Clinical trial NCT03132441: Cardiac Rehab for Advanced Heart Failure-LVAD Candidates
Official title: A Prospective Trial to Evaluate the Utility of Focused Frailty Interventions on Patients Undergoing Evaluation for Left Ventricular Assist Device (LVAD) Placement
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Heart Failure
Keywords: advanced heart failure
NYHA Class III-IV
frailty
cardiac rehabilitation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-04-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm pilot study
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in frailty marker handgrip strength
timeFrame: Baseline, 6 weeks
measure: Change in frailty marker gait speed
timeFrame: Baseline, 6 weeks
Secondary outcomes:
measure: Change in New York Heart Association (NYHA) classification
timeFrame: Baseline, 6 weeks
measure: Change in Minnesota Living with Heart Failure (MLHF) score
timeFrame: Baseline, 6 weeks
measure: Change in KCCQ score
timeFrame: Baseline, 6 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic-Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Sudhir S Kushwaha, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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. No abstract available.
citation: 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.
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.