Heart FailureNCT02748876
Effect of His-Ventricular (HV) Interval Optimisation in Cardiac Resynchronisation Therapy
A study testing His-Ventricular (HV) optimisation in people with Heart Failure, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- His-Ventricular (HV) optimisation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Sep 2016to 15 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Cross-over Pilot Study of the Effect of His-Ventricular (HV) Interval Optimisation in Cardiac Resynchronisation Therapy
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.
- Conditions
- Heart Failure
- Being tested
- His-Ventricular (HV) optimisation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
His-Ventricular (HV) optimisationOther
Optimisation of atrioventricular pacing interval
| Study group | Role | What they receive |
|---|---|---|
| His-Ventricular (HV)-optimised | Experimental | His-Ventricular (HV) optimised atrioventricular delay Receives: Other: His-Ventricular (HV) optimisation |
| Non-optimised | No intervention | Standard atrioventricular delay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in amino-terminal pro-B-type natriuretic peptide (NT-proBNP)
Measured: 7 months and 11 months
Secondary outcomes (3)
Increase in 6-min walk test distance by ≥25 m
Measured: 7 months and 11 months
≥5points improvement in the short Kansas City Cardiomyopathy Questionnaire score
Measured: 7 months and 11 months
Reduction of left ventricular end-diastolic volume.
Measured: 7 months and 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study start29 Sep 2016
- Primary completion28 Apr 2017
- Study completion15 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02748876
- Sponsor's protocol ID
- 113
- Status last verified
- Jul 2019
- First submitted
- 20 Apr 2016
- Last updated
- 17 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Cross-over Pilot Study of the Effect of His-Ventricular (HV) Interval Optimisation in Cardiac Resynchronisation Therapy
- ClinicalTrials.gov ID
- NCT02748876
- Acronym / sponsor ID
- 113
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Study start
- 29 Sep 2016 (actual)
- Primary completion
- 28 Apr 2017 (actual)
- Study completion
- 15 Mar 2018 (actual)
- First posted
- 22 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| His-Ventricular (HV)-optimised | Experimental | Other: His-Ventricular (HV) optimisationHis-Ventricular (HV) optimised atrioventricular delay |
| Non-optimised | No intervention | –Standard atrioventricular delay |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- Severe valve disease or previous valve replacement
- Previous atrial flutter ablation
- Chronic kidney disease Stage 3 or above
- Recent myocardial infarction
- Ongoing cardiac ischaemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| His-Ventricular (HV) optimisationOptimisation of atrioventricular pacing interval | Other | His-Ventricular (HV)-optimised |
Primary outcome
Change in amino-terminal pro-B-type natriuretic peptide (NT-proBNP)
Time frame: 7 months and 11 months
3 secondary outcomes
Increase in 6-min walk test distance by ≥25 m
Time frame: 7 months and 11 months
≥5points improvement in the short Kansas City Cardiomyopathy Questionnaire score
Time frame: 7 months and 11 months
Reduction of left ventricular end-diastolic volume.
Time frame: 7 months and 11 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing His-Ventricular (HV) optimisation in people with Heart Failure, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in amino-terminal pro-B-type natriuretic peptide (NT-proBNP) (time frame: 7 months and 11 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2019; AzTrials last refreshed its copy on 30 Oct 2026.