Diastolic Heart FailurePREFECTUSNCT03338374
Cardiac Resynchronisation Therapy Versus Rate-responsive Pacing in Heart Failure With Preserved Ejection Fraction
A study testing Biventricular pacemaker in people with Diastolic Heart Failure, run by Cardiff and Vale University Health Board at 2 sites in United Kingdom.
Trial summary
Half of patients with heart failure have normal heart pumping function (Heart failure with Preserved Ejection Fraction, HFpEF), most commonly characterised by breathlessness on exercise. A number of mechanisms are responsible, but frequently patients are unable to raise their heart rate on exercise. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diastolic Heart Failure
- What is being tested?
- Biventricular pacemaker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 27 Nov 2017to 30 May 2022
- 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
- Confirmed HFpEF as described above
- Chronotropic incompetence as described above
- Ongoing exertional breathlessness of NYHA Grade II or worse
- Ability to understand and sign written consent form
- Males and females, age >18 years
- Ability to participate in follow-up appointments at 3 and 6 months post-implantation
- Ability to complete a cardiopulmonary exercise test
Who cannot join
- Any contraindication to implantation of permanent pacemaker, namely unresolved infective process or sepsis, vascular access difficulties, advanced neoplastic process, expected lifespan less than 1 year or patient choice
- Ejection fraction <50%
- Known valvular disease graded severe or moderate-to-severe
- Cardiac arrhythmia (paroxysmal or persistent) within 1 year of recruitment
- Exertional chest pain suggestive of angina or personal history of coronary artery disease without subsequent revascularisation, or coronary angiogram within the past 5 years demonstrating >50% stenosis in ≥ 1 epicardial coronary artery
- Significant chronic lung disease (FEV1 <80%)
- Inability to complete follow-up process for any reason not defined above
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Cardiff and Vale University Health Board
Cardiff, Mid Glamorgan, CF14 4XW
Cardiff Metropolitan University
Cardiff, Mid Glamorgan, CF23 6XD
About this study
Official title: Heart Failure With Preserved Ejection Fraction Treated by Cardiac Resynchronisation Therapy Versus Rate Responsive Pacing: A Mechanistic Study
Half of patients with heart failure have normal heart pumping function (Heart failure with Preserved Ejection Fraction, HFpEF), most commonly characterised by breathlessness on exercise. A number of mechanisms are responsible, but frequently patients are unable to raise their heart rate on exercise. This can be treated by a 'rate-responsive pacemaker' (RRP), which detects exercise and increases the heart rate accordingly. Some beneficial effects on echocardiographic parameters have been reported with exercise programmes. However, evidence based treatment options are limited in this group and therapy mainly relies on water tablets and treatment of blood pressure.
Cardiac resynchronisation therapy (CRT) is a technique using specialised 'biventricular' pacemakers that is well established in heart failure with reduced pump function. Patients who respond to this treatment have lower risk of death and hospitalisation and usually feel better. CRT is not currently used in HFpEF. The PROSPECT trial showed that some patients with relatively preserved heart function exhibited similar benefits to those with poor pump function, but this has not been formally tested. CRT aims to make the heart beat in a more synchronised way. Patients with HFpEF commonly have evidence of reduced heart synchronisation.
The investigators plan to assess the feasibility of using a prospective cohort study to assess the incremental benefit of CRT over and above RRP in patients with HFpEF. 10 patients with HFpEF and insufficient heart rate will be recruited and will undergo exercise testing, heart scanning and symptom questionnaires. A biventricular pacemaker will be implanted and programmed to RRP for 12 weeks before repeating the tests. After this, the investigators will non-invasively programme the pacemaker to CRT for 12 weeks and repeat the functional tests. If incremental benefit is shown with CRT the echocardiograms will be analysed in detail to determine the mechanism of change. The study participants will be invited to continue their involvement in a study extension. This will involve non-invasively programming the pacemakers to optimise their function guided by the results of the echocardiograms in the first two phases of the study. After a further 12 weeks, the functional assessments will be repeated. If no benefit is seen with CRT after initial analysis, the participant involvement will end.
