NCT02989480

Brief Summary

Arrhythmogenic right ventricular cardiomyopathy (ARVC) is a rare condition in which the heart muscle cells especially of the main pumping chamber (the 'ventricle') is replaced by fat and scar tissue. Sarcoidosis is a condition that can affect many organs but when it affects the heart patches of inflammation can result in scarring, especially of the ventricles. Both conditions can cause dangerous heart rhythms and sudden death. Sarcoidosis can be treated with inflammation suppressing treatment (steroids), as well as pacemakers and implantable defibrillators which shock the heart back to normal rhythm. ARVC is usually treated with implantable defibrillators. The diagnosis of either condition can be difficult and indeed distinguishing the two can be extremely challenging. Increasingly nuclear scans (PET) are used to identify inflammation in the heart in patients suspected of having cardiac sarcoid. It is not known whether patients with ARVC have abnormal PET scans.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2016

Completed
11 months until next milestone

First Posted

Study publicly available on registry

December 12, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

October 11, 2018

Status Verified

October 1, 2018

Enrollment Period

3.9 years

First QC Date

January 20, 2016

Last Update Submit

October 10, 2018

Conditions

SarcoidosisArrhythmogenic Right Ventricular Cardiomyopathy

Keywords

Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

  • Myocardial inflammation or fibrosis by cardiac MRI and PET CT

    Cardiac MRI and PET CT

    Three hours

Study Arms (2)

Sarcoidosis

Patients with cardiac sarcoidosis diagnosed according to the Japanese Ministry of Health and Welfare criteria will be included. All patients will have histologically proven sarcoidosis (cardiac biopsy not mandatory) and no other potential cardiac disease. They will have no family history of cardiomyopathy.

Radiation: PET CTOther: Cardiac MRI

Arrhythmogenic RV cardiomyopathy

Patients with ARVC diagnosed according to the Task Force criteria with in addition either a positive family history for the condition or harbour a known pathological mutation associated with it.

Radiation: PET CTOther: Cardiac MRI

Interventions

PET CTRADIATION

PET CT scans

Arrhythmogenic RV cardiomyopathySarcoidosis
Cardiac MRIOTHER

Cardiac MRI

Arrhythmogenic RV cardiomyopathySarcoidosis

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Twenty patients from the age of 18-70 will be studied. We will include 10 patients with cardiac sarcoidosis diagnosed according to the Japanese Ministry of Health and Welfare criteria. All patients will have histologically proven sarcoidosis (cardiac biopsy not mandatory) and no other potential cardiac disease. They will have no family history of cardiomyopathy. We will also study 10 patients with ARVC diagnosed according to the Task Force criteria with in addition either a positive family history for the condition or harbour a known pathological mutation associated with it.

You may qualify if:

  • Twenty patients from the age of 18-70 will be studied. We will include 10 patients with cardiac sarcoidosis diagnosed according to the Japanese Ministry of Health and Welfare criteria. All patients will have histologically proven sarcoidosis (cardiac biopsy not mandatory) and no other potential cardiac disease. They will have no family history of cardiomyopathy. We will also study 10 patients with ARVC diagnosed according to the Task Force criteria with in addition either a positive family history for the condition or harbour a known pathological mutation associated with it.

You may not qualify if:

  • unwillingness to participate
  • patients with any contraindication to MR scanning
  • pregnant or breast feeding women
  • diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aberdeen Royal Infirmary

Aberdeen, Aberdeenshire, AB25 2ZD, United Kingdom

RECRUITING

Related Publications (10)

  • Marcus FI, McKenna WJ, Sherrill D, Basso C, Bauce B, Bluemke DA, Calkins H, Corrado D, Cox MG, Daubert JP, Fontaine G, Gear K, Hauer R, Nava A, Picard MH, Protonotarios N, Saffitz JE, Sanborn DM, Steinberg JS, Tandri H, Thiene G, Towbin JA, Tsatsopoulou A, Wichter T, Zareba W. Diagnosis of arrhythmogenic right ventricular cardiomyopathy/dysplasia: proposed modification of the task force criteria. Circulation. 2010 Apr 6;121(13):1533-41. doi: 10.1161/CIRCULATIONAHA.108.840827. Epub 2010 Feb 19.

