Pacing in Left Ventricular Assist Device Recipients

Heart Rate Clinical Trial

— Pace-VAD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03844516
• Other study ID #: H-17029488
• Status: Recruiting
• Phase: N/A
• Start date: April 23, 2019
• Est. completion date: January 31, 2021

Study information

• Verified date: May 2020
• Source: Rigshospitalet, Denmark
• Contact: Finn Gustafsson, MD, PhD, DMSc.
• Phone: 34459743
• Email: FinnG[@]dadlnet.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronotropic Incompetence
• Heart Rate
• Pacing

Intervention

Other:
• Peak oxygen uptake test with pacing
Peak oxygen uptake test with paced heart rate
• Peak oxygen uptake test without pacing
Peak oxygen uptake test without paced heart rate

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen	DK

Sponsors (1)

Lead Sponsor	Collaborator
Finn Gustafsson

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak oxygen uptake (pVO2)		1 Day
Secondary	Heart rate		1 Day