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Coronary Artery CalcificationPhase 3NCT03314493

Prevention of the Progression of Coronary Calcification With Use of Spironolactone in Peritoneal Dialysis Patients

A Phase 3 study testing Spironolactone 25Mg Tablet in people with Coronary Artery Calcification and Vascular Calcification, run by Professor Fernando Figueira Integral Medicine Institute at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Spironolactone 25Mg Tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteBrazil
Study dates
7 Nov 2014to 10 Nov 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Instituto de Medicina Integral Prof. Fernando Figueira

    Recife, Pernambuco, 50070-550

Other trials in Brazil

About this study

Official title: Effect of Spironolactone on the Progression of Coronary Calcification in Peritoneal Dialysis Patients

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.

Being tested
Spironolactone 25Mg Tablet
Keywords
Vascular calcification, Coronary calcification, Peritoneal Dialysis, Spironolactone
Medical subject headings
Vascular Calcification

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Spironolactone 25Mg TabletDrug

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

Study groups in NCT03314493
Study groupRoleWhat they receive
Spironolactone groupExperimentalSpironolactone oral tablet 25mg/day, for 12 months
Receives: Drug: Spironolactone 25Mg Tablet
Control groupNo interventionNo spironolactone use

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (6)

  1. Absolute progression of the coronary calcium score

    To evaluate the absolute progression of the coronary calcium score, defined as the difference between the final score and the baseline score. Coronary calcium score detected using multi-detector computed tomography and expressed in Agatston units.

    Measured: 12 months

  2. Adverse effects of spironolactone use

    During follow-up, all patients were assessed monthly to evaluate the frequency of hyperpotassemia (serum potassium > 6mEq/L), hypotension (systolic blood pressure < 100 mmHg) and/or diastolic blood pressure < 60 mmHg) and gynecomastia defined as breast augmentation, painful or not.

    Measured: 12 months

  3. 1 year change in laboratory parameters of mineral metabolism

    Assess changes in serum levels of total calcium, phosphorus, alkaline phosphatase, 25(OH) vitamina D and intact parathyroid hormone, through periodic blood dosages of these parameters, during follow-up.

    Measured: 12 months

  4. Need for spironolactone dose reduction

    In the presence of adverse effects, the dose of spironolactone was reduced from 25 to 12,5 mg per day.

    Measured: 12 months

  5. Causes of discontinuation of the study

    Severe hyperpotassemia defined as serum potassium>7mEq/L; lack of improvement in the adverse effects of spironolactone with a dose reduction of 12,5 mg/day, ie, persistence of breasts enlargement, hypotension and hyperpotassemia (serum potassium < 6mEq/L); discontinuation of peritoneal dialysis due to renal transplantation or the need for hemodialysis transfer; withdrawal of consent at any time; and death were considered as causes for discontinuation of the study. For the evaluation of this outcome, the patients were submitted to medical visit and biochemical measures monthly.

    Measured: 12 months

  6. 1 year change in laboratory parameters related to inflammation.

    Assess changes on serum levels of c-reactive protein, albumin and fetuin-A, through periodic blood dosages of these parameters, during follow-up.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2017
  2. Study start7 Nov 2014
  3. Primary completion10 Nov 2016
  4. Study completion10 Nov 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03314493
Sponsor's protocol ID
U1111-1203-1767
Status last verified
Oct 2017
First submitted
4 Oct 2017
Last updated
19 Oct 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 20719979

  • 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.

    PubMed 23298834

  • 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.

    PubMed 26336165

  • 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.

    PubMed 12935835

  • 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.

    PubMed 24184249

  • 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.

    PubMed 33586138

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Spironolactone 25Mg Tablet in people with Coronary Artery Calcification and Vascular Calcification, run by Professor Fernando Figueira Integral Medicine Institute at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relative progression of the coronary calcium score (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03314493, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2017.

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