Standard Care Versus Triventricular Pacing in Heart Failure

Heart Failure Clinical Trial

— STRIVE HF  

Official title:

A Multicentre Randomised Control Trial Comparing Standard Cardiac Resynchronisation Pacing With Triventricular Pacing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02529410
• Other study ID #: 15/LO/0183
• Status: Recruiting
• Phase: Phase 3
• First received: August 17, 2015
• Last updated: February 29, 2016
• Start date: August 2015
• Est. completion date: August 2017

Study information

• Verified date: February 2016
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: Simon Claridge, MBBS
• Phone: 02071887188
• Email: simon.claridge[@]kcl.ac.uk
• Is FDA regulated: No
• Health authority: King's College LONDON United Kingdom:
• Study type: Interventional

Clinical Trial Summary

100 pt multicentre study 50 pts randomised to triventricular pacemaker, 50 to biventricular pacemaker Feasibility study with 6 month outcome data

Description:

100 patients with QRS duration (120-150ms LBBB) for device insertion as per ESC guidelines 2013 will be recruited to the study from 10 centres. Patients will undergo the pre-operative work up that is typical of their institution (for example at the GSTT site this will include cardiac MRI, cardiopulmonary exercise testing (CPET), 6 minute walk test , bloods including Nt pro BNP, Minnesota living with heart failure questionnaire (MLWHFQ), 2D/3D echocardiogram and the collection of demographic data.)

Patients will then be randomised in a 1:1 fashion to receive either the Triventricular device or the conventional biventricular device.

Participants will then be followed up as per the implanting institution's typical follow up. (for example at GSTT this will include 6 week atrio-ventricular and ventricular-ventricular optimisation (if patients have a device that does not autooptimise) and review by a clinician as well as a 6 month follow up at which point the CPET, 6 minute walk test , MLWHFQ, bloods including Nt pro BNP, 2D/3D echocardiogram and the collection of demographic data will be repeated.)

Regardless of the institution's own follow up, a 6 week (4-8 week) and 6 month (5-9month) follow up appointment will form part of the study protocol. The 6 week check will be take the form of a standard clinical pacing check with physician input if it is deemed necessary as per the host institution's usual standard of care/ (usually one would imagine if a problem of therapy delivery is noted)

The 6 month follow up will allow for patient and device follow up. This will require 2D echocardiography, 6 min walk test, MLWHFQ and NtproBNP measurement. Where possible institutions will be encouraged to perform CPET and 3D echocardiography pre implant and at 6 months.

For determining the " response rate", a positive response will be defined as an absolute reduction of LVESV by 15%. In order to determine the magnitude of response then the change in LVESV will be assessed as a continuous variable.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Class 1b Indication for CRT (LBBB QRS120-150ms) as per ESC guidelines 2013

• Participant is willing and able to give informed consent for participation in the study.

• Male or Female, aged 18 years or above.

• Female participants of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter

• Able (in the Investigators opinion) and willing to comply with all study requirements.

• Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.

Exclusion Criteria:

• Female participant who is pregnant, lactating or planning pregnancy during the course of the study.

• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.

• Insufficient capacity to consent to the study

• QRS >150ms and Non-LBBB morphology 120-150ms

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Procedure:
• Cardiac Resynchronisation Therapy

Locations

Country	Name	City	State
United Kingdom	Guy's and St Thomas Hospital Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of achieving and maintaining triventricular pacing at 6 months	Percentage of patients having triventricular pacing at 6 months	6 months	No
Secondary	Proportion of patients who successfully reverse remodel as per echo (success being defined as a reduction in end systolic volume of > 15%	outcome	6 months	No
Secondary	Proportionate effect of intervention and comparator with regard to reverse remodelling (comparison of % reduction in left ventricular end systolic volume )	outcome	6 months	No
Secondary	Proportion of patients who successfully reverse remodel as per echo (success being defined as a reduction in end systolic volume of > 15% with prespecified subgroups (AF and aetiology)	6 months	6 months	No
Secondary	Proportionate effect of intervention and comparator with regard to reverse remodelling (comparison of % reduction in left ventricular end systolic volume ) (AF and aetiology)	outcome	6 months	No
Secondary	Mean change in Nt proBNP in patients with triventricular devices compared with biventricular devices (pg/ml)	outcome	6 months	No
Secondary	Comparison of effect of biventricular and triventricular pacing on scores in the Minnesota Living with Heart Failure Questionnaire	outcome	6 months	No
Secondary	Comparison of effect of biventricular and triventricular pacing on change in 6 minute walk test (metres)	outcome	6 months	No
Secondary	Percentage change in Nt proBNP in patients with triventricular devices compared with biventricular devices	outcome	6 months	No
Secondary	Comparison of percentage of shocks delivered in triventricular arm vs biventricular arm	outcome	6 months	Yes