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

NCT03232736 | Completed Results DMC

• 1 other identifier: 17-1042
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Diseases; Left Ventricular Dysfunction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Blood Pressure

  20 minutes

• Respiratory Exchange Ratio

  20 minutes

• Minute Ventilation

  20 minutes

• Tau

  20 minutes

• Stroke Work

  20 minutes

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Related 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.

  PMID: 32347547 BACKGROUND

• 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.

  PMID: 33281029 BACKGROUND

MeSH Terms

Conditions

Heart Diseases; Ventricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Ventricular Dysfunction

Results Point of Contact

• Title: William Cornwell
• Organization: University of Colorado Anschutz Medical Campus

william.cornwell@ucdenver.edu

16142961686

Study Officials

• William Cornwell, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: July 28, 2017
• Study Start: October 1, 2017
• Primary Completion: January 30, 2020
• Study Completion: January 30, 2020
• Last Updated: November 14, 2023
• Results First Posted: August 27, 2021

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)