RESynchronisation in Patients With Heart Failure and a Normal QRS Duration

Heart Failure, Congestive Clinical Trial

— RESPOND  

Official title:

RESynchronisation in Patients With Heart Failure and a Normal QRS Duration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00480051
• Other study ID #: 2007CD002.GH
• Status: Completed
• Phase: Phase 3
• First received: May 29, 2007
• Last updated: February 27, 2017
• Start date: July 2007
• Est. completion date: February 2010

Study information

• Verified date: February 2017
• Source: Heart of England NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients who have heart failure and have electrical evidence of delay in the contraction of the left ventricle on an ECG tracing of the heart are eligible for biventricular pacing. Recent work has suggested that patients with heart failure who do not have electrical evidence of conduction delay (normal QRS) may benefit from biventricular pacing. The reliance on ECGs to determine the presence of dyssynchrony is widespread, although the ECG alone is not 100% sensitive and specific. ECG criteria for de-synchrony in heart failure patients are estimated to pick up only 30% of patients with dyssynchrony, and results in patients missing out on a potentially important treatment advance.

We would like to study patients with heart failure who have normal ventricular activation on their ECGs to see whether we can predict those patients who will respond to biventricular pacing.

Description:

AIMS and Objectives A randomised controlled clinical trial

Primary objective

• Improvements in 6-min walking distance

Secondary objectives Determine

1. Symptomatic improvement in quality of life, using the Minnesota Living with Heart Failure questionnaire

2. Change in NT pro-BNP and echocardiographic parameters of LV function

3. Does MRI Dyssynchrony Index (CMR-TSI) predicts responders.

4. Morbidity and Mortality using CARE-HF definitions

5. Packer combined clinical composite score

Study Design A pilot randomised controlled clinical trial 60 patients. The biventricular pacemaker with be optimized for both A-V delay and V-V delay.

Subject Selection Source - Patients attending Good Hope Hospital, Sandwell Hospital Centres involved - 2 Eligible Participants - 60 patients with heart failure and narrow QRS.

Inclusion Criteria Sinus rhythm Symptomatic heart failure - NYHA class III or IV ECG QRS duration less than 120 milliseconds LV ejection fraction of less than 35% on echocardiography using Simpsons technique.

Able to give informed consent

Exclusion Criteria Age below 18 Current or planned pregnancy Patient refusal Ventricular tachycardia or ventricular fibrillation Current or recent (within last 30 days) involvement in other studies Requires implantable cardioverter defibrillator (ICD) according to NICE criteria for implantation (England and Wales)

Definition of clinical response:- 20% improvement in 6 minute walk distance or any improvement from 0

Definition of echocardiographic response:- 15% or greater decrease in left ventricular end systolic volume

Follow up 6 weeks and 6 monthly thereafter. Interim results at 6 months. Analysis of results, echocardiograms, MRI and BNP will be blind Walk distance to be measured by unblinded observer and by pedometer.

Randomisation:

Numbered envelopes will be prepared by sponsor (Heart of England NHS Foundation Trust) and kept from researchers. After informed consent, the patient will be enrolled and the technician will draw the result.

This trial was known as the Birmingham biventricular pacing in patients unselected for dyssynchrony (BIPIDS).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Sinus rhythm

• Symptomatic heart failure - NYHA class III or IV

• ECG QRS duration less than 120 milliseconds

• LV ejection fraction of less than 35% on echo

• Able to give informed consent

Exclusion Criteria:

• Age below 18

• Current or planned pregnancy

• Patient refusal

• Ventricular tachycardia or ventricular fibrillation

• Current or recent (within last 30 days) involvement in other studies

• Requires implantable cardioverter defibrillator (ICD)

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Congestive

Intervention

Device:
• Cardiac Resynchronization Pacing

Locations

Country	Name	City	State
United Kingdom	Sandwell Hospital	Birmingham
United Kingdom	Good Hope Hospital	Sutton Coldfield

Sponsors (2)

Lead Sponsor	Collaborator
Heart of England NHS Trust	Sandwell & West Birmingham Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvements in 6-min walking distance		6 months
Secondary	Symptomatic improvement in quality of life, using the Minnesota Living with Heart Failure questionnaire		6 months
Secondary	Change in NT pro-BNP and echocardiographic parameters of LV function		6 months
Secondary	Does MRI Dyssynchrony Index (CMR-TSI) predicts responders		6 months