Cardiac Rehab for Advanced Heart Failure-LVAD Candidates

NCT ID: NCT03132441

Last Updated: 2018-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-30

Study Completion Date

2018-02-28

Brief Summary

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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

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single arm pilot study
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Cardiac Rehabilitation

Strength Training for Frailty:

All patients enrolled will be enrolled in 6 weeks of cardiac rehabilitation for the pilot study.

Group Type EXPERIMENTAL

Strength Training for Frailty

Intervention Type OTHER

Cardiac Rehabilitation, abbreviated course

Interventions

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Strength Training for Frailty

Cardiac Rehabilitation, abbreviated course

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Sudhir Kushwaha

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sudhir S Kushwaha, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic-Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 24864078 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24486165 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25245832 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22438521 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24569037 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21744061 (View on PubMed)

Other Identifiers

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17-000210

Identifier Type: -

Identifier Source: org_study_id

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