Read the detailed description
This is an exploratory single-centre, open label, non-randomised, prospective cohort study comparing rate responsive pacing (RRP) with CRT in patients with confirmed HFpEF and chronotropic incompetence.
Setting:
The study will be conducted in Cardiff and Vale University Health Board, with patients drawn from Cardiology clinics and inpatient wards. Follow-up assessments will be conducted at Cardiff School of Sport, a research facility at a university campus close to the main hospital.
Number of subjects planned:
10 patients. This will be sufficient to establish estimates of variability in the diastolic reserve index (see below), allow estimation of treatment difference and gauge acceptability.
Target population:
Subjects with HFpEF and chronotropic incompetence
Endpoints:
Systolic and diastolic longitudinal reserve index are calculated by the following formulae:
Systolic reserve = Δs' x [1-(1/s'rest)] Diastolic reserve = Δe' x [1-(1/e'rest)]
These are known to be impaired in patients with HFpEF and are a marker of adaptation to exercise in terms of filling pressures and left ventricular relaxation. Tan et al report a significant difference between the results seen with 56 patients with HFpEF and 27 control subjects on exercise echocardiography with semi-supine bicycle.16 Patient characteristics were similar to those of our proposed study group (Ejection fraction (EF) >50%, New York Heart Association (NYHA) classification grade II, HFpEF according to Vasan and Levy criteria).28
The investigators will therefore investigate diastolic and systolic reserve index as possible endpoints of a future study into the efficacy of CRT versus RRP in HFpEF patients.
Planned interventions:
Visit 1 - Baseline Assessments: Patients will undergo initial assessment of baseline characteristics by echocardiography, cardiopulmonary exercise testing, 6-minute walk test (6MWT) and Minnesota Living with Heart Failure Questionnaire (MLHFQ). (Visit length: approx. 4 hours)
Visit 2 - Device Implantation (≤ 7 days after baseline assessments completed):
Eligible subjects will undergo implantation of a biventricular pacemaker under normal laboratory conditions. The device will be programme to administer rate-responsive pacing (DDDR). They will return to pacing clinic a week later for a programming check; during this visit, they will also undergo a chest x-ray according to local protocol to ensure correct lead placement (Visit length: 1 day + 2 hours)
Visit 3 - Assessments and Device Reprogramming After 12 weeks, the baseline parameters will be reassessed and patients will then have their device non-invasively reprogrammed to CRT. (Visit length: approx. 4 hours)
Visit 4 - Assessments After a further 12 weeks, the baseline assessments will be repeated. The pacemaker will be non-invasively reprogrammed to DDDR mode and the patient will go home. (Visit length: approx. 4 hours)
Optional extension (pending analysis of results) Visit 5 - Reprogramming If incremental benefit has been demonstrated with CRT above the benefit of RRP, the echocardiograms will be examined to establish the mechanism of improvement. Subjects will be invited to participate in a study extension using multisite technology. The device will be non-invasively reprogrammed to optimise the CRT settings targeted specifically for the mechanism identified. (Visit length: approx. 3 hour)
Visit 6 - Assessments 12 weeks after the final reprogramming, patients will attend for a final set of assessments as per baseline. Participant involvement will then cease. (Visit length: approx. 4 hours)
Total contact time with research team: Approximately 27 hours (22 hours without extension)
- Conditions
- Diastolic Heart Failure
- Being tested
- Biventricular pacemaker
- Keywords
- Cardiac chronotropy, Cardiac resynchronisation therapy, Rate responsive pacemaker, Heart failure with preserved ejection fraction
- Medical subject headings
- Heart Failure, Diastolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biventricular pacemakerDevice
Also called Rate responsive pacing
All subjects will receive a biventricular pacemaker at implantation. Programming will initially be to dual-chamber, dual-function rate-responsive pacing for 12 weeks; following reassessment, device will be reprogrammed to biventricular pacing for a further 12 weeks. Optional study extension: if incremental benefit is shown for biventricular pacing above dual chamber, the mechanism will be sought using echocardiographic evidence and the devices will be optimised according to this mechanism of action to see whether further benefit can be achieved.
