Effect of His-Ventricular (HV) Interval Optimisation in Cardiac Resynchronisation Therapy
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
His-Ventricular (HV) optimisation
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of heart failure
- Referred for cardiac resynchronisation therapy (CRT) with or without defibrillator
- In sinus rhythm
- Patients must have a telephone
- Ability to give informed consent
- Ability to complete the study
Exclusion Criteria:
- Severe valve disease or previous valve replacement
- Previous atrial flutter ablation
- Chronic kidney disease Stage 3 or above
- Recent myocardial infarction
- Ongoing cardiac ischaemia
- Infiltrative cardiomyopathy
- Wolff-Parkinson White syndrome
- Presence of second or third degree heart block
- <90% biventricular pacing at 3 months
- Hypertrophic cardiomyopathy
- Pregnancy or breastfeeding
- On treatment for hypothyroidism or hyperthyroidism
Sites / Locations
- Castle Hill Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
His-Ventricular (HV)-optimised
Non-optimised
Arm Description
His-Ventricular (HV) optimised atrioventricular delay
Standard atrioventricular delay
Outcomes
Primary Outcome Measures
Change in amino-terminal pro-B-type natriuretic peptide (NT-proBNP)
Secondary Outcome Measures
Increase in 6-min walk test distance by ≥25 m
≥5points improvement in the short Kansas City Cardiomyopathy Questionnaire score
Reduction of left ventricular end-diastolic volume.
Full Information
NCT ID
NCT02748876
First Posted
April 20, 2016
Last Updated
July 15, 2019
Sponsor
Hull University Teaching Hospitals NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT02748876
Brief Title
Effect of His-Ventricular (HV) Interval Optimisation in Cardiac Resynchronisation Therapy
Official Title
A Randomised Cross-over Pilot Study of the Effect of His-Ventricular (HV) Interval Optimisation in Cardiac Resynchronisation Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
September 29, 2016 (Actual)
Primary Completion Date
April 28, 2017 (Actual)
Study Completion Date
March 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hull University Teaching Hospitals NHS Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Cardiac resynchronisation therapy (CRT) is a specialised type of pacemaker used in patients with severe heart failure to improve symptoms and survival. Approximately one third of patients treated with CRT do not notice significant improvement in their symptoms and this may be due to inadequate co-ordination between the upper and lower chambers of the heart (atrioventricular dyssynchrony).
The investigators propose a new method to achieve atrioventricular synchrony in CRT based on measurements of electrical conduction from within the heart. Patients referred for CRT implantation at Castle Hill Hospital are eligible to participate. During CRT implantation, additional measurements, will be recorded from within the heart. After implantation, device settings will be adjusted to either standard or electrophysiologically-optimised settings with cross-over at 4 months.
The investigators hypothesis is that patients with optimised settings will derive additional benefit compared to patients with standard pacemaker-determined settings.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
His-Ventricular (HV)-optimised
Arm Type
Experimental
Arm Description
His-Ventricular (HV) optimised atrioventricular delay
Arm Title
Non-optimised
Arm Type
No Intervention
Arm Description
Standard atrioventricular delay
Intervention Type
Other
Intervention Name(s)
His-Ventricular (HV) optimisation
Intervention Description
Optimisation of atrioventricular pacing interval
Primary Outcome Measure Information:
Title
Change in amino-terminal pro-B-type natriuretic peptide (NT-proBNP)
Time Frame
7 months and 11 months
Secondary Outcome Measure Information:
Title
Increase in 6-min walk test distance by ≥25 m
Time Frame
7 months and 11 months
Title
≥5points improvement in the short Kansas City Cardiomyopathy Questionnaire score
Time Frame
7 months and 11 months
Title
Reduction of left ventricular end-diastolic volume.
Time Frame
7 months and 11 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of heart failure
Referred for cardiac resynchronisation therapy (CRT) with or without defibrillator
In sinus rhythm
Patients must have a telephone
Ability to give informed consent
Ability to complete the study
Exclusion Criteria:
Severe valve disease or previous valve replacement
Previous atrial flutter ablation
Chronic kidney disease Stage 3 or above
Recent myocardial infarction
Ongoing cardiac ischaemia
Infiltrative cardiomyopathy
Wolff-Parkinson White syndrome
Presence of second or third degree heart block
<90% biventricular pacing at 3 months
Hypertrophic cardiomyopathy
Pregnancy or breastfeeding
On treatment for hypothyroidism or hyperthyroidism
Facility Information:
Facility Name
Castle Hill Hospital
City
Hull
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of His-Ventricular (HV) Interval Optimisation in Cardiac Resynchronisation Therapy
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