NCT02434159

Brief Summary

The purpose of this study is to determine if detailed scanning of the heart before biventricular device insertion will improve outcomes for heart failure patients.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable heart-failure

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

May 1, 2012

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

April 30, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 5, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Last Updated

May 5, 2015

Status Verified

April 1, 2015

Enrollment Period

5.3 years

First QC Date

April 30, 2015

Last Update Submit

April 30, 2015

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • 6 minute walk test

    6 months

Study Arms (2)

Scan

ACTIVE COMPARATOR

Heart scan prior to device insertion

Other: Heart scan

No scan

NO INTERVENTION

No heart scan prior to device insertion

Interventions

Heart scanOTHER
Scan

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18, \<90
  • Patients with moderate or severe heart failure ( NYHA functional class II-IV) due to ischaemic or non-ischaemic cardiomyopathy.
  • QRS duration \>120ms on 12 lead ECG
  • LVEF \< 35%
  • LVEDD \>55 mm
  • Patients on optimum medical treatment for heart failure. The doses of these medications have been stable for 3 months.

You may not qualify if:

  • Patients with a cardiac or cerebral ischemic event within the previous three months prior to recruitment
  • Patients who had had an atrial arrhythmia within one month prior to recruitment
  • Patients with a systolic blood pressure of more than 170 or less than 80 mm Hg
  • Patients with a heart rate of more than 140 beats per minute
  • Patients with severe renal failure (eGFR \< 30)
  • Patients with a history of allergy to iodine based contrast agents
  • Predicted life expectancy \< 1 year
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College London Hospital

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

Vanessa Cobb

CONTACT

nesscobb@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2015

First Posted

May 5, 2015

Study Start

May 1, 2012

Primary Completion

September 1, 2017

Last Updated

May 5, 2015

Record last verified: 2015-04

Locations

GB(1)