Acute Decompensated Heart FailureNCT01960218
Gas Exchange for Predicting Hospital Heart Failure Readmissions
An observational study of Acute Decompensated Heart Failure, run by Shape Medical Systems, Inc. at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Decompensated Heart Failure
- How many people
- 120 participants
- Where
- 7 sitesUnited States
- Study dates
- Oct 2013to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be consecutively recruited from the population of subjects admitted to the hospital with acute decompensated heart failure.
Who may be able to join
- Subject is 18 Years and older
- Subject is hospitalized for acute decompensated heart failure (ADHF)
- Systolic OR
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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 locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Aaron Eisman, 617-643-1697
Ashley Dress, 617.643.1697
- Not yet recruiting
Christie Clinic
Champaign, Illinois, 61820
Diane Genthner, 217-337-2221
Abraham G Kocheril, MD
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Ellen Slifcak, BA, RN, 216-445-1776
Nancy Albert, PhD., R.N.
- Recruiting
Fairview Southdale
Edina, Minnesota, 55435
Jennifer Nelson, RN, 612-625-9455
Eric Ernst, MD
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Jennifer Nelson, RN, 612-625-0455
Peter Eckman, MD
- Recruiting
Washington University of Medicine
St Louis, Missouri, 63110
Jessica Biondo, RN, 314-286-1767
Gregory A Ewald, MD, FACC
- Recruiting
Veterans Affairs-Washington DC
Washington D.C., District of Columbia, 20422
Jacqueline Gannuscio, DNP, ACNP, 202-745-8000 ext. 7297
Jacqueline Gannuscio, DNP, ACNP
About this study
Official title: Gas Exchange for Predicting Hospital Heart Failure Readmissions Clinical Evaluation Study
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.
Read the 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.
- Conditions
- Acute Decompensated Heart Failure
- Keywords
- acute decompensated heart failure, gas exchange, cardiopulmonary, dyspnea, cardiopulmonary analyzer, heart disease, cardiovascular disease, cardiopulmonary exercise
- Medical subject headings
- Dyspnea, Heart Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. To evaluate if exercise gas exchange tests can predict 30 day hospital readmission for heart failure.
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.
Measured: 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.
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.
Measured: 30 days ± 3 days post discharge
3. To determine the incidence of Adverse Events (AE) and Serious Adverse Events (SAE).
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.
Measured: 30 days ± 3 days post discharge follow-up and through 180 days ± 15 days post discharge
Secondary outcomes (2)
1. To evaluate if exercise gas exchange tests can predict 180 day hospital readmission for heart failure.
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.
Measured: 180 days ± 15 days post discharge
2. To evaluate which gas exchange patterns were most highly associated with 180 day risk of readmission for recurrent acute decompensated heart failure.
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.
Measured: 180 days ± 15 days post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionJul 2014 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Decompensated Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shape Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Abraham G Kocheril, MD, Principal investigator, Christie Clinc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01960218
- Sponsor's protocol ID
- 0512
- Status last verified
- Apr 2014
- First submitted
- 4 Oct 2013
- Last updated
- 4 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Fang J, Mensah GA, Croft JB, Keenan NL. Heart failure-related hospitalization in the U.S., 1979 to 2004. J Am Coll Cardiol. 2008 Aug 5;52(6):428-34. doi: 10.1016/j.jacc.2008.03.061.
PubMed 18672162Pulignano G, Del Sindaco D, Tavazzi L, Lucci D, Gorini M, Leggio F, Porcu M, Scherillo M, Opasich C, Di Lenarda A, Senni M, Maggioni AP; IN-CHF Investigators. Clinical features and outcomes of elderly outpatients with heart failure followed up in hospital cardiology units: data from a large nationwide cardiology database (IN-CHF Registry). Am Heart J. 2002 Jan;143(1):45-55. doi: 10.1067/mhj.2002.119608.
PubMed 11773911Jacobs B. Reducing heart failure hospital readmissions from skilled nursing facilities. Prof Case Manag. 2011 Jan-Feb;16(1):18-24; quiz 25-6. doi: 10.1097/NCM.0b013e3181f3f684.
