NCT03844516

Pacing in Left Ventricular Assist Device Recipients

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Finn Gustafsson · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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).

Conditions

• Heart Rate
• Chronotropic Incompetence
• Pacing

Interventions

Type	Name	Description
OTHER	Peak oxygen uptake test with pacing	Peak oxygen uptake test with paced heart rate
OTHER	Peak oxygen uptake test without pacing	Peak oxygen uptake test without paced heart rate

Timeline

• Start date: 2019-04-23
• Primary completion: 2021-01-31
• Completion: 2021-01-31
• First posted: 2019-02-18
• Last updated: 2020-06-02

Locations

1 site across 1 country: Denmark