NCT01947543

Brief Summary

The aim of this study is to screen a well characterized patient population with ventricular tachycardia of unknown origin and treated with an implantable cardioverter-defibrillator (ICD) for mutations in the calmodulin genes.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

August 27, 2013

Completed
24 days until next milestone

First Posted

Study publicly available on registry

September 20, 2013

Completed
3.3 years until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

April 11, 2018

Status Verified

April 1, 2018

Enrollment Period

1.2 years

First QC Date

August 27, 2013

Last Update Submit

April 10, 2018

Conditions

Ventricular Tachycardia

Outcome Measures

Primary Outcomes (1)

  • Mutations in the calmodulin genes

    1 month.

Study Arms (2)

Ventricular tachycardia

Patients with ventricular tachycardia of unknown origin treated with an ICD.

Family members

Family members (parents, siblings and children) for patients with results showing mutations in the calmodulin genes.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with ventricular tachycardia of unknown origin and treated with an ICD

You may qualify if:

  • Patients with ventricular tachycardia of unknown origin that have been treated with an ICD
  • Signed and dated informed consent

You may not qualify if:

  • \- Inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, Örebro University Hospital

Örebro, 70185, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

TachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ole Fröbert, MD, Ph.D.

    Department of Cardiology, Örebro University Hospital, Örebro, Sweden

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

August 27, 2013

First Posted

September 20, 2013

Study Start

January 1, 2017

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

April 11, 2018

Record last verified: 2018-04

Locations

SE(1)