Cardiac Rehab for Advanced Heart Failure-LVAD Candidates

June 21, 2018 updated by: Sudhir Kushwaha, Mayo Clinic

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic-Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cardiac Rehabilitation

Strength Training for Frailty:

All patients enrolled will be enrolled in 6 weeks of cardiac rehabilitation for the pilot study.
Other: Strength Training for Frailty
Cardiac Rehabilitation, abbreviated course

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in frailty marker handgrip strength
Time Frame: Baseline, 6 weeks
Frailty is assessed by the strength of a participant's handgrip, measured using a commercial device.
Baseline, 6 weeks
Change in frailty marker gait speed
Time Frame: Baseline, 6 weeks
Frailty is assessed by the strength of a participant's gait speed, measured using a commercial device.
Baseline, 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in New York Heart Association (NYHA) classification
Time Frame: Baseline, 6 weeks

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
Change in Minnesota Living with Heart Failure (MLHF) score
Time Frame: Baseline, 6 weeks
A participant's quality of life assessed by Minnesota Living with Heart Failure (MLHF) questionnaire score.
Baseline, 6 weeks
Change in KCCQ score
Time Frame: Baseline, 6 weeks
A participant's quality of life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) questionnaire score.
Baseline, 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Sudhir S Kushwaha, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2017

Primary Completion (Anticipated)

February 1, 2018

Study Completion (Anticipated)

February 1, 2018

Study Registration Dates

First Submitted

April 25, 2017

First Submitted That Met QC Criteria

April 25, 2017

First Posted (Actual)

April 27, 2017

Study Record Updates

Last Update Posted (Actual)

June 26, 2018

Last Update Submitted That Met QC Criteria

June 21, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-000210

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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