Prehab Prior to Undergoing Tricuspid Intervention

Terminated

• Conditions: Tricuspid Regurgitation; Tricuspid Valve Disease
• Interventions: Other: Prehabilitation

• Registration Number: NCT04665583
• Lead Sponsor: Baylor Research Institute

Brief Summary

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.

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 Timeline

• Study Start: 2020-10-25
• Study First Submitted: 2020-11-23
• Study First Submitted QC: 2020-12-07
• Study First Posted: 2020-12-11
• Primary Completion: 2021-11-01
• Study Completion: 2021-11-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-22
• Last Update Posted: 2022-09-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in volume status according to daily input/outputs	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	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	5 days (Baseline to Day 4 of Prehab)	severity of tricuspid regurgitation (mild, moderate, severe)
Change in Nutritional Status	4 days (Baseline to Day 3 of Prehab)	Pre-albumin (mg/dL)

Trial Locations

Locations (1)

Baylor Scott & White Heart Hospital - Plano; 🇺🇸 Plano, Texas, United States