Preoperative Nutritional Optimization and Physical Exercise for Patients Scheduled for Elective Implantation for a Left-Ventricular Assist Device (PROPER-LVAD)

This is a pilot, randomized, multicenter interventional trial of a combined preoperative oral nutritional support (ONS) and physical exercise therapy in patients planned for elective implantation of a left-ventricular assist device (LVAD). This pilot study pursues to demonstrate the feasibility and safety of a study protocol to optimize the patients' nutritional and physical state to reduce the number of postoperative complications and consequently to ameliorate the patients' outcome.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Surgery; Left Ventricular Assist Device; End-stage Heart Failure
• Intervention / Treatment: Combination product: Nutrition + exercise

Detailed Description

The oral nutrition supplementation will be started immediately after randomization and will be continued until surgery. The patients will receive a dosage of ONS adjusted to their nutritional risk. Regular monitoring of blood sugars, electrolytes, phosphate, and triglycerides will occur twice per week, as per standard protocol.

In-bed cycling will be started as soon as possible after randomization. Cycling sessions will be performed daily for 50 minutes, at least 5 times a week until surgery. Standard safety criteria will be assessed prior to initiating cycling treatments. The in-bed cycling will be performed passively or actively with graded increasing resistance. All cycling interventions will be performed under 1:1 supervision of medically trained study personnel while monitoring patient's heart rate, systolic and diastolic blood pressure and transcutaneous oxygen saturation of blood.

When evaluating the effect of a combined nutritional and exercise intervention, other important co-interventions should be standardized to reduce potential confounding of trial outcomes. All study patients should be fed with an oral diet that is in accordance to local standards, whereas it is strongly recommended to adhere to current clinical practice guidelines. Besides, the investigators highly encourage daily respiratory therapy in both groups plus mobilization as much as feasible.

All other key interventions during preoperative treatment will be standardized in accordance to the local clinical practice. Study teams will follow up on the patients on a daily base, documenting adherence with study interventions and key co-interventions.

Patients in the control group will not receive preoperative ONS. No bed cycling will be allowed from admission until surgery. Neither of these practices are the current standard of care in the participating unit.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Aileen Hill, Dr. med.; Phone Number: 38166 +49 241 80; Email: ahill@ukaachen.de
• Study Contact Backup: Name: Elena Laaf, MSc; Phone Number: 89021 +49 241 80; Email: elaaf@ukaachen.de

Study Locations

• Germany
  • Aachen, Germany
    • Recruiting
    • RWTH Aachen University
    • Contact: Aileen Hill, Dr. med.
    • Contact: Elena Laaf, MSc
  • Dresden, Germany
    • Not yet recruiting
    • Heart Center Dresden
    • Contact: Klaus Matschke, Univ.-Prof. Dr. med. habil.
  • Giessen, Germany
    • Not yet recruiting
    • University Hospital Justus-Liebig University Giessen
    • Contact: Bernd Niemann, PD Dr. med.
  • Kiel, Germany
    • Not yet recruiting
    • University Medical Center Schleswig-Holstein, Campus Kiel
    • Contact: Bernd Panholzer, Dr. med.
  • NRW
    • Bad Oeynhausen, NRW, Germany
      • Recruiting
      • Heart Center Bad Oeynhausen
      • Contact: Vera von Dossow

Participation Criteria

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:

1. Given informed consent
2. Adult patients (≥18 years)
3. Patients undergoing elective LVAD implantation Additional cardiac surgery, such as bypass grafting, or valve repair is permitted

Exclusion Criteria:

