InterventiOn of Biventricular Pacemaker Function on ventrIcular Function Among Patients With LVAD's (ROBIN)

Randomized interventiOn of Biventricular Pacemaker Function on ventrIcular Function Among Patients With mechaNical Circulatory Support Devices

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.

Study Overview

• Status: Completed
• Conditions: Heart Diseases; Left Ventricular Dysfunction

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.

• Study Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Healthy Control; Individuals free of cardiovascular disease and not on any medications to treat a cardiovascular-related condition
LVAD Group; Individuals with history of advanced heart failure who are supported by left ventricular assist devices

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Vo2	peak Vo2 measured by indirect calorimetry during cardiopulmonary exercise testing	20 minutes
Cardiac Output	cardiac output measured during invasive cardiopulmonary exercise testing.	20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure	mean arterial pressure during exercise	20 minutes
Respiratory Exchange Ratio	Respiratory exchange ratio derived from indirect calorimetry	20 minutes
Minute Ventilation	Minute ventilation during cardiopulmonary exercise testing	20 minutes
Tau	unit of measure of diastolic function during exercise	20 minutes
Stroke Work	stroke work during exercise	20 minutes
EES/EA	ventricular arterial coupling during exercise	20 minutes

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: William Cornwell, MD, University of Colorado, Denver

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): January 30, 2020
• Study Completion (Actual): January 30, 2020

Study Registration Dates

• First Submitted: July 20, 2017
• First Submitted That Met QC Criteria: July 27, 2017
• First Posted (Actual): July 28, 2017

Study Record Updates

• Last Update Posted (Actual): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 9, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Ventricular Dysfunction; Ventricular Dysfunction, Left
• Other Study ID Numbers: 17-1042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No