Gas Exchange for Predicting Hospital Heart Failure Readmissions

Shape Medical Systems

Status: Unknown

Conditions: Acute Decompensated Heart Failure

Study type: Observational

Funder types: Industry

Identifiers

NCT01960218

0512

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

120 participants in 1 patient group

acute decompensated heart failure

Description:

Adult subjects anticipating discharge from a hospitalization where the primary discharge diagnosis is acute decompensated heart failure and who are not excluded due to existing conditions.