Status:
COMPLETED
InterventiOn of Biventricular Pacemaker Function on ventrIcular Function Among Patients With LVAD's
Lead Sponsor:
University of Colorado, Denver
Conditions:
Heart Diseases
Left Ventricular Dysfunction
Eligibility:
All Genders
18-80 years
Brief Summary
The primary reason the investigators are doing this study are to understand how the right side of the heart functions in heart failure patients with left ventricular assist devices (LVADs, or "mechani...
Detailed Description
Healthy individuals, as well as patients with advanced heart failure supported by LVADs, completed invasive hemodynamic analysis at rest and with exercise to characterize right-sided heart function at...
Eligibility Criteria
Inclusion
- 15 patients with advanced heart failure (HF) who have already undergone implantation of a continuous-flow left ventricular assist device (CF-LVAD) implantation.
- Inclusion criteria:
- Have already received CF-LVADs and are clinically stable,
- Ambulatory outpatients and are fully recovered (at least 3 months) from LVAD implantation;
- Exclusion criteria:
- Individuals with clinical right ventricular (RV) failure under resting conditions, defined as moderate-severely reduced RV systolic function on echocardiography, or
- Clinical evidence of RV failure (elevated jugular venous pressures, 3 or 4+ \[significant\] peripheral edema);
- Disorders that adversely influence exercise ability (e.g. arthritis, peripheral vascular disease, pulmonary disease); and
- 10 healthy individuals will serve as a control group to define normal RV function during exercise.
- Inclusion criteria:
- 1\) Persons without a past medical history of cardiovascular disease or related disease such as:
- hypertension,
- diabetes,
- peripheral vascular disease,
- arrhythmias,
- f. 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 vascular disease).
Exclusion
Key Trial Info
Start Date :
October 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 30 2020
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03232736
Start Date
October 1 2017
End Date
January 30 2020
Last Update
November 14 2023
Active Locations (1)
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1
University of Colorado Hospital
Aurora, Colorado, United States, 80045