PROTECT-UP: Physiological Versus Right Ventricular Outcome Trial Evaluated for Bradycardia Treatment Upgrades
Study Details
Study Description
Brief Summary
Guidelines for patients having first-time implants advocate that even when heart function is only mildly impaired, modern pacing approaches should be utilised to avoid the potentially damaging effects of RV pacing to preventing symptoms from pacing induced or worsened cardiomyopathy.
However, once a traditional (RV) pacemaker is implanted, development of impaired heart function does not prompt a device upgrade. Even at the end of battery life, physicians simply replace it like-for-like.
This trial tests whether such patients have better symptoms and quality of life if changed to a modern physiological pacing strategy from the traditional RV pacing approach.
In this crossover trial, participants will be upgraded to a physiological pacing strategy.
After their procedure, they will have a one-month run-in period to recover from the procedure (their pacemaker will be programmed to continued RV pacing).
They will be have 2 one-month blinded time periods, randomised to physiological pacing or right ventricular pacing alternately. They will subsequently undergo two six-month blinded randomised time periods.
Patients will document symptoms monthly on a mobile phone application or computer. At the end of each time period, they will have measurements of heart function, a walking test and quality-of-life questionnaires including the SF-36 questionnaire.
The investigators hypothesise that upgrading to physiological pacing strategies will improve patients' quality of life.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Physiological Pacing (Conduction System Pacing or Biventricular Pacing) The approach for physiological pacing will be either His bundle pacing or left bundle pacing at the operator's discretion. If both of these are not achieved biventricular pacing will be performed. |
Device: Physiological Pacing Upgrade (Conduction System Pacing or Biventricular Pacing)
The approach for physiological pacing upgrade will be either His bundle pacing or left bundle pacing at the operator's discretion. If both of these are not achieved biventricular pacing will be performed.
|
| Active Comparator: Right Ventricular Pacing Right ventricular pacing (apical or septal lead locations as per the implanting physicians' normal practice) |
Device: Continued RV Pacing (Right Ventricular Pacing)
Right ventricular pacing (apical or septal lead locations as per the implanting physicians' normal practice).
|
Outcome Measures
Primary Outcome Measures
- SF-36 (Short Form 36 Health Survey Questionnaire) Physical Component Summary [From date of baseline, until end of trial follow-up at fourteen months post-baseline]
Secondary Outcome Measures
- Left ventricular ejection fraction [From date of baseline, until end of trial follow-up at fourteen months]
(% ejection fraction)
- Left ventricular end systolic volume [From date of baseline, until end of trial follow-up at fourteen months]
(millilitres)
- Minnesota Living with Heart Failure Questionnaire [From date of baseline, until end of trial follow-up at fourteen months]
- Six-minute walk test [From date of baseline, until end of trial follow-up at fourteen months]
Measured in distance in metres
- Atrial fibrillation [From date of baseline, until end of trial follow-up at fourteen months]
(atrial fibrillation percentage burden as measured by pacemaker device - %)
- Patient preference based on blinded symptomatic preference [At 2 months following baseline and 14 months following baseline visit]
- EQ-5D Questionnaire [From date of baseline, until end of trial follow-up at fourteen months post-baseline visit]
EQ-5D is the name of the instrument and is not an acronym. The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ 'visual analogue scale' (EQ VAS). The descriptive system is made up of 5 sections: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative (numerical) measure of health outcome that reflect the patient's own judgement. A high score on the VAS means a better outcome. A low score on the VAS means a worse outcome.
- Patient symptoms assessed on a scale of 0-100 monthly [From date of baseline, until end of trial follow-up at fourteen months post-baseline visit]
This questionnaire will be sent to participants on a monthly basis for the duration of the study
- Safety endpoints [From device implant date, assessed up to 15 months at the end of the trial (including a one-month run-in period post-procedure prior to the first baseline visit)]
Device infections (requiring device extraction), pacing thresholds, need for lead revision or reimplantation, generator change, haematoma and pneumothorax
- SF-36 (Short Form 36 Health Survey Questionnaire) Overall Score [From date of baseline, until end of trial follow-up at fourteen months post baseline visit]
- SF-36 (Short Form 36 Health Survey Questionnaire) Individual Component Scores [From date of baseline, until end of trial follow-up at fourteen months post baseline visit]
- BNP (B-type natriuretic peptide) [From date of baseline, until end of trial follow-up at fourteen months post baseline visit]
B-type natriuretic peptide blood test
Eligibility Criteria
Criteria
Patients with an RV pacemaker and LVEF 35-50% who are clinically indicated for a cardiac resynchronisation therapy upgrade procedure and:
-
EF reduced by >5% of increase in LVESV by 10ml since implant
-
NT-proBNP >250ng/L in sinus rhythm
-
NT-proBNP > 750 Ng/L if AF
-
Left atrial volume index > 30ml/m2
-
Regular loop diuretics prescribed
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Decline in daily patient activity by >1 hour per day since implant
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Decrease in device measured thoracic impedance
-
Patient reported decline in functional class or exercise tolerance
Exclusion Criteria:
-
Those unable to provide informed consent
-
Patients under age 18
-
Pregnant women
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hammersmith Hospital | London | United Kingdom |
Sponsors and Collaborators
- Imperial College London
Investigators
- Principal Investigator: Daniel Keene, PhD, Imperial College London
- Study Director: Nandita Kaza, MRCP, Imperial College London
- Study Director: Matthew Shun-Shin, PhD, Imperial College London
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 23HH8156