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

Dyspnea Clinical Trial

Official title:

Assessment of The Clinical Course of Dyspnea and Its Association With Respiratory Rate in Patients With Acute Heart Failure Syndromes

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01615926
• Other study ID #: MSSRP-IC2012
• Status: Terminated
• Phase: N/A
• First received: June 7, 2012
• Last updated: April 30, 2013
• Start date: June 2012
• Est. completion date: August 2012

Study information

• Verified date: April 2013
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Heart Failure
• Dyspnea
• Heart Failure

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the association between respiratory rate and self-reported dyspnea in AHF patients.		24 hours	No