Guiding Evidence Based Therapy Using Biomarker Intensified Treatment (GUIDE IT)

Study ID
STU 092012-069

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Lynn Fernandez
214-645-8040
lynn.fernandez@utsouthwestern.edu

Principal Investigator
Mark Drazner

Summary

This study will be a multicenter, prospective, randomized, parallel control group, unblinded, 2-arm multicenter clinical trial comparing biomarker-guided therapy to usual care in patients with systolic HF at high risk for hospitalization or death. There will be about 35 uS centers with an enrollment goal of about 1100 patients.
The study duration will be 5 years with 36 months of active enrollment, 12 months of patient follow up after last patient is enrolled and 6 months of study close-out, data analysis and reporting of results.
Subjects wil be randomized at time of discharge or within a 2 week window after hospital discharge; in a 1:1 fashion to either biomarker-guided therapy or usual care (via iVRS - interactive voice response system).
We plan to enroll 32 patients.
eCHoCaRDioGRaM SuBSTuDY
The optional echocardiogram substudy will be offered to patients already enrolled into the main study.
Resting transthoracic 2-D and Doppler echocardiograms will be performed at the baseline visit and at the12 month visit. if a clinical echocardiogram is performed prior to any procedure that will significantly impact cardiac function, an attempt will be made to obtain this study for analysis. Primary objective of the substudy is to evaluate for change in left ventricular systolic volume index (LVeSVi) over 12 months in heart failure patients treated with nT-proBnP guided therapy compared to those treated with the standard of care. Secondary endpoints - to determine if there is a difference over 12 months betweeen the nT proBnP guided therapy vs standard of care heart failure care for the following echocardiographic parameters: left ventricular systolic function, left ventricaulr diastolic function, right ventricular systolic function, cardiac chamber size and geometry, valvular regurgitation and non invasive hemodynamics. The sub study will also assess echographic predictors for response to medical therapy and clinical events in the nT proBnP guided heart failure group vs the standard heart failure group.

Participant Eligibility

1.) Age greater than or equal to 18 years
2.) Most recent LVEF to be <= 40% by any method within 12 months of randomization.
3.) High risk heart failure as defined by the following criteria
* A heart failure (HF) event in the prior 12 months, defined as any one of the following:
~ HF hospitalization
~ Treatment in the Emergency Department (or equivalent) for heart failure
~ Outpatient treatment for heart failure with intravenous diuretics
AND
* NT proBNP > 2000pg/mL or BNP > 400 pg/mL at any time during the 30 days prior to randomization
4.) Willing to provide informed consent