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OpenTrials
Completed

NCT Number: NCT03232736

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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).

Treatment and study plan

Primary outcomes

  1. Peak Vo2

    Time frame: 20 minutes

    peak Vo2 measured by indirect calorimetry during cardiopulmonary exercise testing

  2. Cardiac Output

    Time frame: 20 minutes

    cardiac output measured during invasive cardiopulmonary exercise testing.

Secondary outcomes

  1. Blood Pressure

    Time frame: 20 minutes

    mean arterial pressure during exercise

  2. Respiratory Exchange Ratio

    Time frame: 20 minutes

    Respiratory exchange ratio derived from indirect calorimetry

  3. Minute Ventilation

    Time frame: 20 minutes

    Minute ventilation during cardiopulmonary exercise testing

  4. Tau

    Time frame: 20 minutes

    unit of measure of diastolic function during exercise

  5. Stroke Work

    Time frame: 20 minutes

    stroke work during exercise

  6. EES/EA

    Time frame: 20 minutes

    ventricular arterial coupling during exercise

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

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

Acronym: ROBIN

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jul 28, 2017
Registry last updated
Nov 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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