Skip to main content
OpenTrials
Completed

NCT Number: NCT01805362

RAS Blockade at Bedtime Versus on Awakening for 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.

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nephrology, Nice University Hospital

Nice, 06000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Randomization that determine the time of treatment

Other

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

Primary outcomes

  1. Serum aldosterone levels at one year

    Time frame: Level change between baseline and one year

Secondary outcomes

  1. Serum aldosterone/renin ratio

    Time frame: level change between baseline and 12 months

  2. Significant aldosterone breakthrough Significant aldosterone breakthrough

    Time frame: changes between baseline and one year

    Significant aldosterone breakthrough defined by a >10% increase of serum aldosterone levels over baseline values,

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

RAS Blockade at Bedtime Versus on Awakening for the Prevention of Aldosterone Breakthrough

Acronym: IRAB2

Important dates

Study start
2013
Primary completion
2014
Study completion
2018
First posted
Mar 6, 2013
Registry last updated
Apr 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.