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

May 29, 2020 updated by: Finn Gustafsson

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • DK
      • Copenhagen, DK, Denmark, 2100
        • Recruiting
        • Rigshospitalet
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Peak oxygen uptake test with pacing
Other: Peak oxygen uptake test with pacing
Peak oxygen uptake test with paced heart rate
Other Names:
  • 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 Names:
  • Sham pacing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Peak oxygen uptake (pVO2)
Time Frame: 1 Day
1 Day

Secondary Outcome Measures

Outcome Measure
Time Frame
Heart rate
Time Frame: 1 Day
1 Day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Finn Gustafsson

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 23, 2019

Primary Completion (ANTICIPATED)

January 31, 2021

Study Completion (ANTICIPATED)

January 31, 2021

Study Registration Dates

First Submitted

February 15, 2019

First Submitted That Met QC Criteria

February 15, 2019

First Posted (ACTUAL)

February 18, 2019

Study Record Updates

Last Update Posted (ACTUAL)

June 2, 2020

Last Update Submitted That Met QC Criteria

May 29, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H-17029488

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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