Cardiac Rehab for Advanced Heart Failure-LVAD Candidates

Heart Failure Clinical Trial

Official title:

A Prospective Trial to Evaluate the Utility of Focused Frailty Interventions on Patients Undergoing Evaluation for Left Ventricular Assist Device (LVAD) Placement

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03132441
• Other study ID #: 17-000210
• Status: Withdrawn
• Phase: N/A
• Start date: April 2017
• Est. completion date: February 2018

Study information

• Verified date: June 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a pilot study evaluating the feasibility and early efficacy of cardiac rehabilitation to improve frailty and symptoms in patients with advanced heart failure (NYHA class III-IV), who are being considered for LVAD therapy.

Description:

Frailty in patients with advanced heart failure is not thoroughly described, but in those studies that assessed frailty, it was a common phenomenon. Furthermore, some data suggest an association between pre-LVAD implant frailty and post-implant complications and survival. Interventions for frailty have been utilized in various populations, including the elderly frail and the frail from cardiovascular causes. These interventions target physical strengthening and endurance and have been shown on occasion to improve functional outcomes. The current study, a pilot study, seeks to assess frailty in a prospective cohort of patients being evaluated in Heart Failure Clinic for consideration of LVAD implantation due to NYHA class III-IV dyspnea and enroll these patients in a six-week focused cardiac rehabilitation protocol aimed at improving frailty and functional independence. The primary endpoint of the study is improvement in frailty markers at the end (gait speed, handgrip strength), and secondary endpoints include improvement in the indices of quality of life and symptomatology via validated questionnaires.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Candidate for a Left Ventricular Assist Device (LVAD)

• Advanced Heart Failure as determined by New York Heart Association classification III or IV

Exclusion Criteria:

• Unable to perform physical activities required by protocol due to anatomic or musculoskeletal comorbidities

• Physical activity is contraindicated

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Strength Training for Frailty
Cardiac Rehabilitation, abbreviated course

Locations

Country	Name	City	State
United States	Mayo Clinic-Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (6)

Chung CJ, Wu C, Jones M, Kato TS, Dam TT, Givens RC, Templeton DL, Maurer MS, Naka Y, Takayama H, Mancini DM, Schulze PC. Reduced handgrip strength as a marker of frailty predicts clinical outcomes in patients with heart failure undergoing ventricular assist device placement. J Card Fail. 2014 May;20(5):310-5. doi: 10.1016/j.cardfail.2014.02.008. Epub 2014 Feb 22. — View Citation

Dunlay SM, Park SJ, Joyce LD, Daly RC, Stulak JM, McNallan SM, Roger VL, Kushwaha SS. Frailty and outcomes after implantation of left ventricular assist device as destination therapy. J Heart Lung Transplant. 2014 Apr;33(4):359-65. doi: 10.1016/j.healun.2013.12.014. Epub 2013 Dec 27. — View Citation

Flint KM, Matlock DD, Lindenfeld J, Allen LA. Frailty and the selection of patients for destination therapy left ventricular assist device. Circ Heart Fail. 2012 Mar 1;5(2):286-93. doi: 10.1161/CIRCHEARTFAILURE.111.963215. Review. — View Citation

Molino-Lova R, Pasquini G, Vannetti F, Paperini A, Forconi T, Polcaro P, Zipoli R, Cecchi F, Macchi C. Effects of a structured physical activity intervention on measures of physical performance in frail elderly patients after cardiac rehabilitation: a pilot study with 1-year follow-up. Intern Emerg Med. 2013 Oct;8(7):581-9. doi: 10.1007/s11739-011-0654-z. Epub 2011 Jul 9. — View Citation

Singh M, Stewart R, White H. Importance of frailty in patients with cardiovascular disease. Eur Heart J. 2014 Jul;35(26):1726-31. doi: 10.1093/eurheartj/ehu197. Epub 2014 May 26. Review. — View Citation

Thalji NM, Suri RM, Greason KL, Schaff HV. Risk assessment methods for cardiac surgery and intervention. Nat Rev Cardiol. 2014 Dec;11(12):704-14. doi: 10.1038/nrcardio.2014.136. Epub 2014 Sep 23. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in frailty marker handgrip strength	Frailty is assessed by the strength of a participant's handgrip, measured using a commercial device.	Baseline, 6 weeks
Primary	Change in frailty marker gait speed	Frailty is assessed by the strength of a participant's gait speed, measured using a commercial device.	Baseline, 6 weeks
Secondary	Change in New York Heart Association (NYHA) classification	New York Heart Association (NYHA) Classification Scale Early-Stage Heart Failure; NYHA Class I No symptoms at any level of exertion and no limitation in ordinary physical activity.; NYHA Class II Mild symptoms and slight limitation during regular activity. Comfortable at rest.; Advanced-Stage Heart Failure; NYHA Class III Noticeable limitation due to symptoms, even during minimal activity. Comfortable only at rest.; NYHA Class IV Severe limitations. Experience symptoms even while at rest (sitting in a recliner or watching TV).	Baseline, 6 weeks
Secondary	Change in Minnesota Living with Heart Failure (MLHF) score	A participant's quality of life assessed by Minnesota Living with Heart Failure (MLHF) questionnaire score.	Baseline, 6 weeks
Secondary	Change in KCCQ score	A participant's quality of life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) questionnaire score.	Baseline, 6 weeks