Status:
TERMINATED
Cardiac Output in Heart Failure Patients With Mechanical Pumps
Lead Sponsor:
University of Colorado, Denver
Conditions:
Heart Failure, Systolic
Mechanical Circulatory Support
Eligibility:
All Genders
18-80 years
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, afterlo...
Detailed Description
Heart failure is a devastating disease, which affects approximately 6 million individuals in the USA alone. Five-year survival among all-comers with HFrEF is \~50%, and there are associated reductions...
Eligibility Criteria
Inclusion
- Adults age 18 years of age or greater;
- Clinically stable, ambulatory outpatients with HVAD who are fully recovered from surgical implantation.
Exclusion
- 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.
Key Trial Info
Start Date :
June 8 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 25 2022
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT05195931
Start Date
June 8 2021
End Date
August 25 2022
Last Update
May 19 2023
Active Locations (1)
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1
University of Colorado Snschutz Medical Campus
Aurora, Colorado, United States, 80045