Detroit, Michigan 48202

  • Acute Heart Failure

Purpose:

This is an observational study of the functional capacity of patients with Heart failure with Reduced Ejection Fraction (HFrEF) who are admitted to the hospital for routine medical treatment.


Study summary:

This observational study will evaluate the functional capacity (ability to walk and distance walked) of patients with Heart failure with Reduced Ejection Fraction (HFrEF) in approximately 50-70 patients who present with Acute Heart Failure to approximately 5-6 hospital sites in the USA. All enrolled patients will be evaluated for their baseline functional capacity. Patients will receive standard Acute Heart Failure therapy and will be serially assessed for change in their functional capacity.


Criteria:

Inclusion Criteria: - Have a left ventricular ejection fraction (LVEF) ≤40%, as assessed by any method, e.g., echocardiography, a multigated acquisition (MUGA) scan or magnetic resonance imaging (MRI); - Present with signs and symptoms considered to be primarily due to AHF and be admitted to the hospital for AHF; - Confirmation verbally that the patient was ambulatory, i.e., able to walk >30m, prior to developing symptoms of AHF leading to the current admission; - Be capable of understanding the nature of the trial; be willing and able to comply with the inpatient and outpatient study protocol requirements for the duration of the study; and be willing to participate, as documented by written informed consent. Exclusion Criteria: - Have a systolic blood pressure <90mmHg or >170mmHg at baseline; - Have an anticipated need for an invasive procedure within 3 days of study enrollment, e.g., due to hemodynamic or cardiac rhythm instability, or acute coronary syndrome, requiring procedures including, but not limited to, cardiac catheterization, placement of a defibrillator/pacemaker, or placement of a pulmonary artery catheter; - Have a primary HF etiology attributable to either restrictive/obstructive cardiomyopathy, idiopathic hypertrophic cardiomyopathy (as defined by any wall thickness > 1.8cm) that is obstructive, or uncorrected severe valvular disease (except mitral regurgitation); - Have any other comorbidities that limit ambulation more than the patient's heart failure, e.g., symptomatic peripheral arterial disease, COPD, arthritis or other condition, as confirmed verbally with the patient; - Have severe renal insufficiency (defined as a GFR <30mL/min/1.73m2 according to the MDRD equation); - Have an anticipated survival of less than 90 days, for any reason; - Have received an investigational agent (drug, device or biologic product) within 30 days (or, if longer, 5 half-lives for a drug or biologic agent) prior to study entry, or be planning to receive an investigational agent at any time throughout the full duration of the study until at least Study Day 35; - Have any other clinically significant laboratory abnormality, medical condition or social circumstance that, in the investigator's opinion, makes it inappropriate for the patient to participate in this clinical trial.


Study is Available At:


Original ID:

CXL-AHF-FC01


NCT ID:

NCT02350114


Secondary ID:

CV013-007


Study Acronym:


Brief Title:

An Observational Study of the Functional Capacity of Heart Failure


Official Title:

An Observational Study of the Functional Capacity of Heart Failure Patients With Reduced Ejection Fraction Admitted With Acute Heart Failure


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

85 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Bristol-Myers Squibb


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Intervention Model: Single Group Assignment, Maski


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

51


Enrollment Type:

Actual


Overall Contact Information

Official Name:ShiYin Foo, M.D., PhD.
Study Director
Cardioxyl Pharmaceiticals

Study Dates

Start Date:November 2014
Completion Date:July 2015
Completion Type:Actual
Primary Completion Date:May 2015
Primary Completion Type:Actual
Verification Date:June 2016
Last Changed Date:June 30, 2016
First Received Date:January 18, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Functional Capacity (The 6-minute walk test (6MWT))
Time Frame:Over up to 5 days of from time of hospitalization
Safety Issues:False
Description:The 6-minute walk test (6MWT) will be primary measure of functional capacity in these patients.
Outcome Type:Secondary Outcome
Measure:30-day readmission rates for heart failure
Time Frame:30 days following discharge from Hospital
Safety Issues:False
Description:Exploration of the the relationship between 30-day readmission rates for heart failure and functional capacity.

Study Interventions

Intervention Type:Procedure
Name:6 Minute Walk Test
Description:Evaluation of walking distance on standardized 6 minute walk test
Arm Name:Functional Capacity
Other Name:Walk Test

Study Arms

Study Arm Type:Experimental
Arm Name:Functional Capacity
Description:6 Minute Walk Test

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Bristol-Myers Squibb
Agency Class:Other
Agency Type:Collaborator
Agency Name:Colorado Prevention Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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