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

Heart Failure,Congestive Clinical Trial

— IRONMAN  

Official title:

Effective Mechanical Circulatory Support on Exercise Capacity in Heart Failure

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03078972
• Other study ID #: 16-1635
• Status: Active, not recruiting
• Start date: April 7, 2017
• Est. completion date: June 30, 2023

Study information

• Verified date: May 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure,Congestive

Locations

Country	Name	City	State
United States	University of Colorado Snschutz Medical Campus	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Changes in the hemodynamic response.	This outcome will evaluate any difference in the hemodynamic response (heart rate and blood pressure) to handgrip and PECA before and after CF-LVAD	4 weeks prior to implantation and 6 months post implantation.
Secondary	VO2 relationship and ventilatory threshold (1)	Cardiac output (Qc): VO2 relationship and ventilatory threshold before and after CF-LVAD insertion.	4 weeks prior to implantation and 6 months post implantation.
Secondary	VO2 relationship and ventilatory threshold (2).	Determinants of Qc after CF-LVAD insertion (ie, contribution from device v. contribution from left ventricle).	4 weeks prior to implantation and 6 months post implantation.
Secondary	VO2 relationship and ventilatory threshold (3).	Qc, VO2, ventilatory threshold and exercise capacity at increased pump speed.	4 weeks prior to implantation and 6 months post implantation.
Secondary	VO2 relationship and ventilatory threshold (4).	Bloodflow to the periphery, as measured by transcranial Doppler to assess brain bloodflow during exercise/activity.	4 weeks prior to implantation and 6 months post implantation.
Secondary	Oxygen uptake and utilization	Cerebral and musculoskeletal oxygen uptake by near-infrared spectroscopy	4 weeks prior to implantation and 6 months post implantation.