1. Hospital admission <5 days prior to planned LVAD implantation
2. Patients on ECMO or INTERMACS<1
3. Patients already receiving nutrition support on hospital admission
4. Enteral nutrition is contraindicated.
5. Pregnant or lactating patients
6. Patients with clinical fulminant hepatic failure
7. Patients with cirrhosis Child's Class C Liver Disease
8. Patients with clinical kidney failure or requiring hemodialysis
9. Known allergy or intolerance to study nutrients
10. Intracranial or spinal process affecting motor function
11. Lower extremity impairments that prevent cycling
12. Disabling neuropsychiatric disorders or language barriers
13. Weight > 150 kg
14. Enrolment in an industry sponsored randomized trial within the last 30 days (co-enrolment in academic randomized trials will be considered on a case by case basis)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Standard Care as per local guidelines
Experimental: Intervention; Oral nutrition support (ONS) and bed-cycling before surgery	Combination product: Nutrition + exercise; Patients will receive preoperative optimization consisting of oral nutrition support (Fresubin 3.2 kcal) and bed-cycling (50 minutes per day) for 5-14 days before surgery.; Other Names: ONS; bed cycling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of adverse events	adverse events between groups related to cycling and nutritional complications	up to 2 weeks before surgery
Separation of caloric supplementation	Separation between groups on prescribed caloric targets	up to 2 weeks before surgery
Separation of protein supplementation	Separation between groups on prescribed protein targets	up to 2 weeks before surgery
Proportion of interventions received as prescribed	Proportion of interventions received as prescribed	up to 2 weeks before surgery
Rate of patients recruited per month	Target: 1.5 patients per month	up to 18 months
Ratio of control patients received physiotherapy	Ratio of control patients received physiotherapy	up to 2 weeks before surgery
Ratio of control patients received nutritional support	Ratio of control patients received nutritional support	up to 2 weeks before surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality rates at day 30	mortality rates at day 30	day 30 after randomization
rates of ICU length of stay	rates of ICU length of stay	up to 3 months
rates of hospital length of stay	rates of hospital length of stay	up to 3 months
Mean duration of mechanical ventilation	Mean duration of mechanical ventilation	up to 3 months
Incidence of complications	Incidence of complications	up to 3 months
Incidence of infections	Incidence of infections	up to 3 months
Change in Mid-arm circumference	baseline values versus follow-up values	up to 6 months
Change in Muscle mass - Quadriceps thickness	ultrasound, baseline values versus follow-up values	up to 6 months
Change in Muscle mass - Quadriceps cross sectional area	ultrasound, baseline values versus follow-up values	up to 6 months
Change in Muscle strength - Handgrip strength	Dynamometry, baseline values versus follow-up values	up to 6 months
Change in Muscle strength - Quadriceps strength	Dynamometry, baseline values versus follow-up values	up to 6 months
Change of Clinical Frailty score (CFS)	baseline values versus follow-up values; Score: 1-9 (very fit: 1, terminally ill: 9)	up to 6 months
Change in Physical function - 6-Minute Walk Test	baseline values versus follow-up values, 6-minute walking distance	up to 6 months
Change in Physical function - Short Physical Performance Battery	baseline values versus follow-up values,(Score: 0-12; 0=worst performance and 12=best performance)	up to 6 months
Change in Physical function - Functional Status Score for the ICU	baseline values versus follow-up values,(Score 0-35; the higher the score, the better physical functioning)	up to 6 months
Change in quality of life - Lawton Instrumental Activities of Daily Living (IADL)	baseline values versus follow-up values, (score 0-8; the higher the more independent)	up to 6 months
Change in quality of life - Katz Activities of Daily Living (ADL)	baseline values versus follow-up values,(Score: 0-100; the higher the more independent)	up to 6 months
Quality of life - Short Form 36 (SF-36)	baseline values versus follow-up values,(Score: 0-100; 100=no limitation in daily life and 0=completely limited)	up to 6 months
Change in neurological function - Mini Mental State Examination	baseline values versus follow-up values, (score: 0-30; the higher the less cognitively impaired)	up to 6 months

Collaborators and Investigators

• Sponsor: RWTH Aachen University
• Investigators: Principal Investigator: Christian Stoppe, Prof. Dr. med., RWTH Aachen University

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2022
• Primary Completion (Anticipated): July 2, 2023
• Study Completion (Anticipated): December 2, 2023

Study Registration Dates

• First Submitted: December 18, 2019
• First Submitted That Met QC Criteria: December 18, 2019
• First Posted (Actual): December 19, 2019

Study Record Updates

• Last Update Posted (Actual): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 25, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: cardiac surgery; exercise; cycling; nutrition therapy; LVAD; preoperative optimization; end-stage heart failure
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 19-136

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No