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

NCT04205760 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-05-26

No results posted yet for this study

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). 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.

Conditions

  • Left Ventricular Assist Device
  • End-stage Heart Failure
  • Cardiac Surgery

Interventions

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.

Sponsors & Collaborators

  • RWTH Aachen University

    lead OTHER

Principal Investigators

  • Christian Stoppe, Prof. Dr. med. · RWTH Aachen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-02
Primary Completion
2023-07-02
Completion
2023-12-02

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04205760 on ClinicalTrials.gov