Pacing in Left Ventricular Assist Device Recipients

Study Overview
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Brief Summary
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Implantation with left ventricular assist device (LVAD) in patients with end-stage heart failure (HF) leads to improvements in survival and quality of life, however, work capacity remains disappointingly low, at half of the expected value. Complex central and peripheral hallmarks of heart failure attribute to the continued work intolerance, to which heart rate may be a contributing factor. The purpose of this study is to clarify the impact of heart rate (by means of pacing) on work capacity (measured as peak oxygen uptake) in LVAD recipients.

Detailed Description
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While implantation with left ventricular assist devices (LVADs) in patients with end-stage heart failure (HF) improve survival and quality of life, work capacity remains at a disappointing 50% of the expected value. Due to the worldwide (increasing) shortage of donor hearts, LVADs are increasingly used as destination therapy which makes it crucial for physicians to persistently identify opportunities to improve management, lower the adverse events and maximize the benefits of this treatment option. In recent years it was found that upregulation of device pump speed improves the maximal work capacity of LVAD recipients with no side effects. More recently it was found that the patients' heart rate reserve also was of importance in this regard, however, the latter was shown in a retrospective study and needs to be confirmed in a prospective randomized double-blinded intervention study. As a large portion of LVAD recipients are already implanted with a pacing device (and suffer from chronotropic incompetence) such a study is possible to conduct by controlling their heart rate during exercise by pacing (ie randomized crossover design).

Official Title
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Work Intolerance in Left Ventricular Assist Device Recipients: Impact of Pacing

Conditions
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Heart Rate, Chronotropic Incompetence, Pacing

Intervention / Treatment
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* Other: Peak oxygen uptake test with pacing
* Other: Peak oxygen uptake test without pacing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Implanted with a left ventricular assist device Implanted with a pace-device ensuring the possibility of pacing Age > 18 Exclusion Criteria: Not able to undergo a peak oxygen uptake test No consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Peak oxygen uptake test with pacing<br>Peak oxygen uptake test with pacing | Other: Peak oxygen uptake test with pacing<br>* Peak oxygen uptake test with paced heart rate<br>* Other names: Regulation of pace-device;|
| Sham Comparator: Peak oxygen uptake test without pacing<br>Peak VO2 test without pacing | Other: Peak oxygen uptake test without pacing<br>* Peak oxygen uptake test without paced heart rate<br>* Other names: Sham pacing;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak oxygen uptake (pVO2) |  | 1 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate |  | 1 Day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronotropic incompetence, pacing, heart rate, exercise, peak oxygen uptake