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RAS Blockade at Bedtime Versus on Awakening for Aldosterone Breakthrough

NCT01805362 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2024-04-11

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Randomization that determine the time of treatment

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nice

    lead OTHER

Principal Investigators

  • Vincent ESNAULT, MD · Nice University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-27
Primary Completion
2014-04-24
Completion
2018-01-12

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01805362 on ClinicalTrials.gov