N/A
N=22
InterventiOn of Biventricular Pacemaker Function on ventrIcular Function Among Patients With LVAD's
Heart Diseases · Left Ventricular Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT03232736 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Peak Vo2 — 33; 12.5 ml/kg/min
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Vo2 |
33; 12.5 | — |
| PRIMARY Cardiac Output |
18.4; 9.1 | — |
| SECONDARY Blood Pressure |
119; 91 | — |
| SECONDARY Respiratory Exchange Ratio |
1.08; 0.03 | — |
| SECONDARY Minute Ventilation |
102; 56 | — |
| SECONDARY Tau |
25; 54 | — |
| SECONDARY Stroke Work |
4999; 2455 | — |
| SECONDARY EES/EA |
1.6; 1.40 | — |
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.
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
- 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).
Data sourced from ClinicalTrials.gov (NCT03232736). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.