Acute Decompensated Heart Failure
Conditions
Keywords
acute decompensated heart failure, gas exchange, cardiopulmonary, dyspnea, cardiopulmonary analyzer, heart disease, cardiovascular disease, cardiopulmonary exercise
Brief summary
To determine whether, and if so, which gas exchange parameters measured on the Shape-HF Cardiopulmonary Exercise Testing System predict 30 and 180 day re-hospitalization in subjects discharged from hospitalization for an episode of acute decompensated heart failure.
Detailed description
This is a prospective, single-specialty clinical study. This study is intended to evaluate the select gas exchange parameters during a short, sub-max bout of exercise using a simple stationary step on day of discharge to predict the subjects' readmission for acute decompensated heart failure.
Interventions
None listed
Sponsors
Shape Medical Systems, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is 18 Years and older * Subject is hospitalized for acute decompensated heart failure (ADHF) 1. Systolic OR 2. Diastolic * Subject is Stage C:Class II/III/IV heart failure * Subject is willing and to provide appropriate informed consent * Subject is willing and able to comply with the requirements of the protocol, including follow-up evaluations and schedule * Subject is willing to use the Shape-HF Cardiopulmonary Exercise Testing System
Exclusion criteria
* The subject is pregnant (verified in a manner consistent with institution's standard of care) * Subject is currently participating in another investigational device or drug trial * Subject is a prisoner, a minor or unable to adequately give informed consent due to mental or physical condition * Subject is unwilling or unable to return for the required follow-up after test * Subject has Left Ventricular Assist Device (LVAD) * Subject is listed for transplant * Subject has a clinical diagnosis of acute myocardial infarction (AMI) on admission (Note: If troponin measurements have been collected and are elevated but not due to an MI subject is still eligible for study) * Subject has a pulmonary embolism (PE) on admission * Subject is dialysis dependent * Subject has a cardiac resynchronization device (CRT) which has been re-programmed at any time during the study * Subject has Chronic Obstructive Pulmonary Disease (COPD) who is oxygen or steroid dependent * Subject has severe hypertension \> 180 millimeter of mercury (mmHg) resting systolic at time of test * Subject has severe heart failure with renal insufficiency (with Creatinine clearance rate (CrCL) of 30 or less) and/or on IV Inotropic therapy and/or enrolling in hospice
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1. To evaluate if exercise gas exchange tests can predict 30 day hospital readmission for heart failure. | 30 days ± 3 days post discharge | The analysis of exercise gas exchange (using the Shape-HF Cardiopulmonary Exercise Testing System) of the incidence of hospital readmission through 30 days ± 3 days post discharge follow-up. |
| 2. To evaluate which gas exchange patterns were most highly associated with 30 day risk of readmission for recurrent acute decompensated heart failure. | 30 days ± 3 days post discharge | The analysis of exercise gas exchange (using the Shape-HF Cardiopulmonary Exercise Testing System) of the incidence of hospital readmission through 30 days ± 3 days post discharge follow-up. |
| 3. To determine the incidence of Adverse Events (AE) and Serious Adverse Events (SAE). | 30 days ± 3 days post discharge follow-up and through 180 days ± 15 days post discharge | The analysis of the incidence of AEs and SAEs on the day of discharge post Shape-HF Cardiopulmonary Exercise Testing System through 30 days ± 3 days post discharge follow-up and through 180 days ± 15 days post discharge follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1. To evaluate if exercise gas exchange tests can predict 180 day hospital readmission for heart failure. | 180 days ± 15 days post discharge | The analysis of exercise gas exchange (using the Shape-HF Cardiopulmonary Exercise Testing System) of the incidence of hospital readmission through 180 days ± 15 days post discharge follow-up. |
| 2. To evaluate which gas exchange patterns were most highly associated with 180 day risk of readmission for recurrent acute decompensated heart failure. | 180 days ± 15 days post discharge | The analysis of exercise gas exchange (using the Shape-HF Cardiopulmonary Exercise Testing System) of the incidence of hospital readmission through 180 days ± 15 days post discharge follow-up. |
Countries
United States
Outcome results
None listed