Prehab Prior to Undergoing Tricuspid Intervention

NCT04665583 | Terminated

• 1 other identifier: 020-101
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Tricuspid Valve Disease; Tricuspid Regurgitation

Outcome Measures

Primary Outcomes (4)

• 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)

Study Arms (1)

Prehabilitation

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

Other: Prehabilitation

Interventions

Prehabilitation OTHER

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.

Prehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• ≥ 18 years of age
• Moderate-Severe or Severe TR
• Undergoing tricuspid valve surgical or catheter-based intervention

You may not qualify if:

• \. Clinical instability according to the judgement of the Investigator

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor Scott & White Heart Hospital - Plano

Plano, Texas, 75093, United States

Location

Related Publications (3)

• 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.

  PMID: 29241483 BACKGROUND

• 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.

  PMID: 30951698 BACKGROUND

• 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.

  PMID: 31805294 BACKGROUND

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 11, 2020
• Study Start: October 25, 2020
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: September 23, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)