Assessment of The Clinical Course of Dyspnea in Acute Heart Failure Patients

NCT ID: NCT01615926

Last Updated: 2013-05-01

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 16 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2012-08-31

Brief Summary

Acute heart failure (AHF) is defined as a gradual or rapid change in heart failure (HF) signs and symptoms, such as shortness of breath (also called dyspnea or breathlessness), leg swelling, fatigue, breathlessness with exertion, trouble sleeping flat at night, and weight gain resulting in a need for urgent therapy. AHF results in over 1 million hospitalizations every year, resulting in an enormous public health burden. Approximately 1/3rd of patients will either be re-hospitalized or die within three months, and the resultant financial costs are large. As such, improving outcomes for AHF patients is critically important. Shortness of breath is the most common reason why patients with AHF present to the ER. As such, understanding how severe this symptom is, how much it improves with current treatments is very important to both patients and physicians. The purpose of this study is to determine the degree to which your shortness of breath improves during the first few days of hospitalization and its association with how fast you are breathing.

Conditions

Acute Heart Failure; Dyspnea

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Male or female ≥ 18 years of age
• AHFS is the primary working diagnosis for ER management and treatment with planned admission
• Have received IV diuretic therapy
• Enrolled within 3 hours of initial diuretic dose

Exclusion Criteria

• BNP level is ≤ 300 pg/mL (may be initially enrolled and then will be excluded for second assessment)
• Transplant recipients of any kind
• Fever > 101.5
• Severe lung disease (required home O2 or daily oral steroids)
• Any ACS event within last 30 days
• Life expectancy less than 12 months for any reason
• Current treatment for any malignancy of any kind
• Cardiogenic shock and/or requiring IV inotropic therapy
• Pregnant or recently pregnant within last 90 days
• Inability to give appropriate written consent

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

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Peter Pang

Associate Professor of Emergency Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter S Pang, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern Memorial Hospital

Chicago, Illinois, United States

Countries

United States

Other Identifiers

MSSRP-IC2012

Identifier Type: -

Identifier Source: org_study_id