| Study group | Role | What they receive |
|---|---|---|
| Biventricular Pacemaker | Experimental | All subjects to be in a single study group experiencing all interventions. Receives: Device: Biventricular pacemaker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diastolic reserve index
The change in e' between rest and exercise, as measured by tissue Doppler in the septal and/or lateral left ventricular walls on echocardiography. To be expressed using the formula: [change in e'] x [1-(1/e' at rest)]. e' is the peak diastolic velocity of the myocardium during passive left ventricular filling.
Measured: After 12 weeks of rate responsive pacing and again after 12 weeks of biventricular pacing; study extension: after 6 weeks of optimised pacing
Systolic reserve index
The change in s' between rest and exercise, as measured by tissue Doppler in the septal and/or lateral left ventricular walls on echocardiography. To be expressed using the formula: [change in s'] x [1-(1/s' at rest)]. s' is the peak systolic velocity of the myocardium.
Measured: After 12 weeks of rate responsive pacing and again after 12 weeks of biventricular pacing; study extension: after 6 weeks of optimised pacing
Secondary outcomes (8)
Global longitudinal strain
Peak systolic strain of 6 myocardial segments measured on echocardiography by speckle tracking, measured both at rest and on exercise
Measured: After 12 weeks of rate responsive pacing and again after 12 weeks of biventricular pacing; study extension: after 6 weeks of optimised pacing
Left ventricular torsion
The twisting movement of the heart can be quantified with echocardiography using speckle tracking at rest and on exercise.
Measured: After 12 weeks of rate responsive pacing and again after 12 weeks of biventricular pacing; study extension: after 6 weeks of optimised pacing
Exercise duration
Cardiopulmonary exercise testing will be used with standard local protocols to evaluate exercise duration.
Measured: After 12 weeks of rate responsive pacing and again after 12 weeks of biventricular pacing; study extension: after 6 weeks of optimised pacing
Oxygen carrying capacity
Measurement of peak ventilatory capacity (VO2 max) using cardiopulmonary exercise testing with standard local protocols, ensuring a respiratory exchange ratio of greater than 1.1 to guarantee near-maximal exercise achieved. This will be assessed using expired gas analysis, which is a standard technique.
Measured: After 12 weeks of rate responsive pacing and again after 12 weeks of biventricular pacing; study extension: after 6 weeks of optimised pacing
Distance walked in a six-minute walk test
Subjects walk down a pre-measured course, usually a hallway or corridor, and their distance achieved after six minutes is recorded.
Measured: After 12 weeks of rate responsive pacing and again after 12 weeks of biventricular pacing; study extension: after 6 weeks of optimised pacing
New York Heart Association Function Class
Standard measure of heart failure severity that correlates with outcomes. Assessed using measures of impairment in activities of daily living, such as dressing, walking.
Measured: After 12 weeks of rate responsive pacing and again after 12 weeks of biventricular pacing; study extension: after 6 weeks of optimised pacing
Minnesota Living with Heart Failure Quality of Life Score
Change in Minnesota living with heart failure questionnaire score. This questionnaire asks 21 questions relating to daily tasks of living, hobbies, social life and well-being in relation to heart failure symptoms and ascribes greater points to more severe symptoms; a higher score is therefore indicative of a lower quality of life. Scores may range between 0 and 105.
Measured: After 12 weeks of rate responsive pacing and again after 12 weeks of biventricular pacing; study extension: after 6 weeks of optimised pacing
Prognostic biomarkers
Measurement of serum N-terminal pro-B-type Natriuretic Peptide, a commonly used marker of ventricular wall stretch that correlates with heart failure severity and is adversely associated with prognosis.
