RESynchronisation in Patients with heart failure and a Normal QRS Duration (RESPOND)
Completed
- Conditions
- Cardiac failureCirculatory System
- Registration Number
- ISRCTN17623123
- Lead Sponsor
- Heart of England Foundation NHS Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
1. Sinus rhythm
2. Symptomatic heart failure - New York Heart Association (NYHA) class III or IV
3. Electrocardiogram (ECG) QRS duration less than 120 milliseconds
4. Left ventricular (LV) ejection fraction of less than 35% on echocardiography using Simpson?s methodology
5. Able to give informed consent
Exclusion Criteria
1. Age below 18
2. Current or planned pregnancy
3. Patient refusal
4. Ventricular tachycardia or ventricular fibrillation
5. Current or recent (within last 30 days) involvement in other studies
6. Requires implantable cardioverter defibrillator (ICD)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvements in 6-minute walking distance (distance that the patient can walk at their own pace in 6 minutes) assessed at baseline, 6 weeks and 6 months. 20% increase in distance walked in 6 minutes, or any increase from 0 will be taken as a significant endpoint.
- Secondary Outcome Measures
Name Time Method 1. Symptomatic improvement in quality of life at baseline, 6 weeks after intervention and 6 monthly thereafter, assessed using the Minnesota Living with Heart Failure questionnaire <br>2. Change in N-terminal pro-beta natriuretic peptide (NT pro-BNP) and echocardiographic parameters of LV function at baseline, 6 weeks after intervention and 6 monthly thereafter. 15% decrease in end systolic volume will be taken as a significant endpoint<br>3. Assessing whether magnetic resonance imaging (MRI) Dyssynchrony Index (cardiovascular magnetic resonance tissue synchronisation imaging [CMR-TSI]) predicts responders (at baseline) <br>4. Packer outcome at 6 weeks after intervention and 6 monthly thereafter <br>5. Hospitalisation will be monitored at 6 weeks after intervention and 6 monthly thereafter <br>6. Mortality will be monitored at 6 weeks after intervention and 6 monthly thereafter