Status:
WITHDRAWN
Early Aldosterone Blockade in Acute Heart Failure: An Exploratory Safety Study
Lead Sponsor:
Indiana University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Vanderbilt University
Conditions:
Acute Heart Failure
Eligibility:
All Genders
22+ years
Phase:
PHASE2
Brief Summary
Over one million hospitalizations for acute heart failure (AHF) occur over every year in the United States, resulting in high mortality, re-hospitalizations, and incurred financial costs; yet nearly e...
Detailed Description
This clinical trial pilot study - Early Aldosterone Blockade in Acute Heart Failure: An Exploratory Safety Study - will explore the safety of early mineralocorticoid receptor blockade with high-dose s...
Eligibility Criteria
Inclusion
- • Male or female, age ≥ 21 years
- Primary reason for admission is acute heart failure requiring IV loop diuretic therapy either in the emergency department (ED) or within 6 hours after direct hospital admission.
- Enrolled within 12 hours of first dose of IV loop diuretic therapy
- BNP \> 300 pg/mL and/or NT-ProBNP \> 1200 pg/mL by local laboratory
- At least 1 of the following: Jugular Venous Distention, Peripheral edema, Radiographic evidence of pulmonary congestion
- Ejection Fraction ≤ 40% within past 12 months by any method
- Able to take oral medications
- Able to provide written informed consent
- Agrees to a minimum of 3 blood draws up to 72 hours from randomization
Exclusion
- • Potassium ≥ 4.8mEq
- eGFR (by sMDRD) \< 45 ml/min/1.73 m2 or a worsening by 50% or more compared to any measurement in the last 6 months or planned ultrafiltration
- History of or planned organ transplantation of any kind within the next 90 days
- Invasive mechanical ventilatory support (non-invasive positive pressure ventilation is allowed)
- Cardiogenic shock and/or treatment or planned treatment with inotropic or vasopressor medications (e.g. dobutamine, dopamine, milrinone, norepinephrine) or intra-aortic balloon pump
- Refractory, end-stage HF defined as subjects who are appropriate candidates for specialized treatment strategies, such as transplant, ventricular assist devices, continuous intravenous inotropic therapy, or hospice care
- Co-morbid condition with an expected survival \<6 months or active cancer
- History of stroke, cardiac surgery, or ACS currently or within past 60 days
- Temperature ≥101.5 degrees F
- Severe valvular or liver disease
- On digoxin or history of MRA allergy or adverse drug reaction
- Women who are currently pregnant or report a recent pregnancy (last 60 days) or plan on becoming pregnant during the next 4 months
- Participation in another drug or device trial in which the last dose of drug was within the past 30 days or an investigational medical device has been implanted
Key Trial Info
Start Date :
May 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02299726
Start Date
May 1 2015
End Date
November 1 2018
Last Update
April 21 2017
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