Measured: After 12 weeks of rate responsive pacing and again after 12 weeks of biventricular pacing; study extension: after 6 weeks of optimised pacing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start27 Nov 2017
- Primary completion30 May 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diastolic 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
- Not applicable
- Intervention model
- Single group
- Model description
- Exploratory single-centre, open label, non-randomised, prospective cohort study
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiff and Vale University Health Board
- Sponsor type
- Other government
- Collaborators
- Abbott, Cardiff Metropolitan University
- Responsible party
- Principal investigator, Freya Lodge, Cardiff and Vale University Health Board
- Investigators
- Zaheer Yousef, MD, Study director, Cardiff and Vale University Health Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03338374
- Sponsor's protocol ID
- 17/WA/0004 190938
- Acronym
- PREFECTUS
- Status last verified
- Jun 2023
- First submitted
- 31 Aug 2017
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Access to individual participant data (IPD) will be at the discretion of the study team. No plan is currently in place to share IPD. This is a small, exploratory study where full transparency will be demonstrated in publication of results; fully-anonymised individual participant data may be referenced in publication of results.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Failure With Preserved Ejection Fraction Treated by Cardiac Resynchronisation Therapy Versus Rate Responsive Pacing: A Mechanistic Study
- ClinicalTrials.gov ID
- NCT03338374
- Acronym / sponsor ID
- PREFECTUS / 17/WA/0004 190938
- Conditions
- Diastolic Heart Failure
- Keywords
- Cardiac chronotropy, Cardiac resynchronisation therapy, Rate responsive pacemaker, Heart failure with preserved ejection fraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cardiff and Vale University Health BoardOther government
- Collaborators
- Abbott, Cardiff Metropolitan University
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 9 Nov 2017 (actual)
- 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.
Half of patients with heart failure have normal heart pumping function (Heart failure with Preserved Ejection Fraction, HFpEF), most commonly characterised by breathlessness on exercise. A number of mechanisms are responsible, but frequently patients are unable to raise their heart rate on exercise. This can be treated by a 'rate-responsive pacemaker' (RRP), which detects exercise and increases the heart rate accordingly. Some beneficial effects on echocardiographic parameters have been reported with exercise programmes. However, evidence based treatment options are limited in this group and therapy mainly relies on water tablets and treatment of blood pressure.
Cardiac resynchronisation therapy (CRT) is a technique using specialised 'biventricular' pacemakers that is well established in heart failure with reduced pump function. Patients who respond to this treatment have lower risk of death and hospitalisation and usually feel better. CRT is not currently used in HFpEF. The PROSPECT trial showed that some patients with relatively preserved heart function exhibited similar benefits to those with poor pump function, but this has not been formally tested. CRT aims to make the heart beat in a more synchronised way. Patients with HFpEF commonly have evidence of reduced heart synchronisation.
The investigators plan to assess the feasibility of using a prospective cohort study to assess the incremental benefit of CRT over and above RRP in patients with HFpEF. 10 patients with HFpEF and insufficient heart rate will be recruited and will undergo exercise testing, heart scanning and symptom questionnaires. A biventricular pacemaker will be implanted and programmed to RRP for 12 weeks before repeating the tests. After this, the investigators will non-invasively programme the pacemaker to CRT for 12 weeks and repeat the functional tests. If incremental benefit is shown with CRT the echocardiograms will be analysed in detail to determine the mechanism of change. The study participants will be invited to continue their involvement in a study extension. This will involve non-invasively programming the pacemakers to optimise their function guided by the results of the echocardiograms in the first two phases of the study. After a further 12 weeks, the functional assessments will be repeated. If no benefit is seen with CRT after initial analysis, the participant involvement will end.
Detailed description
This is an exploratory single-centre, open label, non-randomised, prospective cohort study comparing rate responsive pacing (RRP) with CRT in patients with confirmed HFpEF and chronotropic incompetence.
