NCT02917395

Brief Summary

Population study- patients with obstructive hypertrophic cardiomyopathy that are treated with disopyramide. Tow echo examination, few hours apart, that includes strain rate will be done to each patient. The first, after taking the regular medical treatment excluding disopyramide and the last one after taking the disopyramide.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

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

First Submitted

Initial submission to the registry

September 27, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

October 4, 2016

Status Verified

October 1, 2016

Enrollment Period

1.2 years

First QC Date

September 27, 2016

Last Update Submit

October 3, 2016

Conditions

Cardiomyopathy

Keywords

hypertrophic cardiomyopathy, disopyramide,

Outcome Measures

Primary Outcomes (1)

  • Tow echo examination, few hours apart, that includes strain rate will be done to each patient. The first, after taking the regular medical treatment excluding disopyramide and the last one after taking the disopyramide

    2-3 hours

Study Arms (1)

echo

EXPERIMENTAL

Population study- patients with obstructive hypertrophic cardiomyopathy that are treated with disopyramide. Tow echo examination, few hours apart, that includes strain rate will be done to each patient. The first, after taking the regular medical treatment excluding disopyramide and the last one after taking the disopyramide.

Device: echocardiography

Interventions

echocardiographyDEVICE

Tow echo examination, few hours apart, that includes strain rate will be done to each patient. The first, after taking the regular medical treatment excluding disopyramide and the last one after taking the disopyramide.

echo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • hypertrophic cardiomyopathy that treated with disopyramid

You may not qualify if:

  • pregnancy
  • pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

CardiomyopathiesCardiomyopathy, Hypertrophic

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Idit Yedidya, MD

    Rabin Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Idit Yedidya, md

CONTACT

972-3-9372242iditye@clalit.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of echo lab- hashron campus in Rabin medical center

Study Record Dates

First Submitted

September 27, 2016

First Posted

September 28, 2016

Study Start

November 1, 2016

Primary Completion

January 1, 2018

Study Completion

June 1, 2018

Last Updated

October 4, 2016

Record last verified: 2016-10