PHOspholamban RElated CArdiomyopathy STudy - Intervention
NCT ID: NCT01857856
Last Updated: 2021-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
84 participants
INTERVENTIONAL
2013-05-31
2021-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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No treatment
no medical treatment
No interventions assigned to this group
Eplerenone
Eplerenone (Inspra, 50 mg for 3 years once daily) oral, film-coated tablet 50 mg for 3 years once daily
Eplerenone
eplerenone (inspra; pfizer) one tablet (50mg standard dosis; 25mg reduced dosis) per day
Interventions
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Eplerenone
eplerenone (inspra; pfizer) one tablet (50mg standard dosis; 25mg reduced dosis) per day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age ≥30 and ≤ 65 years
* New York Heart Association functional class ≤ 1
* LV ejection fraction ≥.45 (measured with MRI)
Exclusion Criteria
* A diagnosis of DCM (see appendix 1). Note: regional LV wall motions abnormalities are acceptable.
* A diagnosis of ARVC (according to the task force criteria, see appendix 2)
* Global or regional RV dysfunction and/or structural alterations (according to task force criterion 1, see appendix 2).
* Ventricular premature complexes \>1000 during 24hours Holter-monitoring
* Non-sustained ventricular tachycardia during Holter-monitoring or exercise-testing
* History of sustained ventricular tachycardia or ventricular fibrillation
* Hypertension requiring the use of antihypertensive drugs, or when this is anticipated within the coming 3 years
* Evidence of ischemic heart disease
* Treatment with cardioactive medication
* Hyperkaliemia (serum potassium \>5.0 mmol/l)
* Severe renal dysfunction (eGFR \<30 ml/min/1.73 m2)
* Severe hepatic impairment (Child-Pugh class C)
* Women who are currently pregnant or report a recent pregnancy (last 60 days) or plan on becoming pregnant.
* Concomitant use of CYP3A4-inhibitors (see appendix 5)
* Concomitant use of NSAIDs (see appendix 5)
* Concomitant use of potassium sparing-agents (see appendix 5)
* Known intolerance or contraindication to aldosterone antagonists
* Participation in another drug trial in which the last dose of drug was within the past 30 days.
* Contra-indications for MRI (claustrophobia, metal devices)
* Subjects unable or unwilling to provide written informed consent
30 Years
65 Years
ALL
No
Sponsors
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University Medical Center Groningen
OTHER
The Interuniversity Cardiology Institute of the Netherlands
OTHER_GOV
ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Netherlands: CVON, CardioVascular Research Netherlands
UNKNOWN
M.p. van den Berg, MD, PhD, professor in Cardiology
OTHER
Responsible Party
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M.p. van den Berg, MD, PhD, professor in Cardiology
MD PhD
Principal Investigators
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Maarten van den Berg, MD PhD
Role: PRINCIPAL_INVESTIGATOR
UMCG, Department of Cardiology
Locations
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AMC
Amsterdam, North Holland, Netherlands
Antonius ziekenhuis Sneek
Sneek, Provincie Friesland, Netherlands
UMCG
Groningen, , Netherlands
UMCU
Utrecht, , Netherlands
Countries
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References
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van der Zwaag PA, van Rijsingen IA, Asimaki A, Jongbloed JD, van Veldhuisen DJ, Wiesfeld AC, Cox MG, van Lochem LT, de Boer RA, Hofstra RM, Christiaans I, van Spaendonck-Zwarts KY, Lekanne dit Deprez RH, Judge DP, Calkins H, Suurmeijer AJ, Hauer RN, Saffitz JE, Wilde AA, van den Berg MP, van Tintelen JP. Phospholamban R14del mutation in patients diagnosed with dilated cardiomyopathy or arrhythmogenic right ventricular cardiomyopathy: evidence supporting the concept of arrhythmogenic cardiomyopathy. Eur J Heart Fail. 2012 Nov;14(11):1199-207. doi: 10.1093/eurjhf/hfs119. Epub 2012 Jul 20.
van Rijsingen IA, van der Zwaag PA, Groeneweg JA, Nannenberg EA, Jongbloed JD, Zwinderman AH, Pinto YM, Dit Deprez RH, Post JG, Tan HL, de Boer RA, Hauer RN, Christiaans I, van den Berg MP, van Tintelen JP, Wilde AA. Outcome in phospholamban R14del carriers: results of a large multicentre cohort study. Circ Cardiovasc Genet. 2014 Aug;7(4):455-65. doi: 10.1161/CIRCGENETICS.113.000374. Epub 2014 Jun 8.
Te Rijdt WP, Ten Sande JN, Gorter TM, van der Zwaag PA, van Rijsingen IA, Boekholdt SM, van Tintelen JP, van Haelst PL, Planken RN, de Boer RA, Suurmeijer AJH, van Veldhuisen DJ, Wilde AAM, Willems TP, van Dessel PFHM, van den Berg MP. Myocardial fibrosis as an early feature in phospholamban p.Arg14del mutation carriers: phenotypic insights from cardiovascular magnetic resonance imaging. Eur Heart J Cardiovasc Imaging. 2019 Jan 1;20(1):92-100. doi: 10.1093/ehjci/jey047.
Te Rijdt WP, van Tintelen JP, Vink A, van der Wal AC, de Boer RA, van den Berg MP, Suurmeijer AJ. Phospholamban p.Arg14del cardiomyopathy is characterized by phospholamban aggregates, aggresomes, and autophagic degradation. Histopathology. 2016 Oct;69(4):542-50. doi: 10.1111/his.12963. Epub 2016 May 12.
Te Rijdt WP, van der Klooster ZJ, Hoorntje ET, Jongbloed JDH, van der Zwaag PA, Asselbergs FW, Dooijes D, de Boer RA, van Tintelen JP, van den Berg MP, Vink A, Suurmeijer AJH. Phospholamban immunostaining is a highly sensitive and specific method for diagnosing phospholamban p.Arg14del cardiomyopathy. Cardiovasc Pathol. 2017 Sep-Oct;30:23-26. doi: 10.1016/j.carpath.2017.05.004. Epub 2017 May 30.
Te Rijdt WP, Asimaki A, Jongbloed JDH, Hoorntje ET, Lazzarini E, van der Zwaag PA, de Boer RA, van Tintelen JP, Saffitz JE, van den Berg MP, Suurmeijer AJH. Distinct molecular signature of phospholamban p.Arg14del arrhythmogenic cardiomyopathy. Cardiovasc Pathol. 2019 May-Jun;40:2-6. doi: 10.1016/j.carpath.2018.12.006. Epub 2018 Dec 21.
Te Rijdt WP, Hoorntje ET, de Brouwer R, Oomen A, Amin A, van der Heijden JF, Karper JC, Westenbrink BD, Sillje HHW, Te Riele ASJM, Wiesfeld ACP, van Gelder IC, Willems TP, van der Zwaag PA, van Tintelen JP, Hillege JH, Tan HL, van Veldhuisen DJ, Asselbergs FW, de Boer RA, Wilde AAM, van den Berg MP. Rationale and design of the PHOspholamban RElated CArdiomyopathy intervention STudy (i-PHORECAST). Neth Heart J. 2022 Feb;30(2):84-95. doi: 10.1007/s12471-021-01584-5. Epub 2021 Jun 18.
Other Identifiers
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2013-001067-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
TCC2012007
Identifier Type: -
Identifier Source: org_study_id