Prehab Prior to Undergoing Tricuspid Intervention

Overview

This study will aim to standardize the prehabilitation protocol to optimize patients and document the clinical and echo variables that could improve clinical outcomes of tricuspid valve intervention.

Full Title of Study: “Single-Center, Prospective, Open-Label Study Standardizing a Prehabilitation Protocol to Optimize Patients Prior to Undergoing Tricuspid Intervention”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 2021

Detailed Description

Prior to screening activities, each subject will be given an opportunity to ask questions and to understand the details of study participation. Subjects who meet the inclusion and exclusion criteria and have signed an informed consent form will be considered enrolled into the study. After a subject is consented and enrolled in the study, data will be collected prior to any intervention or surgery at the following time points: a) Screening/Baseline b) Day 1 of Prehab c) Day 2 of Prehab d) Day 3 of Prehab e) Day 4 of Prehab, f) and any data collected immediately prior to an intervention or incision (in the case of a surgical patient) Subjects meeting eligibility criteria with planned tricuspid intervention will receive in-hospital optimization with THHBP's Prehab Protocol. Prehabilitation will consist of careful pre-intervention assessment and personalized optimization, guided by Investigator judgment, with a specific focus on right ventricular function. This will be done by using a detailed echo acquisition protocol (Appendix 1). Assessments will be collected according to the schedule of events below (Table 1.). Therapy will include intravenous milrinone therapy and aggressive diuresis with evaluation for clinical and functional signs of improvement, according to standard of care. If there are clinical and functional signs of improvement before Day 4, and the subject is ready for TV surgery or any other intervention, they will have Day 4 procedures performed. After the tests and evaluations are completed, the Principal Investigator or Sub-Investigators will decide if the patient is a candidate for TV surgery or another intervention

Interventions

  • Other: Prehabilitation
    • Prehabilitation will consist of careful pre-intervention assessment and personalized optimization, guided by Investigator judgment, with a specific focus on right ventricular function. This will be done by using a detailed echo acquisition protocol (Appendix 1). Assessments will be collected according to the schedule of events below (Table 1.). Therapy will include intravenous milrinone therapy and aggressive diuresis with evaluation for clinical and functional signs of improvement, according to standard of care.

Arms, Groups and Cohorts

  • Prehabilitation
    • All study patients will receive preoperative optimization with a standardized prehabilitation protocol prior to any intervention.

Clinical Trial Outcome Measures

Primary Measures

  • Change in volume status according to daily input/outputs
    • Time Frame: 4-5 days (Day 1 to Day 4 of Prehab or day of surgical intervention)
    • daily input/outputs (mL)
  • Change in volume status according to weight
    • Time Frame: 5-6 days (Baseline to Day 4 of Prehab or day of surgical intervention)
    • daily weights (kg)
  • Change in Severity of Tricuspid Regurgitation by Echocardiographic assessment
    • Time Frame: 5 days (Baseline to Day 4 of Prehab)
    • severity of tricuspid regurgitation (mild, moderate, severe)
  • Change in Nutritional Status
    • Time Frame: 4 days (Baseline to Day 3 of Prehab)
    • Pre-albumin (mg/dL)

Participating in This Clinical Trial

Inclusion Criteria

1. ≥ 18 years of age 2. Moderate-Severe or Severe TR 3. Undergoing tricuspid valve surgical or catheter-based intervention Exclusion Criteria:

1. Clinical instability according to the judgement of the Investigator

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Baylor Research Institute
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Sarah M Hale, BA, 4698144845, sarah.hale@bswhealth.org

References

Zack CJ, Fender EA, Chandrashekar P, Reddy YNV, Bennett CE, Stulak JM, Miller VM, Nishimura RA. National Trends and Outcomes in Isolated Tricuspid Valve Surgery. J Am Coll Cardiol. 2017 Dec 19;70(24):2953-2960. doi: 10.1016/j.jacc.2017.10.039.

Hamandi M, Smith RL, Ryan WH, Grayburn PA, Vasudevan A, George TJ, DiMaio JM, Hutcheson KA, Brinkman W, Szerlip M, Moore DO, Mack MJ. Outcomes of Isolated Tricuspid Valve Surgery Have Improved in the Modern Era. Ann Thorac Surg. 2019 Jul;108(1):11-15. doi: 10.1016/j.athoracsur.2019.03.004. Epub 2019 Apr 2.

Hamandi M, George TJ, Smith RL, Mack MJ. Current outcomes of tricuspid valve surgery. Prog Cardiovasc Dis. 2019 Nov – Dec;62(6):463-466. doi: 10.1016/j.pcad.2019.11.014. Epub 2019 Dec 2. Review.

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