Contractile Reserve in Dyssynchrony: A Novel Principle to... | NCT02525185

Studies
Contractile Reserve in Dyssynchrony: A Novel Principle to Identify Candidates for Cardiac Resynchronization Therapy

NCT02525185

Sponsor

Oslo University Hospital

Status

Completed

Last Update Posted

Nov 1, 2023Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Heart Failure
Cardiomyopathy

Interventions

Diagnostic interventions; PET, MRI, cardiac ultrasound.

Countries

Belgium
Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015

Primary Completion Date

Jul 1, 2018Actual

Completion Date

Aug 2023Actual

First Submitted Date

Aug 11, 2015

First Submission Date that Met QC Criteria

Aug 13, 2015

First Posted Date

Aug 17, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 31, 2023

Last Update Posted Date

Nov 1, 2023Actual

Name	Class
Universitaire Ziekenhuizen KU Leuven	OTHER
Rennes University Hospital	OTHER
Karolinska University Hospital	OTHER
Onze Lieve Vrouwziekenhuis Aalst

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Cardiac resynchronisation therapy (CRT) has been documented to be a powerful treatment in patients with severe congestive heart failure. However, 30-40% of patients receiving a CRT are non-responders. In this study the investigators will use a previously validated method to estimate myocardial segment work non-invasively by speckle-tracking echocardiography and blood pressure. Furthermore, cardiac magnetic resonance imaging (CMR) with late gadolinium enhancement (LGE) will be performed in feasible subjects. The main purpose of the study is to determine if myocardial work by echocardiography in combination with viability assessment by LGE-CMR can predict response to CRT.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Name	Type	Description	Arm Group Labels	Other Names
Diagnostic interventions; PET, MRI, cardiac ultrasound.	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reverse remodelling at 6 months follow-up	Measured by left ventricular end-systolic volume reduction of at least 15% assessed by echocardiography	6 months

Secondary Outcomes

Measure	Description	Time Frame
Reverse remodelling at 12 months follow-up	Measured by left ventricular end-systolic volume reduction of at least 15% assessed by echocardiography	12 months
Quality of Life Changes	Changes in quality of life measured by the Minnesota Living With Heart Failure Questionnaire

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject is indicated for CRT device according to European Society of Cardiology (ESC) guidelines from 2013.
Subject is willing to sign informed consent form and is 18 years or older.

Exclusion Criteria:

Right bundle branch block.
Recent myocardial infarction, within 40 days prior to enrollment.
Subject underwent coronary artery bypass graft (CABG) or valve surgery, within 90 days.
Post heart transplantation, or is actively listed on the transplantation list, or has reasonable probability (per investigator's discretion) of undergoing transplantation in the next year
Implanted with a LV assist device (LVAD), or has reasonable probability (per investigator's discretion) of receiving a LVAD in the next year
Severe aortic stenosis (with a valve area of <1.0 cm2 or significant valve disease expected to be operated on within study period).
Complex and uncorrected congenital heart disease.
Breastfeeding women or women of child bearing potential.
Enrolled in one or more concurrent studies that would confound the results of this study.
Impossible to obtain LV volumes by echocardiography

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects who are indicated for CRT device according to European Society of Cardiology (ESC) guidelines (2013).

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Otto A Smiseth, MD PhD	Oslo University Hospital	Principal Investigator
Jens-Uwe Voigt, MD PhD	Universitaire Ziekenhuizen KU Leuven	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitaire Ziekenhuizen Leuven		Leuven			Belgium
Oslo University Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32918449	Result	Aalen JM, Donal E, Larsen CK, Duchenne J, Lederlin M, Cvijic M, Hubert A, Voros G, Leclercq C, Bogaert J, Hopp E, Fjeld JG, Penicka M, Linde C, Aalen OO, Kongsgard E, Galli E, Voigt JU, Smiseth OA. Imaging predictors of response to cardiac resynchronization therapy: left ventricular work asymmetry by echocardiography and septal viability by cardiac magnetic resonance. Eur Heart J. 2020 Oct 14;41(39):3813-3823. doi: 10.1093/eurheartj/ehaa603.
39570213

ID	Term
D006333	Heart Failure
D009202	Cardiomyopathies

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

ID	Term
C062942	2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole
D009682	Magnetic Resonance Spectroscopy

ID	Term
D013057	Spectrum Analysis
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques