NCT03314493

Brief Summary

Vascular calcification is a frequent complication in dialysis patients and is strongly associated with mortality. Its pathogenesis is complex and involves a series of markers that act on the vascular microenvironment. There is evidence that aldosterone is one of the biomarkers and may have a role in osteoinductive pathways.The aim of this study was to evaluate the effect of spironolactone, an inhibitor of mineralocorticoid receptor, in the progression of coronary calcification in patients undergoing peritoneal dialysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2014

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

November 7, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 19, 2017

Completed
Last Updated

October 19, 2017

Status Verified

October 1, 2017

Enrollment Period

2 years

First QC Date

October 4, 2017

Last Update Submit

October 15, 2017

Conditions

Coronary Artery CalcificationVascular Calcification

Keywords

Vascular calcificationCoronary calcificationPeritoneal DialysisSpironolactone

Outcome Measures

Primary Outcomes (1)

  • Relative progression of the coronary calcium score

    Percentage change in coronary calcium score from baseline to end of study. Coronary calcium score detected using multi-detector computed tomography and expressed in Agatston units.

    12 months

Secondary Outcomes (6)

  • Absolute progression of the coronary calcium score

    12 months

  • Adverse effects of spironolactone use

    12 months

  • 1 year change in laboratory parameters of mineral metabolism

    12 months

  • Need for spironolactone dose reduction

    12 months

  • Causes of discontinuation of the study

    12 months

  • +1 more secondary outcomes

Study Arms (2)

Spironolactone group

EXPERIMENTAL

Spironolactone oral tablet 25mg/day, for 12 months

Drug: Spironolactone 25Mg Tablet

Control group

NO INTERVENTION

No spironolactone use

Interventions

Spironolactone 25Mg TabletDRUG

Patients with coronary calcium score \> 30 were treated with spironolactone for 12 months

Spironolactone group

Eligibility Criteria

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

You may qualify if:

  • Coronary calcium score \> 30 Agatston unit
  • Peritoneal dialysis for at least 6 months

You may not qualify if:

  • Use of spironolactone in the last 3 months
  • Mean serum potassium \> 6 mEq/L in the last 3 months
  • Cardiac revascularization surgeries
  • Arrhythmias
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Medicina Integral Prof. Fernando Figueira

Recife, Pernambuco, 50070-550, Brazil

Location

Related Publications (6)

  • Fischer SS, Kempe DS, Leibrock CB, Rexhepaj R, Siraskar B, Boini KM, Ackermann TF, Foller M, Hocher B, Rosenblatt KP, Kuro-O M, Lang F. Hyperaldosteronism in Klotho-deficient mice. Am J Physiol Renal Physiol. 2010 Nov;299(5):F1171-7. doi: 10.1152/ajprenal.00233.2010. Epub 2010 Aug 18.

    PMID: 20719979BACKGROUND

  • Voelkl J, Alesutan I, Leibrock CB, Quintanilla-Martinez L, Kuhn V, Feger M, Mia S, Ahmed MS, Rosenblatt KP, Kuro-O M, Lang F. Spironolactone ameliorates PIT1-dependent vascular osteoinduction in klotho-hypomorphic mice. J Clin Invest. 2013 Feb;123(2):812-22. doi: 10.1172/JCI64093. Epub 2013 Jan 9.

    PMID: 23298834BACKGROUND

  • Tatsumoto N, Yamada S, Tokumoto M, Eriguchi M, Noguchi H, Torisu K, Tsuruya K, Kitazono T. Spironolactone ameliorates arterial medial calcification in uremic rats: the role of mineralocorticoid receptor signaling in vascular calcification. Am J Physiol Renal Physiol. 2015 Dec 1;309(11):F967-79. doi: 10.1152/ajprenal.00669.2014. Epub 2015 Sep 2.

    PMID: 26336165BACKGROUND

  • Nitta K, Akiba T, Nihei H. Aldosterone blockade and vascular calcification in hemodialysis patients. Am J Med. 2003 Aug 15;115(3):250. doi: 10.1016/s0002-9343(03)00293-6. No abstract available.

    PMID: 12935835RESULT

  • Matsumoto Y, Mori Y, Kageyama S, Arihara K, Sugiyama T, Ohmura H, Yakushigawa T, Sugiyama H, Shimada Y, Nojima Y, Shio N. Spironolactone reduces cardiovascular and cerebrovascular morbidity and mortality in hemodialysis patients. J Am Coll Cardiol. 2014 Feb 18;63(6):528-36. doi: 10.1016/j.jacc.2013.09.056. Epub 2013 Oct 30.

    PMID: 24184249RESULT

  • Hasegawa T, Nishiwaki H, Ota E, Levack WM, Noma H. Aldosterone antagonists for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2021 Feb 15;2(2):CD013109. doi: 10.1002/14651858.CD013109.pub2.

    PMID: 33586138DERIVED

MeSH Terms

Conditions

Vascular Calcification

Interventions

SpironolactoneTablets

Condition Hierarchy (Ancestors)

CalcinosisCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsDosage FormsPharmaceutical Preparations

Study Officials

  • Ana Paula S Gueiros, MD

    Instituto de Medicina Integral Prof. Fernando Figueira

    PRINCIPAL INVESTIGATOR

  • Alex SR Souza, PhD

    Instituto de Medicina Integral Prof. Fernando Figueira

    PRINCIPAL INVESTIGATOR

  • Aluizio B Carvalho, PhD

    Universidade Federal de São Paulo

    STUDY DIRECTOR

  • José E Gueiros, MD

    Instituto de Medicina Integral Prof. Fernando Figueira

    STUDY CHAIR

  • Leuridan T Cavalcante, PhD

    Instituto de Medicina Integral Prof. Fernando Figueira

    STUDY CHAIR

  • Dulce E Casarini, PhD

    Universidade Federal de São Paulo

    STUDY CHAIR

  • Marina M Cadena

    Instituto de Medicina Integral Prof. Fernando Figueira

    STUDY CHAIR

  • Karina T Nobrega, MD

    Instituto de Medicina Integral Prof. Fernando Figueira

    STUDY CHAIR

  • Eveline B Calado, MD

    Instituto de Medicina Integral Prof. Fernando Figueira

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 4, 2017

First Posted

October 19, 2017

Study Start

November 7, 2014

Primary Completion

November 10, 2016

Study Completion

November 10, 2016

Last Updated

October 19, 2017

Record last verified: 2017-10

Locations

BR(1)