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Pacing in Left Ventricular Assist Device Recipients (Pace-VAD)

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ClinicalTrials.gov Identifier: NCT03844516
Recruitment Status : Recruiting
First Posted : February 18, 2019
Last Update Posted : June 2, 2020
Sponsor:
Information provided by (Responsible Party):
Finn Gustafsson, Rigshospitalet, Denmark

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Heart Rate Chronotropic Incompetence Pacing Other: Peak oxygen uptake test with pacing Other: Peak oxygen uptake test without pacing Not Applicable

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Masking Description:

Patients and staff performing the peak oxygen uptake test (pVO2) will be blinded to device regulation. Blinding will be ensured by recruiting a secondary doctor or other staff to regulate pace-settings in relation to the paced pVO2 test while performing sham regulations (or just read pace-settings) in relation to the non-paced pVO2 test.

Thus, both patients and investigator are blinded.
Primary Purpose: Supportive Care
Official Title: Work Intolerance in Left Ventricular Assist Device Recipients: Impact of Pacing
Actual Study Start Date : April 23, 2019
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arms and Interventions
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Arm Intervention/treatment
Peak oxygen uptake test with pacing
Peak oxygen uptake test with pacing
 Other: Peak oxygen uptake test with pacing
Peak oxygen uptake test with paced heart rate
Other Name: Regulation of pace-device
Sham Comparator: Peak oxygen uptake test without pacing
Peak VO2 test without pacing
 Other: Peak oxygen uptake test without pacing
Peak oxygen uptake test without paced heart rate
Other Name: Sham pacing


Outcome Measures
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Primary Outcome Measures :
  1. Peak oxygen uptake (pVO2) [ Time Frame: 1 Day ]

Secondary Outcome Measures :
  1. Heart rate [ Time Frame: 1 Day ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03844516


Contacts
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Contact: Finn Gustafsson, MD, PhD, DMSc. 34459743 FinnG@dadlnet.dk

Locations
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Denmark
Rigshospitalet Recruiting
Copenhagen, DK, Denmark, 2100
Contact: Finn Gustafsson, MD, PhD, DMSc    35459743    FinnG@dadlnet.dk   
Sponsors and Collaborators
Finn Gustafsson
More Information
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Responsible Party: Finn Gustafsson, Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03844516    
Other Study ID Numbers: H-17029488
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: June 2, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Finn Gustafsson, Rigshospitalet, Denmark:
Chronotropic incompetence
pacing
heart rate
exercise
peak oxygen uptake