Daily Life Activities in Patients Treated With Continuous-Flow Left Ventricular Assist Devices (Act-VAD)

Daily Life Activities in Patients Treated With Continuous-Flow Left Ventricular Assist Device

Investigation of oxygen uptake during daily life activities in HF patients with and without LVADs.

Study Overview

• Status: Recruiting
• Conditions: Left Ventricular Failure, Unspecified
• Intervention / Treatment: Other: Measurement of peak oxygen uptake

Detailed Description

In patients with terminal HF the gold standard for treatment is heart transplantation, though the Worldwide shortage of donor organs has led to increased use of implantable mechanical circulatory support devices. The treatment with implantable pumps in the form of a Continuous Flow Left Ventricular Assist Device (CF-LVAD, or simply LVAD) is extremely effective for a selected patient groups leading to significant improvement in survival and quality of life.

The device is a battery-powered flow pump that carries the blood from the left ventricle to the main artery, via a cannula, and thus relieves the failing left ventricle with up to 10 liters of blood per minute. An LVAD can be used both as lifelong support therapy (Destination Therapy, DT) or until transplantation can take place (Bridge therapy).

As patients today live for more than 10 years with the device as DT, the focus has shifted from mere survival to quality of life and physical ability.

In recent years, our research group showed that the pump speed and the patient's baseline heart rhythm (sinus rhythm vs atrial fibrillation) and reduced ability to regulate the intrinsic rhythm after implantation (chronotropic incompetence) are significant contributors to the reduced exercise capacity seen in this patient group.

Until now, studies have elucidated the work capacity of this patient group using a 6-minute walk test or bicycle test - none of these reflect how well the patient actually functions in his everyday life.

In this study, we will describe oxygen uptake related to specific daily activities (ADL-VO2) and compare these with the well-known maximum work capacity (percentage of expected oxygen uptake / pVO2) in this patient group.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kiran K Mirza, MD; Phone Number: +4535451442; Email: KMIR0003@regionh.dk
• Study Contact Backup: Name: Finn Gustafsson, MD, PhD, DMSci; Phone Number: 004535459743; Email: finn.gustafsson@regionh.dk

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

LVADs:

Inclusion Criteria:

• Implanted durable left ventricular assist device
• Age>18yrs
• Signed informed consent

Exclusion Criteria:

• No consent
• Not able to complete VO2 test (physicians decision)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LVAD recipients; Peak oxygen uptake vs VO2 measure during specific daily life activities in LVAD recipients	Other: Measurement of peak oxygen uptake; Oxygen uptake measured on bike (pVO2) and during the conduction of specific daily life activities (ADL-VO2).
Experimental: Healthy controls; Peak oxygen uptake vs VO2 measure during specific daily life activities in healthy controls.	Other: Measurement of peak oxygen uptake; Oxygen uptake measured on bike (pVO2) and during the conduction of specific daily life activities (ADL-VO2).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VO2	Oxygen uptake	Stable LVAD recipients on average 2 years after the implantation

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Principal Investigator: Finn Gustafsson, MD,PhD,DMSci, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: January 27, 2021
• First Submitted That Met QC Criteria: January 27, 2021
• First Posted (Actual): February 1, 2021

Study Record Updates

• Last Update Posted (Actual): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 16, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: quality of life; left ventricular assist device; oxygen uptake; daily life activity
• Other Study ID Numbers: H-20049568

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No