PubMed 21164330Yu CM, Wang L, Chau E, Chan RH, Kong SL, Tang MO, Christensen J, Stadler RW, Lau CP. Intrathoracic impedance monitoring in patients with heart failure: correlation with fluid status and feasibility of early warning preceding hospitalization. Circulation. 2005 Aug 9;112(6):841-8. doi: 10.1161/CIRCULATIONAHA.104.492207. Epub 2005 Aug 1.
PubMed 16061743
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gas Exchange for Predicting Hospital Heart Failure Readmissions Clinical Evaluation Study
- ClinicalTrials.gov ID
- NCT01960218
- Acronym / sponsor ID
- 0512
- Conditions
- Acute Decompensated Heart Failure
- Keywords
- acute decompensated heart failure, gas exchange, cardiopulmonary, dyspnea, cardiopulmonary analyzer, heart disease, cardiovascular disease, cardiopulmonary exercise
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shape Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 10 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be consecutively recruited from the population of subjects admitted to the hospital with acute decompensated heart failure.
Key inclusion criteria (8 listed)
- Subject is 18 Years and older
- Subject is hospitalized for acute decompensated heart failure (ADHF)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
Time frame: 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).
Time frame: 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.
2 secondary outcomes
1. To evaluate if exercise gas exchange tests can predict 180 day hospital readmission for heart failure.
Time frame: 180 days ± 15 days post discharge
2. To evaluate which gas exchange patterns were most highly associated with 180 day risk of readmission for recurrent acute decompensated heart failure.
Time frame: 180 days ± 15 days post discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2014.
- Background: PubMed 18672162Fang J, Mensah GA, Croft JB, Keenan NL. Heart failure-related hospitalization in the U.S., 1979 to 2004. J Am Coll Cardiol. 2008 Aug 5;52(6):428-34. doi: 10.1016/j.jacc.2008.03.061.
- Background: PubMed 11773911Pulignano G, Del Sindaco D, Tavazzi L, Lucci D, Gorini M, Leggio F, Porcu M, Scherillo M, Opasich C, Di Lenarda A, Senni M, Maggioni AP; IN-CHF Investigators. Clinical features and outcomes of elderly outpatients with heart failure followed up in hospital cardiology units: data from a large nationwide cardiology database (IN-CHF Registry). Am Heart J. 2002 Jan;143(1):45-55. doi: 10.1067/mhj.2002.119608.
- Background: PubMed 21164330Jacobs B. Reducing heart failure hospital readmissions from skilled nursing facilities. Prof Case Manag. 2011 Jan-Feb;16(1):18-24; quiz 25-6. doi: 10.1097/NCM.0b013e3181f3f684.
- Background: PubMed 16061743Yu CM, Wang L, Chau E, Chan RH, Kong SL, Tang MO, Christensen J, Stadler RW, Lau CP. Intrathoracic impedance monitoring in patients with heart failure: correlation with fluid status and feasibility of early warning preceding hospitalization. Circulation. 2005 Aug 9;112(6):841-8. doi: 10.1161/CIRCULATIONAHA.104.492207. Epub 2005 Aug 1.
Related trials for Acute Decompensated Heart Failure
Not yet recruitingPhase 3
Early Discharge With Subcutaneous Furosemide Versus Standard Care in Acute Heart Failure
Heart Failure, Acute Decompensated Heart Failure
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 3
Effects of Continued Administration of Empagliflozin in Patients With Heart Failure on Active SGLT2 Inhibitor Treatment Admitted for Acute Decompensated Heart Failure
Acute Decompensated Heart Failure (ADHF)
Recruiting
Low Level Tragus Stimulation in Acute Decompensated Heart Failure
Acute Decompensated Heart Failure
Recruiting
Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II) (IDE-G210258)
Acute Decompensated Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abraham G Kocheril, MD principal investigator
Christie Clinc
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Decompensated Heart Failure, run by Shape Medical Systems, Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01960218, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2014.