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Heart FailureNCT03132441

Cardiac Rehab for Advanced Heart Failure-LVAD Candidates

A study testing Strength Training for Frailty in people with Heart Failure, run by Mayo Clinic at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
Strength Training for Frailty
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Apr 2017to Feb 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Candidate for a Left Ventricular Assist Device (LVAD)
  • Advanced Heart Failure as determined by New York Heart Association classification III or IV

Who cannot join

  • Unable to perform physical activities required by protocol due to anatomic or musculoskeletal comorbidities
  • Physical activity is contraindicated

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic-Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Heart Failure
Being tested
Strength Training for Frailty
Keywords
advanced heart failure, NYHA Class III-IV, frailty, cardiac rehabilitation
Medical subject headings
Heart Failure, Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Strength Training for FrailtyOther

    Cardiac Rehabilitation, abbreviated course

Study groups in NCT03132441
Study groupRoleWhat they receive
Cardiac RehabilitationExperimentalStrength Training for Frailty: All patients enrolled will be enrolled in 6 weeks of cardiac rehabilitation for the pilot study.
Receives: Other: Strength Training for Frailty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in frailty marker handgrip strength

    Frailty is assessed by the strength of a participant's handgrip, measured using a commercial device.

    Measured: Baseline, 6 weeks

  2. Change in frailty marker gait speed

    Frailty is assessed by the strength of a participant's gait speed, measured using a commercial device.

    Measured: Baseline, 6 weeks

Secondary outcomes (3)

  1. 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).

    Measured: Baseline, 6 weeks

  2. 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.

    Measured: Baseline, 6 weeks

  3. Change in KCCQ score

    A participant's quality of life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) questionnaire score.

    Measured: Baseline, 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2017
  2. Study startApr 2017 (estimated)
  3. Primary completionFeb 2018 (estimated)
  4. Study completionFeb 2018 (estimated)

Why it stopped: Major changes to study that were better suited to creating a whole new study

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
Single arm pilot study
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03132441
Sponsor's protocol ID
17-000210
Status last verified
Jun 2018
First submitted
25 Apr 2017
Last updated
26 Jun 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24864078

  • 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.

    PubMed 24486165

  • 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.

    PubMed 25245832

  • 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.

    PubMed 22438521

  • 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.

    PubMed 24569037

  • 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.

    PubMed 21744061

Questions about this trial

What is this clinical trial studying?

A study testing Strength Training for Frailty in people with Heart Failure, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in frailty marker handgrip strength (time frame: Baseline, 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03132441, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2018.

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