Setting:
The study will be conducted in Cardiff and Vale University Health Board, with patients drawn from Cardiology clinics and inpatient wards. Follow-up assessments will be conducted at Cardiff School of Sport, a research facility at a university campus close to the main hospital.
Number of subjects planned:
10 patients. This will be sufficient to establish estimates of variability in the diastolic reserve index (see below), allow estimation of treatment difference and gauge acceptability.
Target population:
Subjects with HFpEF and chronotropic incompetence
Endpoints:
Systolic and diastolic longitudinal reserve index are calculated by the following formulae:
Systolic reserve = Δs' x [1-(1/s'rest)] Diastolic reserve = Δe' x [1-(1/e'rest)]
These are known to be impaired in patients with HFpEF and are a marker of adaptation to exercise in terms of filling pressures and left ventricular relaxation. Tan et al report a significant difference between the results seen with 56 patients with HFpEF and 27 control subjects on exercise echocardiography with semi-supine bicycle.16 Patient characteristics were similar to those of our proposed study group (Ejection fraction (EF) >50%, New York Heart Association (NYHA) classification grade II, HFpEF according to Vasan and Levy criteria).28
The investigators will therefore investigate diastolic and systolic reserve index as possible endpoints of a future study into the efficacy of CRT versus RRP in HFpEF patients.
Planned interventions:
Visit 1 - Baseline Assessments: Patients will undergo initial assessment of baseline characteristics by echocardiography, cardiopulmonary exercise testing, 6-minute walk test (6MWT) and Minnesota Living with Heart Failure Questionnaire (MLHFQ). (Visit length: approx. 4 hours)
Visit 2 - Device Implantation (≤ 7 days after baseline assessments completed):
Eligible subjects will undergo implantation of a biventricular pacemaker under normal laboratory conditions. The device will be programme to administer rate-responsive pacing (DDDR). They will return to pacing clinic a week later for a programming check; during this visit, they will also undergo a chest x-ray according to local protocol to ensure correct lead placement (Visit length: 1 day + 2 hours)
Visit 3 - Assessments and Device Reprogramming After 12 weeks, the baseline parameters will be reassessed and patients will then have their device non-invasively reprogrammed to CRT. (Visit length: approx. 4 hours)
Visit 4 - Assessments After a further 12 weeks, the baseline assessments will be repeated. The pacemaker will be non-invasively reprogrammed to DDDR mode and the patient will go home. (Visit length: approx. 4 hours)
Optional extension (pending analysis of results) Visit 5 - Reprogramming If incremental benefit has been demonstrated with CRT above the benefit of RRP, the echocardiograms will be examined to establish the mechanism of improvement. Subjects will be invited to participate in a study extension using multisite technology. The device will be non-invasively reprogrammed to optimise the CRT settings targeted specifically for the mechanism identified. (Visit length: approx. 3 hour)
Visit 6 - Assessments 12 weeks after the final reprogramming, patients will attend for a final set of assessments as per baseline. Participant involvement will then cease. (Visit length: approx. 4 hours)
Total contact time with research team: Approximately 27 hours (22 hours without extension)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Exploratory single-centre, open label, non-randomised, prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| Biventricular Pacemaker | Experimental | Device: Biventricular pacemakerAll subjects to be in a single study group experiencing all interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Confirmed HFpEF as described above
- Chronotropic incompetence as described above
- Ongoing exertional breathlessness of NYHA Grade II or worse
- Ability to understand and sign written consent form
- Males and females, age >18 years
Key exclusion criteria (7 listed)
- Any contraindication to implantation of permanent pacemaker, namely unresolved infective process or sepsis, vascular access difficulties, advanced neoplastic process, expected lifespan less than 1 year or patient choice
- Ejection fraction <50%
- Known valvular disease graded severe or moderate-to-severe
- Cardiac arrhythmia (paroxysmal or persistent) within 1 year of recruitment
