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

NCT01615926 | Terminated

• 1 other identifier: MSSRP-IC2012
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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

Keywords

dyspnea; shortness of breath; respiratory rate; orthopnea

Outcome Measures

Primary Outcomes (1)

• To determine the association between respiratory rate and self-reported dyspnea in AHF patients.

  24 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients who present to the Emergency Department with Acute Heart Failure

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter S Pang, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Emergency Medicine

Study Record Dates

• First Submitted: June 7, 2012
• First Posted: June 11, 2012
• Study Start: June 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: May 1, 2013

Record last verified: 2013-04

Locations

US (1)