RAS Blockade at Bedtime Versus on Awakening for Aldostero... | NCT01805362

Studies
RAS Blockade at Bedtime Versus on Awakening for Aldosterone Breakthrough

NCT01805362

Sponsor

Centre Hospitalier Universitaire de Nice

Status

Completed

Last Update Posted

Apr 11, 2024Actual

Enrollment

104Actual

Phase

Not Applicable

Conditions

Chronic Kidney Disease

Interventions

Randomization that determine the time of treatment

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 27, 2013Actual

Primary Completion Date

Apr 24, 2014Actual

Completion Date

Jan 12, 2018Actual

First Submitted Date

Feb 28, 2013

First Submission Date that Met QC Criteria

Mar 5, 2013

First Posted Date

Mar 6, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2024

Last Update Posted Date

Apr 11, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

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:

Duration of the study: Inclusion 2 years, follow-up one year, total 3 years

Design: prospective, multicenter, randomized, controlled, open label, two parallel groups.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

104Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MORNING	Active Comparator	patients continue to take their treatments (RAS blockers and diuretics) on awaking	Other: Randomization that determine the time of treatment
EVENING	Experimental	Patients take their treatments(RAS blockers and diurectics)at bedtime	Other: Randomization that determine the time of treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Randomization that determine the time of treatment	Other		EVENING MORNING	Randomization determine if the treatment will be taken in the morning or in the evening without changing the treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serum aldosterone levels at one year		Level change between baseline and one year

Secondary Outcomes

Measure	Description	Time Frame
Serum aldosterone/renin ratio		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,

Other Outcomes

Not provided

Eligibility Module

Eligibility 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 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vincent ESNAULT, MD	Nice University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Nephrology, Nice University Hospital		Nice		06000	France

Condition Browse Module

MeSH Terms

ID	Term
D051436	Renal Insufficiency, Chronic

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided