Assessment of The Clinical Course of Dyspnea in Acute Heart Failure Patients
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Purpose
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.
| Condition |
|---|
|
Acute Heart Failure Dyspnea |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Assessment of The Clinical Course of Dyspnea and Its Association With Respiratory Rate in Patients With Acute Heart Failure Syndromes |
- To determine the association between respiratory rate and self-reported dyspnea in AHF patients. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
| Enrollment: | 16 |
| Study Start Date: | June 2012 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Adult patients who present to the Emergency Department with Acute Heart Failure
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
Contacts and Locations| United States, Illinois | |
| Northwestern Memorial Hospital | |
| Chicago, Illinois, United States, 60611 | |
| Principal Investigator: | Peter S Pang, MD | Northwestern University |
More Information
No publications provided
| Responsible Party: | Peter Pang, Associate Professor of Emergency Medicine, Northwestern University |
| ClinicalTrials.gov Identifier: | NCT01615926 History of Changes |
| Other Study ID Numbers: | MSSRP-IC2012 |
| Study First Received: | June 7, 2012 |
| Last Updated: | April 30, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Northwestern University:
|
dyspnea shortness of breath respiratory rate orthopnea |
Additional relevant MeSH terms:
|
Dyspnea Heart Failure Respiration Disorders Respiratory Tract Diseases |
Signs and Symptoms, Respiratory Signs and Symptoms Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013