NCT03329443

Brief Summary

an interventional study to measure the possible effects of spironolactone ( an aldosterone antagonist) on the incidence of acute kidney injury after coronary angiography

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
490

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2017

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2018

Completed
Last Updated

September 10, 2018

Status Verified

September 1, 2018

Enrollment Period

1 year

First QC Date

October 30, 2017

Last Update Submit

September 6, 2018

Conditions

Acute Kidney InjuryIHDContrast-induced Nephropathy

Keywords

spironolactone

Outcome Measures

Primary Outcomes (1)

  • Acute kidney injury by K-DIGO guidelines

    an absolute elevation of serum creatinine of 0.5mg/dl or 25% above baseline

    48-72 hrs

Secondary Outcomes (1)

  • acute kidney injury by NGAL

    6 hours

Other Outcomes (1)

  • safety outcome: serum potassium

    6 hrs

Study Arms (2)

placebo

PLACEBO COMPARATOR
Drug: Placebo Oral Tablet

Spironolactone

ACTIVE COMPARATOR
Drug: Spironolactone

Interventions

SpironolactoneDRUG

each patient will receive 200 mg of spironolactone as per his/her angiography premedications

Also known as: Active group
Spironolactone
Placebo Oral TabletDRUG

Each patient will receive a placebo tablet as per his/her angiography premedications

Also known as: Control group
placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients admitted to angiography unit
  • over 18
  • informed consent

You may not qualify if:

  • acute renal failure before 7 days
  • spironolactone contraindications
  • hyperkalemia (S.K. \>5.5 mEq/L)
  • documented tumor
  • actively taking NSAIDs, Ciclosporin, Cisplatin,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Sader Teaching Hospital

Basra, 00964, Iraq

Location

Related Publications (1)

  • Mujtaba A, Taher MA, Hazza MA, Al-Rubaye HM, Kata AH, AbdulWahab H, AbdulBari A, AlRubay HK. The Effect of Spironolactone on the Incidence of Contrast-Induced Nephropathy in Patients Undergoing Cardiac Catheterization: Study Design and Rationale. Cardiol Ther. 2018 Jun;7(1):101-106. doi: 10.1007/s40119-018-0112-3. Epub 2018 May 21.

    PMID: 29785539DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

SpironolactoneControl Groups

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Alhasan Mujtaba, BCPS

    Baghdad University/College of Pharmacy/Department of Clinical Pharmacy

    PRINCIPAL INVESTIGATOR

  • Mohammed A Taher, Ph.D.

    Baghdad University/College of Pharmacy/Department of Biochemistry

    STUDY CHAIR

  • Mazin A Hazzaa', Ph.D.

    Al-Sader teaching Hospital/Basra Cardiac Center/M.D. Cardiologist

    STUDY DIRECTOR

  • Hassan M Al Rubaye, Ph.D

    Al-Sader teaching Hospital/Basra Cardiac Center/M.D. Cardiologist

    STUDY DIRECTOR

  • Assad H Kata, Ph.D

    Al-Sader teaching Hospital/Basra Cardiac Center/M.D. Cardiologist

    STUDY DIRECTOR

  • Hayder K Abdullkreem, M.Sc

    Head of the clinical laboratory department/ Al-Sader teaching hopital

    STUDY DIRECTOR

  • Hamid A Abdulsada, Ph.D

    Al-Sader teaching Hospital/Basra Cardiac Center/M.D. Cardiologist

    STUDY DIRECTOR

  • Abdul Ameer A Abdul Hameed, PH.D

    Al-Sader teaching Hospital/Basra Cardiac Center/M.D. Cardiologist

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical pharmacy specialist

Study Record Dates

First Submitted

October 30, 2017

First Posted

November 6, 2017

Study Start

September 1, 2017

Primary Completion

September 1, 2018

Study Completion

September 4, 2018

Last Updated

September 10, 2018

Record last verified: 2018-09

Locations

IR(1)