Guiding Evidence Based Therapy Using Biomarker Intensified Treatment (GUIDE IT)
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.
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.
1.) Age greater than or equal to 18 years
2.) Hospitalization for acute decompensated HF, manifest 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[Single Quote] provided all other inclusion criteria are
3.) Most recent documented LVEF to be <= 40% by any method within 12 months of randomization. This assessment must occur at least 12 weeks after any intervention likely to improve ejection fraction (e.g., cardiac resynchronization therapy, initiation of beta-blocker therapy, or revascularization).
4.) NT-ProBNP > 2000 pg/mL at least once during index hospitalization. If NT proBNP is not clinically available at the facility where the index hospitalization occurs, then an equivalent of BNP level of > 400pg/mL at least once during the index hospitalization will be an acceptable alternative for the purposes of qualifying for enrollment in the study.
5.) Willing to provide informed consent