Prehab Prior to Undergoing Tricuspid Intervention

Single-Center, Prospective, Open-Label Study Standardizing a Prehabilitation Protocol to Optimize Patients Prior to Undergoing Tricuspid Intervention

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.

Study Overview

• Status: Terminated
• Conditions: Tricuspid Regurgitation; Tricuspid Valve Disease
• Intervention / Treatment: Other: Prehabilitation

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

• Study Type: Observational
• Enrollment (Actual): 9

Contacts and Locations

Study Locations

• United States
  • Texas
    • Plano, Texas, United States, 75093
      • Baylor Scott & White Heart Hospital - Plano

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

40 adult male or female patients undergoing tricuspid valve intervention at The Heart Hospital Baylor Plano

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Baylor Research Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2020
• Primary Completion (Actual): November 1, 2021
• Study Completion (Actual): November 1, 2021

Study Registration Dates

• First Submitted: November 23, 2020
• First Submitted That Met QC Criteria: December 7, 2020
• First Posted (Actual): December 11, 2020

Study Record Updates

• Last Update Posted (Actual): September 23, 2022
• Last Update Submitted That Met QC Criteria: September 22, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: 020-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: We do not have a plan to shared IPD to researchers outside of our research team. We will make available aggregate data and results in the form of publications. Internal BSWH monitors will have access to IPD.

Drug and device information, study documents

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