RAS Blockade at Bedtime Versus on Awakening for Aldosterone Breakthrough

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-27

Study Completion Date

2018-01-12

Brief Summary

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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

* Chronic kidney disease stage 3 to 4,
* ACEI (captopril, enalapril, or ramipril), and/or ARB (losartan, valsartan, or irbesartan) on awaking for at least three months,
* History of hypertension or proteinuria \> 0,5 g/24h or g/g créatininurie.

Exclusion criteria

* Office blood pressure ≥ 160/100 mmHg,
* Anti-aldosterone (spironolactone, eplerenone) or potassium sparing diuretics (modamide, amiloride), or direct renin inhibitor.

Evaluation criteria:

Primary: Serum aldosterone levels at one year.

Secondary:

* Serum aldosterone/renin ratio,
* 24h urine aldosterone,
* Significant aldosterone breakthrough defined by a \>10% increase of serum aldosterone levels over baseline values,
* Aldosterone breakthrough defined by an increase of serum aldosterone levels over baseline values,
* HbA1c,
* Urinary albumin/creatinine ratio (UACR) on spot morning urine samples,
* Systolic home blood pressure (SBP),
* Estimated glomerular filtration rate (eGFR) using the MDRD equation.

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Detailed Description

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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.

Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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MORNING

patients continue to take their treatments (RAS blockers and diuretics) on awaking

Group Type ACTIVE_COMPARATOR

Randomization that determine the time of treatment

Intervention Type OTHER

EVENING

Patients take their treatments(RAS blockers and diurectics)at bedtime

Group Type EXPERIMENTAL

Randomization that determine the time of treatment

Intervention Type OTHER

Interventions

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Randomization that determine the time of treatment

Intervention Type OTHER

Other Intervention Names

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Randomization determine if the treatment will be taken in the morning or in the evening without changing the treatment

Eligibility Criteria

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Inclusion Criteria

* Chronic kidney disease stage 3 to 4,
* ACEI (captopril, enalapril, or ramipril), and/or ARB (losartan, valsartan, or irbesartan) on awaking for at least three months,
* History of hypertension or proteinuria \> 0,5 g/24h or g/g creatininuria,
* Adult with social security insurance,
* Informed consent signed.

Exclusion Criteria

* Office blood pressure ≥ 160/100 mmHg,
* Pathology with life expectancy \< 1 year,
* Anti-aldosterone (spironolactone, eplerenone) or potassium sparing diuretics (modamide, amiloride), or direct renin inhibitor.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No