- Exertional chest pain suggestive of angina or personal history of coronary artery disease without subsequent revascularisation, or coronary angiogram within the past 5 years demonstrating >50% stenosis in ≥ 1 epicardial coronary artery
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 |
|---|---|---|
| Biventricular pacemakerAlso: Rate responsive pacingAll subjects will receive a biventricular pacemaker at implantation. Programming will initially be to dual-chamber, dual-function rate-responsive pacing for 12 weeks; following reassessment, device will be reprogrammed to biventricular pacing for a further 12 weeks. Optional study extension: if incremental benefit is shown for biventricular pacing above dual chamber, the mechanism will be sought using echocardiographic evidence and the devices will be optimised according to this mechanism of action to see whether further benefit can be achieved. | Device | Biventricular Pacemaker |
Primary outcome
Diastolic reserve index
Time frame: After 12 weeks of rate responsive pacing and again after 12 weeks of biventricular pacing; study extension: after 6 weeks of optimised pacing
The change in e' between rest and exercise, as measured by tissue Doppler in the septal and/or lateral left ventricular walls on echocardiography. To be expressed using the formula: [change in e'] x [1-(1/e' at rest)]. e' is the peak diastolic velocity of the myocardium during passive left ventricular filling.
Systolic reserve index
Time frame: After 12 weeks of rate responsive pacing and again after 12 weeks of biventricular pacing; study extension: after 6 weeks of optimised pacing
The change in s' between rest and exercise, as measured by tissue Doppler in the septal and/or lateral left ventricular walls on echocardiography. To be expressed using the formula: [change in s'] x [1-(1/s' at rest)]. s' is the peak systolic velocity of the myocardium.
8 secondary outcomes
Global longitudinal strain
Time frame: After 12 weeks of rate responsive pacing and again after 12 weeks of biventricular pacing; study extension: after 6 weeks of optimised pacing
Left ventricular torsion
Time frame: After 12 weeks of rate responsive pacing and again after 12 weeks of biventricular pacing; study extension: after 6 weeks of optimised pacing
Exercise duration
Time frame: After 12 weeks of rate responsive pacing and again after 12 weeks of biventricular pacing; study extension: after 6 weeks of optimised pacing
Oxygen carrying capacity
Time frame: After 12 weeks of rate responsive pacing and again after 12 weeks of biventricular pacing; study extension: after 6 weeks of optimised pacing
Distance walked in a six-minute walk test
Time frame: After 12 weeks of rate responsive pacing and again after 12 weeks of biventricular pacing; study extension: after 6 weeks of optimised pacing
New York Heart Association Function Class
Time frame: After 12 weeks of rate responsive pacing and again after 12 weeks of biventricular pacing; study extension: after 6 weeks of optimised pacing
Minnesota Living with Heart Failure Quality of Life Score
Time frame: After 12 weeks of rate responsive pacing and again after 12 weeks of biventricular pacing; study extension: after 6 weeks of optimised pacing
Prognostic biomarkers
Time frame: After 12 weeks of rate responsive pacing and again after 12 weeks of biventricular pacing; study extension: after 6 weeks of optimised pacing
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 2 Jun 2023.
- Individual participant dataSharing planned: No. Access to individual participant data (IPD) will be at the discretion of the study team. No plan is currently in place to share IPD. This is a small, exploratory study where full transparency will be demonstrated in publication of results; fully-anonymised individual participant data may be referenced in publication of results.
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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.
Zaheer Yousef, MD study director
Cardiff and Vale University Health Board
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biventricular pacemaker in people with Diastolic Heart Failure, run by Cardiff and Vale University Health Board at 2 sites 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 7 inclusion and 7 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 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Diastolic reserve index (time frame: After 12 weeks of rate responsive pacing and again after 12 weeks of biventricular pacing; study extension: after 6 weeks of optimised pacing). The study lists 2 primary outcomes in all. 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 2 Jun 2023.