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

NCT03078972 | Unknown DMC

• 1 other identifier: 16-1635
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure，Congestive

Outcome Measures

Primary Outcomes (2)

• Changes in the sympathetic neural response.

  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

  4 weeks prior to implantation and 6 months post implantation.

• Change in VO2.

  The primary outcome will be the change in the VO2 (maximum rate of oxygen consumption) before and after CF-LVAD insertion.

  4 weeks prior to implantation and 6 months post implantation.

Secondary Outcomes (6)

• Changes in the hemodynamic response.

  4 weeks prior to implantation and 6 months post implantation.

• VO2 relationship and ventilatory threshold (1)

  4 weeks prior to implantation and 6 months post implantation.

• VO2 relationship and ventilatory threshold (2).

  4 weeks prior to implantation and 6 months post implantation.

• VO2 relationship and ventilatory threshold (3).

  4 weeks prior to implantation and 6 months post implantation.

• VO2 relationship and ventilatory threshold (4).

  4 weeks prior to implantation and 6 months post implantation.

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Snschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Related Publications (3)

• Buchanan C, Buchanan C, Riordan M, Byrd J, Schulte M, Kohrt WM, Ambardekar AV, Allen LA, Wolfel G, Lawley J, Levine BD, Cornwell WK 3rd. Cardiopulmonary Performance Among Heart Failure Patients Before and After Left Ventricular Assist Device Implantation. JACC Heart Fail. 2024 Jan;12(1):117-129. doi: 10.1016/j.jchf.2023.06.017. Epub 2023 Aug 23.

  PMID: 37632493 DERIVED

• Edward JA, Parker H, Stohr EJ, McDonnell BJ, O'Gean K, Schulte M, Lawley JS, Cornwell WK 3rd. Exertional Cardiac and Pulmonary Vascular Hemodynamics in Patients With Heart Failure With Reduced Ejection Fraction. J Card Fail. 2023 Sep;29(9):1276-1284. doi: 10.1016/j.cardfail.2023.01.010. Epub 2023 Mar 5.

  PMID: 36871613 DERIVED

• Sailer C, Edelmann H, Buchanan C, Giro P, Babcock M, Swanson C, Spotts M, Schulte M, Pratt-Cordova A, Coe G, Beindorff M, Page RL 2nd, Ambardekar AV, Pal JD, Kohrt W, Wolfel E, Lawley JS, Tarumi T, Cornwell WK 3rd. Impairments in Blood Pressure Regulation and Cardiac Baroreceptor Sensitivity Among Patients With Heart Failure Supported With Continuous-Flow Left Ventricular Assist Devices. Circ Heart Fail. 2021 Jan;14(1):e007448. doi: 10.1161/CIRCHEARTFAILURE.120.007448. Epub 2021 Jan 19.

  PMID: 33464953 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Approximately 20cc of blood will be collected during testing.

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• William K Cornwell, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2017
• First Posted: March 14, 2017
• Study Start: April 7, 2017
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: May 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)