An Observational Study of the Functional Capacity of Heart Failure

Acute Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02350114
• Other study ID #: CXL-AHF-FC01
• Secondary ID: CV013-007
• Status: Completed
• Phase: N/A
• First received: January 18, 2015
• Last updated: June 30, 2016
• Start date: November 2014
• Est. completion date: July 2015

Study information

• Verified date: June 2016
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: July 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Acute Heart Failure
• Heart Failure

Intervention

Procedure:
• 6 Minute Walk Test
Evaluation of walking distance on standardized 6 minute walk test

Locations

Country	Name	City	State
United States	Cardioxyl Study Site	Cincinnati	Ohio
United States	Cardioxyl Study Site	Detroit	Michigan
United States	Cardioxyl Study Site	Detroit	Michigan
United States	Cardioxyl Study Site	Indianapolis	Indiana
United States	Cardioxyl Study Site	Nashville	Tennessee
United States	Cardioxyl Study Site	Winston Salem	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Colorado Prevention Center, This trial was conducted by the previous sponsor, Cardioxyl Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Capacity (The 6-minute walk test (6MWT))	The 6-minute walk test (6MWT) will be primary measure of functional capacity in these patients.	Over up to 5 days of from time of hospitalization	No
Secondary	30-day readmission rates for heart failure	Exploration of the the relationship between 30-day readmission rates for heart failure and functional capacity.	30 days following discharge from Hospital	No

External Links

•   FDA Safety Alerts and Recalls