Clinical trial NCT03232736: InterventiOn of Biventricular Pacemaker Function on ventrIcular Function Among Patients With LVAD's
Official title: Randomized interventiOn of Biventricular Pacemaker Function on ventrIcular Function Among Patients With mechaNical Circulatory Support Devices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Diseases
Left Ventricular Dysfunction
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2017-07-28
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 15 patients with advanced HF who have already undergone CF-LVAD implantation.

10 healthy individuals will serve as a control group to define normal RV function during exercise.

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 "mechanical hearts"). Second, the investigators are interested in understanding how different pacemaker settings influence function of the heart at rest and activity.

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 rest and with exercise during invasive cardiopulmonary exercise testing on upright cycle ergometry.

Eligibility criteria: 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:

1. Have already received CF-LVADs and are clinically stable,
2. Ambulatory outpatients and are fully recovered (at least 3 months) from LVAD implantation;

Exclusion criteria:

1. Individuals with clinical right ventricular (RV) failure under resting conditions, defined as moderate-severely reduced RV systolic function on echocardiography, or
2. Clinical evidence of RV failure (elevated jugular venous pressures, 3 or 4+ \[significant\] peripheral edema);
3. 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:

1. hypertension,
2. diabetes,
3. peripheral vascular disease,
4. arrhythmias,

f. are not taking any cardiac-related medications (e.g. antihypertensive medications).

Exclusion criteria:

1. Individuals requiring systemic anticoagulation with vitamin-K antagonists or new/direct oral anticoagulants ("NOAC"/"DOAC");
2. Disorders that adversely influence exercise ability (e.g. arthritis, peripheral vascular disease).

Primary outcomes:
measure: Peak Vo2
timeFrame: 20 minutes
measure: Cardiac Output
timeFrame: 20 minutes
Secondary outcomes:
measure: Blood Pressure
timeFrame: 20 minutes
measure: Respiratory Exchange Ratio
timeFrame: 20 minutes
measure: Minute Ventilation
timeFrame: 20 minutes
measure: Tau
timeFrame: 20 minutes
measure: Stroke Work
timeFrame: 20 minutes
measure: EES/EA
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: William Cornwell, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cornwell WK, Tran T, Cerbin L, Coe G, Muralidhar A, Hunter K, Altman N, Ambardekar AV, Tompkins C, Zipse M, Schulte M, O'Gean K, Ostertag M, Hoffman J, Pal JD, Lawley JS, Levine BD, Wolfel E, Kohrt WM, Buttrick P. New insights into resting and exertional right ventricular performance in the healthy heart through real-time pressure-volume analysis. J Physiol. 2020 Jul;598(13):2575-2587. doi: 10.1113/JP279759. Epub 2020 May 18.
citation: Tran T, Muralidhar A, Hunter K, Buchanan C, Coe G, Hieda M, Tompkins C, Zipse M, Spotts MJ, Laing SG, Fosmark K, Hoffman J, Ambardekar AV, Wolfel EE, Lawley J, Levine B, Kohrt WM, Pal J, Cornwell WK 3rd. Right ventricular function and cardiopulmonary performance among patients with heart failure supported by durable mechanical circulatory support devices. J Heart Lung Transplant. 2021 Feb;40(2):128-137. doi: 10.1016/j.healun.2020.11.009. Epub 2020 Nov 22.