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Renin-Angiotensin-Aldosterone System Optimization for Acute Decompensated Heart Failure Patients (ROAD-HF): Rationale
Bhagwan Dass1,2, Michelle Dimza3, Girish Singhania4
1Division of Hospital Medicine, University of Florida, PO Box 100238, Gainesville, FL, 32610, USA. Bhagwan.Dass@medicine.ufl.edu.
Insights
Withholding angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) during acute decompensated heart failure (ADHF) may prevent worsening renal function. This strategy could improve outcomes and reduce healthcare costs for ADHF patients.
Area of Science:
- Cardiology
- Nephrology
- Clinical Trials
Background:
- Angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) are vital for chronic heart failure but pose risks in acute decompensated heart failure (ADHF).
- Worsening renal function (WRF) in ADHF patients treated with ACEIs/ARBs is linked to increased mortality.
- Decreased estimated glomerular filtration rate (eGFR) during ADHF treatment correlates with mortality risk.
Purpose of the Study:
- To evaluate if temporarily withholding ACEIs/ARBs for 72 hours in ADHF patients prevents WRF.
- To determine if this withholding strategy allows for more effective diuresis.
- To assess the impact on acute kidney injury (AKI) rates and overall patient outcomes.
Main Methods:
- A prospective randomized trial involving 430 ADHF patients.
- Patients randomized to either withhold ACEIs/ARBs or continue/start them for 72 hours.
- Primary outcomes: AKI rates, patient global assessment, and change in eGFR; secondary outcomes include weight, fluid balance, congestion, renal function, biomarkers, treatment failure, length of stay, cost, and mortality.
Main Results:
- This section is to be filled once the trial results are available.
- The study is designed to provide definitive data on the primary and secondary outcomes.
- Results will elucidate the impact of ACEI/ARB withdrawal on renal function and clinical outcomes in ADHF.
Conclusions:
- This clinical trial aims to determine if withholding ACEIs/ARBs prevents AKI in ADHF.
- Findings will clarify the heart-kidney interactions and optimal ADHF management strategies.
- Potential benefits include preserved renal function, reduced hospital length of stay, readmissions, and healthcare costs.
Introduction:
The long-term benefits of angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) on outcomes in patients with chronic congestive heart failure are well-known, making them one of the most widely prescribed medications. However, the administration of ACEIs/ARBs in acute decompensated heart failure (ADHF) can increase the risk of morbidity and mortality secondary to worsening renal function (WRF). A decrease in estimated glomerular filtration rate (eGFR) during the treatment of ADHF has been associated with an increase in mortality proportional to the degree of WRF.
Aim:
The aim of our study is to determine whether withholding ACEIs/ARBs during the initial 72 h of admission in patients with ADHF will prevent WRF and allow more effective diuresis.
Methods:
Four hundred and thirty patients will be randomized to the intervention (withholding ACEIs/ARBs) or control (continue/start ACEIs/ARBs) arms for 72 h. Primary outcomes include rates of acute kidney injury (AKI), patient global assessment, and change in kinetic eGFR over 72 h, while secondary outcomes include change in weight, fluid balance, change in signs and symptoms of congestion, change in renal function, change in urinary biomarkers (tissue inhibitor of metalloproteinases 2 [TIMP-2] × insulin-like growth factor-binding protein 7 [IGFBP7]), patients experiencing treatment failure, hospital length of stay (LOS), cost analysis, mortality within 30 days, and hospital readmissions over 30 days and 1 year.
Conclusion:
This prospective clinical trial will prove if withholding ACEIs/ARBs will prevent AKI in ADHF. It will help us understand the complex interactions between the heart and kidney, and delineate the best treatment strategy for ADHF. Holding ACEIs/ARBs might help preserve renal function, and decrease hospital LOS, readmission rates, and cost of care in ADHF.
Registration:
ClinicalTrials.gov identifier: NCT03695120.
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