Clinical trial NCT04665583: Prehab Prior to Undergoing Tricuspid Intervention
Official title: Single-Center, Prospective, Open-Label Study Standardizing a Prehabilitation Protocol to Optimize Patients Prior to Undergoing Tricuspid Intervention
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Tricuspid Valve Disease
Tricuspid Regurgitation
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 40 adult male or female patients undergoing tricuspid valve intervention at The Heart Hospital Baylor Plano

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in volume status according to daily input/outputs
timeFrame: 4-5 days (Day 1 to Day 4 of Prehab or day of surgical intervention)
measure: Change in volume status according to weight
timeFrame: 5-6 days (Baseline to Day 4 of Prehab or day of surgical intervention)
measure: Change in Severity of Tricuspid Regurgitation by Echocardiographic assessment
timeFrame: 5 days (Baseline to Day 4 of Prehab)
measure: Change in Nutritional Status
timeFrame: 4 days (Baseline to Day 3 of Prehab)
Secondary outcomes:
Other outcomes:
Locations:
city: Plano
country: United States
facility: Baylor Scott & White Heart Hospital - Plano
state: Texas
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.