    PMID: 20172911BACKGROUND

  • Dempsey OJ, Paterson EW, Kerr KM, Denison AR. Sarcoidosis. BMJ. 2009 Aug 28;339:b3206. doi: 10.1136/bmj.b3206. No abstract available.

    PMID: 19717499BACKGROUND

  • Mohsen A, Panday M, Wetherold S, Jimenez A. Cardiac sarcoidosis mimicking arrhythmogenic right ventricular dysplasia with high defibrillation threshold requiring subcutaneous shocking coil implantation. Heart Lung Circ. 2012 Jan;21(1):46-9. doi: 10.1016/j.hlc.2011.08.013. Epub 2011 Oct 6.

    PMID: 21982156BACKGROUND

  • Sen-Chowdhry S, Morgan RD, Chambers JC, McKenna WJ. Arrhythmogenic cardiomyopathy: etiology, diagnosis, and treatment. Annu Rev Med. 2010;61:233-53. doi: 10.1146/annurev.med.052208.130419.

    PMID: 20059337BACKGROUND

  • Patel MR, Cawley PJ, Heitner JF, Klem I, Parker MA, Jaroudi WA, Meine TJ, White JB, Elliott MD, Kim HW, Judd RM, Kim RJ. Detection of myocardial damage in patients with sarcoidosis. Circulation. 2009 Nov 17;120(20):1969-77. doi: 10.1161/CIRCULATIONAHA.109.851352. Epub 2009 Nov 2.

    PMID: 19884472BACKGROUND

  • Lobert P, Brown RK, Dvorak RA, Corbett JR, Kazerooni EA, Wong KK. Spectrum of physiological and pathological cardiac and pericardial uptake of FDG in oncology PET-CT. Clin Radiol. 2013 Jan;68(1):e59-71. doi: 10.1016/j.crad.2012.09.007. Epub 2012 Nov 22.

    PMID: 23177651BACKGROUND

  • Campian ME, Verberne HJ, Hardziyenka M, de Groot EA, van Moerkerken AF, van Eck-Smit BL, Tan HL. Assessment of inflammation in patients with arrhythmogenic right ventricular cardiomyopathy/dysplasia. Eur J Nucl Med Mol Imaging. 2010 Nov;37(11):2079-85. doi: 10.1007/s00259-010-1525-y. Epub 2010 Jul 6.

    PMID: 20603720BACKGROUND

  • Soejima K, Yada H. The work-up and management of patients with apparent or subclinical cardiac sarcoidosis: with emphasis on the associated heart rhythm abnormalities. J Cardiovasc Electrophysiol. 2009 May;20(5):578-83. doi: 10.1111/j.1540-8167.2008.01417.x. Epub 2009 Jan 9.

    PMID: 19175448BACKGROUND

  • Williams G, Kolodny GM. Suppression of myocardial 18F-FDG uptake by preparing patients with a high-fat, low-carbohydrate diet. AJR Am J Roentgenol. 2008 Feb;190(2):W151-6. doi: 10.2214/AJR.07.2409.

    PMID: 18212199BACKGROUND

  • Langah R, Spicer K, Gebregziabher M, Gordon L. Effectiveness of prolonged fasting 18f-FDG PET-CT in the detection of cardiac sarcoidosis. J Nucl Cardiol. 2009 Sep-Oct;16(5):801-10. doi: 10.1007/s12350-009-9110-0. Epub 2009 Jun 23.

    PMID: 19548047BACKGROUND

Biospecimen

Retention: NONE RETAINED

ACE inhibitors and CRP will be measured.

MeSH Terms

Conditions

SarcoidosisArrhythmogenic Right Ventricular DysplasiaCardiomyopathies

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System DiseasesHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Paul Broadhurst, Consultant

    NHS Grampian

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul Broadhurst, Consultant

CONTACT

01224559308paul.broadhurst@nhs.net

Dana Dawson, Consultant

CONTACT

01224437969dana.dawson@abdn.ac.uk

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2016

First Posted

December 12, 2016

Study Start

August 1, 2015

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

October 11, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)