Handheld Ultrasound Evaluation of the Inferior Vena Cava to Guide Heart Failure Treatment
Stopped early · Not applicable · Has a placebo group
Conditions studied: Heart Failure
In brief
The purpose of this study is to see if using a portable handheld ultrasound to guide diuretic therapy for heart failure patients will prevent hospital readmissions. This study will use a handheld ultrasound called a Vscan to look at a large vessel in the body called the Inferior Vena Cava (a vein leading to your heart) . The study aims to see whether changing diuretic therapy based on the size of this vessel will result in the less hospitalizations for heart failure patients as compared to just symptom guided therapy. This study is composed of two independent non-interacting trials-one in the outpatient setting and one in the inpatient setting.
Key facts
- Study ID
- NCT01962688
- Run by
- Icahn School of Medicine at Mount Sinai
- People needed
- 37
- Starts
- 2013-08-01
- Expected to finish
- 2015-12-01
- Last updated by the study team
- 2018-06-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with a diagnosis of congestive heart failure
- NYHA class II-IV (ambulatory only)
- left ventricular systolic dysfunction with ejection fraction (EF) < 50%
- history of hospitalization for heart failure within the last year (ambulatory only)
- age >18 years old
- admission to heart failure service (inpatient arm only)
You may not qualify if…
- Patients with dyspnea not mainly due to heart failure
- valvular disease requiring surgery
- acute coronary syndromes within the previous 10 days
- revascularization within the previous month
- body mass index higher than 35
- serum creatinine level higher than 2.49 mg/dL
- a life expectancy of less than 3 years from noncardiovascular diseases (ambulatory arm only)
- a life expectancy of less than 1 year from noncardiovascular disease (inpatient arm only)
- non-cardiovascular causes of acute renal failure present on admission that preclude the use of diuretics (inpatient arm only)
- unable to give informed consent
- no follow-up possible
- participating in another study
Where it is running
- Icahn School of Medicine at Mount Sinai — New York, New York, United States
Full record on ClinicalTrials.gov
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