Other: Randomization that determine the time of treatment
Also known as: Randomization determine if the treatment will be taken in the morning or in the evening without changing the treatment
Serum aldosterone levels at one year
Time frame: Level change between baseline and one year
Serum aldosterone/renin ratio
Time frame: level change between baseline and 12 months
Significant aldosterone breakthrough Significant aldosterone breakthrough
Significant aldosterone breakthrough defined by a \>10% increase of serum aldosterone levels over baseline values,
Time frame: changes between baseline and one year
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Nice