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

Heart Diseases Clinical Trial

— ROBIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03232736
• Other study ID #: 17-1042
• Status: Completed
• Start date: October 1, 2017
• Est. completion date: January 30, 2020

Study information

• Verified date: November 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 30, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Heart Diseases
• Left Ventricular Dysfunction
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Vo2	peak Vo2 measured by indirect calorimetry during cardiopulmonary exercise testing	20 minutes
Primary	Cardiac Output	cardiac output measured during invasive cardiopulmonary exercise testing.	20 minutes
Secondary	Blood Pressure	mean arterial pressure during exercise	20 minutes
Secondary	Respiratory Exchange Ratio	Respiratory exchange ratio derived from indirect calorimetry	20 minutes
Secondary	Minute Ventilation	Minute ventilation during cardiopulmonary exercise testing	20 minutes
Secondary	Tau	unit of measure of diastolic function during exercise	20 minutes
Secondary	Stroke Work	stroke work during exercise	20 minutes
Secondary	EES/EA	ventricular arterial coupling during exercise	20 minutes