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Trial record 2 of 146 for:    heart OR vascular OR aortic OR ventricular | Recruiting Studies | university of colorado

Effect of mechanIcal circulatoRy Support ON Exercise Capacity aMong pAtieNts With Heart Failure (IRONMAN)

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ClinicalTrials.gov Identifier: NCT03078972
Recruitment Status : Recruiting
First Posted : March 14, 2017
Last Update Posted : May 10, 2018
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
This study will evaluate how the cardiovascular system interacts with mechanical hearts to provide blood flow to the body during exercise. Two aims are proposed: 1) to determine the impact of a mechanical heart on exercise pressor reflexes in heart failure patients; and 2) to define the primary determinant(s) of exercise capacity in heart failure patients before and after device implantation.

Condition or disease
Heart Failure,Congestive

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effective Mechanical Circulatory Support on Exercise Capacity in Heart Failure
Actual Study Start Date : April 7, 2017
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Group/Cohort
Advanced Heart Failure
40 patients with advanced heart failure scheduled to undergo Left Ventricular Assist Device (LVAD) insertion will be recruited for testing. Test subjects will complete testing prior to, and following LVAD implantation.
Healthy controls
10 age-matched healthy individuals will be recruited to establish normal/reference values.
Mild Heart Failure
A second control group comprised of 10 age-matched individuals will be recruited to establish normal/reference values for individuals with mild, medically managed heart failure.



Primary Outcome Measures :
  1. Changes in the sympathetic neural response. [ Time Frame: 4 weeks prior to implantation and 6 months post implantation. ]
    The primary outcome will be the difference in the muscle sympathetic neural response (MSNA) to handgrip and post-exercise circulatory arrest (PECA) before and after Continuous-flow left ventricular assist device (CF-LVAD) insertion

  2. Change in VO2. [ Time Frame: 4 weeks prior to implantation and 6 months post implantation. ]
    The primary outcome will be the change in the VO2 (maximum rate of oxygen consumption) before and after CF-LVAD insertion.


Secondary Outcome Measures :
  1. Changes in the hemodynamic response. [ Time Frame: 4 weeks prior to implantation and 6 months post implantation. ]
    This outcome will evaluate any difference in the hemodynamic response (heart rate and blood pressure) to handgrip and PECA before and after CF-LVAD

  2. VO2 relationship and ventilatory threshold (1) [ Time Frame: 4 weeks prior to implantation and 6 months post implantation. ]
    Cardiac output (Qc): VO2 relationship and ventilatory threshold before and after CF-LVAD insertion.

  3. VO2 relationship and ventilatory threshold (2). [ Time Frame: 4 weeks prior to implantation and 6 months post implantation. ]
    Determinants of Qc after CF-LVAD insertion (ie, contribution from device v. contribution from left ventricle).

  4. VO2 relationship and ventilatory threshold (3). [ Time Frame: 4 weeks prior to implantation and 6 months post implantation. ]
    Qc, VO2, ventilatory threshold and exercise capacity at increased pump speed.

  5. VO2 relationship and ventilatory threshold (4). [ Time Frame: 4 weeks prior to implantation and 6 months post implantation. ]
    Bloodflow to the periphery, as measured by transcranial Doppler to assess brain bloodflow during exercise/activity.

  6. Oxygen uptake and utilization [ Time Frame: 4 weeks prior to implantation and 6 months post implantation. ]
    Cerebral and musculoskeletal oxygen uptake by near-infrared spectroscopy


Biospecimen Retention:   Samples Without DNA
Approximately 20cc of blood will be collected during testing.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

40 - HF patients with advanced heart failure who are scheduled to undergo LVAD insertion (Advanced Heart Failure)

10 - HF patients with mild heart failure who are not scheduled to undergo LVAD insertion, to serve as first control group (Mild Heart Failure)

10 - Age-matched healthy individuals, with no past medical history, to serve as a second control group (Healthy Controls)

Criteria

Advanced Heart Failure-

Inclusion Criteria:

  • Individuals with severely reduced left ventricular systolic function that are scheduled to undergo LVAD insertion

Exclusion Criteria:

  • uncontrolled diabetes with peripheral neuropathy (interferes with acquisition of MSNA signal)
  • Individuals with clinical right ventricular failure, defined as moderate-severely reduced RV systolic function on echocardiography, or clinical evidence of RV failure (elevated jugular venous pressures, significant peripheral edema)
  • Individuals with moderate-severe preexisting aortic insufficiency, as these patients will typically undergo a Park stitch at time of CF-LVAD insertion to permanently close the aortic valve and prevent worsening aortic insufficiency; and
  • Disorders that adversely influence exercise ability (e.g. arthritis, peripheral vascular disease, pulmonary disease)

Mild Heart Failure -

Inclusion Criteria:

  • Individuals with medically managed left ventricular systolic function that are NOT scheduled to undergo LVAD insertion
  • HF patients with ejection fraction <35-40%

Exclusion Criteria:

  • Individuals requiring systemic anticoagulation with vitamin-K antagonists or new/direct oral anticoagulants ("NOAC"/"DOAC")
  • Disorders that adversely influence exercise ability (e.g. arthritis, peripheral vascular disease, pulmonary disease)
  • History of uncontrolled arrhythmias (e.g. ventricular tachycardia or nonsustained ventricular tachycardia).

Healthy Controls -

Inclusion Criteria:

- Persons without a past medical history of cardiovascular disease or related disease (e.g. hypertension, diabetes, peripheral vascular disease, arrhythmias, stroke/transient ischemic attack) and are not taking any cardiac-related medications (e.g. antihypertensive medications)

Exclusion Criteria:

  • Individuals requiring systemic anticoagulation with vitamin-K antagonists or new/direct oral anticoagulants ("NOAC"/"DOAC")
  • Disorders that adversely influence exercise ability (e.g. arthritis, peripheral ascular disease).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03078972


Contacts
Contact: William K Cornwell, MD 303-724-2085 william.cornwell@ucdenver.edu

Locations
United States, Colorado
University of Colorado Snschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: William K Cornwell III, MD         
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: William K Cornwell, MD University of Colorado, Denver

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03078972     History of Changes
Other Study ID Numbers: 16-1635
First Posted: March 14, 2017    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases