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Trial · NCT01857856

PHOspholamban RElated CArdiomyopathy STudy - Intervention

NCT01857856, Phase 3, Completed, M.p. van den Berg, MD, PhD, professor in Cardiology

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. PHOspholamban RElated CArdiomyopathy STudy - Intervention. Trials, record NCT01857856. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01857856

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
PHOspholamban RElated CArdiomyopathy STudy - Intervention
NCT number
NCT01857856
Status
Completed
Phases
Phase 3
Enrollment
84 participants, actual
Lead sponsor
M.p. van den Berg, MD, PhD, professor in Cardiology
Conditions
Phospholamban R14del Mutation-related Cardiomyopathy
Interventions
Eplerenone
First posted
2013-05-20
Last updated
2021-10-18
Other registries' IDs
eudract:2013-001067-23

Source ClinicalTrials.gov

Registered outcomes19

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryLeft ventricular (LV) enddiastolic volume, increase >10%, as measured by MRIthree years
PrimaryLV ejection fraction, absolute decrease >5%, as measured by MRIthree years
PrimaryRight ventricular (RV) enddiastolic volume, increase >10%, as measured by MRIthree years
PrimaryRV ejection fraction, absolute decrease >5%, as measured by MRIthree years
Primarylate gadolinium enhancement, absolute increase >5%, as measured by MRIthree years
PrimaryChange in ventricular premature complexes, increase >100% in combination with absolute number >1000/24 hrs (Holter monitoring)yearly at 0, 1, 2 and 3 years
PrimaryChange in the occurrence of non-sustained ventricular tachycardia (Holter monitoring, exercise testing)yearly at 0, 1, 2 and 3 years
PrimaryChange in QRS voltage, decrease >25% (ECG)yearly at 0,1,2 and 3 years
PrimaryChange in symptoms/signs of heart failure and/or arrhythmias necessitating treatment according to the attending physician and likely due to arrhythmogenic cardiomyopathyyearly at 0,1,2 and 3 years, and possibly in between at referral
Primary(Change in) cardiovascular death, including sudden death, likely due to arrhythmogenic cardiomyopathyyearly at 0,1,2 and 3 years, and possibly in between at referral

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers7

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
22820313BACKGROUNDPubMed
24909667BACKGROUNDPubMed
26970417BACKGROUNDPubMed
28759816BACKGROUNDPubMed
29635323BACKGROUNDPubMed
30763825BACKGROUNDPubMed
34143416DERIVEDPubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01857856

GET https://conductscience.org/api/trials/v1/NCT01857856/registered