An Observational Study of the Functional Capacity of Heart Failure

NCT ID: NCT02350114

Last Updated: 2016-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2015-07-31

Brief 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.

Detailed 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.

Conditions

Acute Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Functional Capacity

6 Minute Walk Test

Group Type: EXPERIMENTAL

6 Minute Walk Test

Intervention Type: PROCEDURE

Evaluation of walking distance on standardized 6 minute walk test

Interventions

6 Minute Walk Test

Evaluation of walking distance on standardized 6 minute walk test

Intervention Type: PROCEDURE

Other Intervention Names

Walk Test

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Colorado Prevention Center

OTHER

Sponsor Role: collaborator

Cardioxyl Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ShiYin Foo, M.D., PhD.

Role: STUDY_DIRECTOR

Cardioxyl Pharmaceiticals

Locations

Cardioxyl Study Site

Indianapolis, Indiana, United States

Cardioxyl Study Site

Detroit, Michigan, United States

Cardioxyl Study Site

Detroit, Michigan, United States

Cardioxyl Study Site

Winston-Salem, North Carolina, United States

Cardioxyl Study Site

Cincinnati, Ohio, United States

Cardioxyl Study Site

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

CV013-007

Identifier Type: OTHER

Identifier Source: secondary_id

CXL-AHF-FC01

Identifier Type: -

Identifier Source: org_study_id