Recruiting

Observational Study

Sponsor:

Shape Medical Systems, Inc.

Code:

NCT01960218

Conditions

Acute Decompensated Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Acute Decompensated Heart Failure

Study ID

NCT01960218

Start date

Oct, 2013

Status verified date

Apr, 2014

Completion date

Jan, 2015

Anticipated

Primary completion date

Jul, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

acute decompensated heart failure

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.

Primary outcome measure

  • 1. To evaluate if exercise gas exchange tests can predict 30 day hospital readmission for heart failure. [ Time Frame: 30 days ± 3 days post discharge ]
  • 2. To evaluate which gas exchange patterns were most highly associated with 30 day risk of readmission for recurrent acute decompensated heart failure. [ Time Frame: 30 days ± 3 days post discharge ]
  • 3. To determine the incidence of Adverse Events (AE) and Serious Adverse Events (SAE). [ Time Frame: 30 days ± 3 days post discharge follow-up and through 180 days ± 15 days post discharge ]

Central Contacts and Locations

Locations

Veterans Affairs-Washington DC

Recruiting

Washington, District of Columbia, United States, 20422

Contacts

Jacqueline Gannuscio, DNP, ACNP

202-745-8000

Principal Investigator:

Jacqueline Gannuscio, DNP, ACNP

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Aaron Eisman

617-643-1697

Ashley Dress

617.643.1697

Principal Investigator:

Gregory Lewis, MD

Fairview Southdale

Recruiting

Edina, Minnesota, United States, 55435

Contacts

Jennifer Nelson, RN

612-625-9455

Principal Investigator:

Eric Ernst, MD

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Jennifer Nelson, RN

612-625-0455

Principal Investigator:

Peter Eckman, MD

Washington University of Medicine

Recruiting

St. Louis, Missouri, United States, 63110

Contacts

Jessica Biondo, RN

314-286-1767

Principal Investigator:

Gregory A Ewald, MD, FACC

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Ellen Slifcak, BA, RN

216-445-1776

Principal Investigator:

Nancy Albert, PhD., R.N.

More Information

Sponsor

Shape Medical Systems, Inc.

Last update posted

Apr 4, 2014

Last verified

Apr, 2014

Keywords

  • acute decompensated heart failure
  • gas exchange
  • cardiopulmonary
  • dyspnea
  • cardiopulmonary analyzer
  • heart disease
  • cardiovascular disease
  • cardiopulmonary exercise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Shape Medical Systems, Inc. on 2014-04-04.