GUIDE-IT - GUIDing Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure (GUIDE-IT) -The goal of this US prospective outpatient AF registry is to identify real world treatment patterns in patients with AF(atrial fibrillation), outside of randomized controlled trials. Specifically, the registry will attempt to define current treatment patterns and their relationship with outcomes, including stroke, all-cause mortality, and quality-of-life.

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    Recruiting
Updated on 25 March 2021

Summary

GUIDE-IT - GUIDing Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure (GUIDE-IT) -The goal of this US prospective outpatient AF registry is to identify real world treatment patterns in patients with AF(atrial fibrillation), outside of randomized controlled trials. Specifically, the registry will attempt to define current treatment patterns and their relationship with outcomes, including stroke, all-cause mortality, and quality-of-life.

Description

The purpose of this study is to see if using the results of a blood test called NT-proBNP (a hormone released from the heart also known as a biomarker) can help doctors decide the best drug treatment for patients with heart failure (HF). Approximately 1,100 people will take part in this study at approximately 35 different hospitals and medical facilities. The primary endpoint is time to cardiovascular death or first heart failure hospitalization. Once enrolled in the study there is a minimum of 12 months of follow-up.

Details
Clinical Study IdentifierTX137607
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Hospitalization for ACS defined by
dyspnea at rest or on minimal exertion plus
at least 1 sign of volume overload: elevated jugular venous pulse; pulmonary rates; peripheral edema; congestion on chest x-ray
For the purposes of qualification for the GUIDE-IT study, treatment in the emergency department or observation unit for signs and symptoms of heart failure with intravenous loop diuretics will qualify as a "hospitalization equivalent" provided all other inclusion criteria are met
AND OTHERS

Exclusion Criteria

Acute coronary syndrome of cardiac revascularization prodecure within 30 days (NOTE: Given that cardiac biomarkers such as troponin are frequently elevated in HF patients, the diagnosis of acute coronary syndrome should be based on clinical diagnosis, not biomarkers alone)
Cardiac resynchronization therapy (CRT) within prior three months or current plan to implant CRT device
Active myocarditis, Hypertrophic obstructive cardiomyopathy, pericarditis, or restrictive cardiomyopathy
Severe stenotic valvular disease
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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