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Left Ventricular Assist DevicePhase 3PROPER-LVADNCT04205760

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

A Phase 3 study testing Nutrition + exercise in people with Left Ventricular Assist Device and End-stage Heart Failure, run by RWTH Aachen University at 5 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nutrition + exercise
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
5 sitesGermany
Study dates
2 Jan 2022to 2 Dec 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Hospital admission <5 days prior to planned LVAD implantation
  • Patients on ECMO or INTERMACS<1
  • Patients already receiving nutrition support on hospital admission
  • Enteral nutrition is contraindicated.
  • Pregnant or lactating patients
  • Patients with clinical fulminant hepatic failure
Show all 14Show fewer
  • Patients with cirrhosis Child's Class C Liver Disease
  • Patients with clinical kidney failure or requiring hemodialysis
  • Known allergy or intolerance to study nutrients
  • Intracranial or spinal process affecting motor function
  • Lower extremity impairments that prevent cycling
  • Disabling neuropsychiatric disorders or language barriers
  • Weight > 150 kg
  • 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)

Trial locations and contacts

5 sites in 1 country.

Aileen Hill, Dr. med. contact

+49 241 80 ext. 38166

ahill@ukaachen.de

Elena Laaf, MSc contact

+49 241 80 ext. 89021

elaaf@ukaachen.de

5 sites in 1 country

Germany5 sites, 5 recruiting

  • RWTH Aachen University

    Aachen

    Aileen Hill, Dr. med.

    Elena Laaf, MSc

    Recruiting

  • Heart Center Bad Oeynhausen

    Bad Oeynhausen, North Rhine-Westphalia

    Vera von Dossow

    Recruiting

  • Heart Center Dresden

    Dresden

    Klaus Matschke, Univ.-Prof. Dr. med. habil.

    Not yet recruiting

  • University Hospital Justus-Liebig University Giessen

    Giessen

    Bernd Niemann, PD Dr. med.

    Not yet recruiting

  • University Medical Center Schleswig-Holstein, Campus Kiel

    Kiel

    Bernd Panholzer, Dr. med.

    Not yet recruiting

Other trials in Germany

About this study

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.

Read the 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.

Being tested
Nutrition + exercise
Keywords
LVAD, preoperative optimization, end-stage heart failure, cardiac surgery, nutrition therapy, exercise, cycling
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nutrition + exerciseCombination product

    Also called bed cycling, ONS

    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.

Study groups in NCT04205760
Study groupRoleWhat they receive
Control groupNo interventionStandard Care as per local guidelines
InterventionExperimentalOral nutrition support (ONS) and bed-cycling before surgery
Receives: Combination Product: Nutrition + exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comparison of adverse events

    adverse events between groups related to cycling and nutritional complications

    Measured: up to 2 weeks before surgery

  2. Separation of caloric supplementation

    Separation between groups on prescribed caloric targets

    Measured: up to 2 weeks before surgery

  3. Separation of protein supplementation

    Separation between groups on prescribed protein targets

    Measured: up to 2 weeks before surgery

  4. Proportion of interventions received as prescribed

    Proportion of interventions received as prescribed

    Measured: up to 2 weeks before surgery

  5. Rate of patients recruited per month

    Target: 1.5 patients per month

    Measured: up to 18 months

  6. Ratio of control patients received physiotherapy

    Ratio of control patients received physiotherapy

    Measured: up to 2 weeks before surgery

  7. Ratio of control patients received nutritional support

    Ratio of control patients received nutritional support

    Measured: up to 2 weeks before surgery

Secondary outcomes (19)

  1. mortality rates at day 30

    mortality rates at day 30

    Measured: day 30 after randomization

  2. rates of ICU length of stay

    rates of ICU length of stay

    Measured: up to 3 months

  3. rates of hospital length of stay

    rates of hospital length of stay

    Measured: up to 3 months

  4. Mean duration of mechanical ventilation

    Mean duration of mechanical ventilation

    Measured: up to 3 months

  5. Incidence of complications

    Incidence of complications

    Measured: up to 3 months

  6. Incidence of infections

    Incidence of infections

    Measured: up to 3 months

  7. Change in Mid-arm circumference

    baseline values versus follow-up values

    Measured: up to 6 months

  8. Change in Muscle mass - Quadriceps thickness

    ultrasound, baseline values versus follow-up values

    Measured: up to 6 months

  9. Change in Muscle mass - Quadriceps cross sectional area

    ultrasound, baseline values versus follow-up values

    Measured: up to 6 months

  10. Change in Muscle strength - Handgrip strength

    Dynamometry, baseline values versus follow-up values

    Measured: up to 6 months

  11. Change in Muscle strength - Quadriceps strength

    Dynamometry, baseline values versus follow-up values

    Measured: up to 6 months

  12. Change of Clinical Frailty score (CFS)

    baseline values versus follow-up values; Score: 1-9 (very fit: 1, terminally ill: 9)

    Measured: up to 6 months

  13. Change in Physical function - 6-Minute Walk Test

    baseline values versus follow-up values, 6-minute walking distance

    Measured: up to 6 months

  14. Change in Physical function - Short Physical Performance Battery

    baseline values versus follow-up values,(Score: 0-12; 0=worst performance and 12=best performance)

    Measured: up to 6 months

  15. 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)

    Measured: up to 6 months

  16. 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)

    Measured: up to 6 months

  17. 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)

    Measured: up to 6 months

  18. 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)

    Measured: up to 6 months

  19. Change in neurological function - Mini Mental State Examination

    baseline values versus follow-up values, (score: 0-30; the higher the less cognitively impaired)

    Measured: up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2019
  2. Study start2 Jan 2022
  3. Primary completion2 Jul 2023 (estimated)
  4. Study completion2 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
National multicenter two-group randomized-controlled, blinded to assessor clinical pilot trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04205760
Sponsor's protocol ID
19-136
Acronym
PROPER-LVAD
Status last verified
May 2022
First submitted
18 Dec 2019
Last updated
26 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nutrition + exercise in people with Left Ventricular Assist Device and End-stage Heart Failure, run by RWTH Aachen University at 5 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Aileen Hill, Dr. med. (+49 241 80 ext. 38166, ahill@ukaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of adverse events (time frame: up to 2 weeks before surgery). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04205760.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2022.

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