Cardiac Output in Heart Failure Patients With Mechanical Pumps

NCT05195931 | Terminated DMC

• 1 other identifier: 20-2143
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be looking at how cardiovascular hemodynamics, including cardiac output and flow through a left ventricular assist device (LVADs), change in response to alterations in preload, afterload, and contractility, and also during exercise, in humans with heart failure who are supported by LVADs.

Conditions

Heart Failure, Systolic; Mechanical Circulatory Support; Cardiovascular Hemodynamics

Outcome Measures

Primary Outcomes (1)

• cardiac output

  cardiac output from Swan-Ganz catheter

  5 minutes

Secondary Outcomes (5)

• mean arterial pressure

  5 minutes

• LVAD flow

  5 minutes

• right atrial pressure

  5 minutes

• mean pulmonary arterial pressure

  5 minutes

• pulmonary capillary wedge pressure

  5 minutes

Study Arms (2)

Preload and Afterload

10 participants with heart failure who are supported by LVADs will undergo hemodynamic monitoring and observation while undergoing changes in preload (head-up tilt and saline infusion), and afterload (nitroprusside and phenylephrine infusion).

Diagnostic Test: preload challenge; Diagnostic Test: afterload challenge

Contractility

10 participants with heart failure who are supported by LVADs will undergo hemodynamic monitoring and observation while undergoing changes in contractility with adjustments in heart rate (by adjusting pacemaker), dobutamine infusion, and during exercise.

Diagnostic Test: contractility assessment

Interventions

preload challenge DIAGNOSTIC_TEST

reduction in preload by head-up tilt and increase in preload with saline infusion

Preload and Afterload

afterload challenge DIAGNOSTIC_TEST

reduction in afterload with nitroprusside and increase in afterload with phenylephrine

Preload and Afterload

contractility assessment DIAGNOSTIC_TEST

heart rate changes will be made by increasing heart rate with external pacemaker/defibrillator. Contractility will be adjusted by dobutamine infusion. Patients will exercise at a constant pump speed and also with pump speed increases.

Contractility

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced heart failure who are supported by an LVAD

You may qualify if:

• Adults age 18 years of age or greater;
• Clinically stable, ambulatory outpatients with HVAD who are fully recovered from surgical implantation.

You may not qualify if:

• Confirmed or suspected device malfunction (e.g. pump thrombus, LVAD-related infection);
• Clinical instability, defined as hypotension (mean arterial pressure \< 60mmHg and symptomatic, as measured in the advanced heart failure LVAD clinic), or hypertension (mean arterial pressure \> 90mmHg); patients with refractory heart failure symptoms with New York Heart Association functional classification IIIB or IV symptoms;
• any chronic illness which would render the patient unable to complete the protocol as described, including but not limited to: moderate-severe osteoarthritis, severe pulmonary disease requiring supplemental oxygen, uncontrolled hypertension, a high baseline HVAD pump speed above 2860RPM (exercise protocol requires increasing pump speed by up to 240 RPM);
• chronic kidney disease with a glomerular filtration rate \< 30ml/min/1.73m2;
• absence of a pacemaker-defibrillator (necessary for pacing assessment as described below);
• individuals with clinical evidence of right ventricular (RV) dysfunction/failure, defined as moderate-severe hypervolemia on physical examination with elevated jugular venous pressure greater than 10cmH20, imaging evidence of severe RV dysfunction by imaging assessment or tricuspid annular plane systolic excursion \< 17mmHg, or use of outpatient inotropes for known history of RV dysfunction.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Snschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Heart Failure, Systolic

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases

Study Design

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

Study Record Dates

• First Submitted: June 18, 2021
• First Posted: January 19, 2022
• Study Start: June 8, 2021
• Primary Completion: August 25, 2022
• Study Completion: August 25, 2022
• Last Updated: May 19, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)