RAAS Optimization for Acute CHF Patients

NCT ID: NCT03695120

Last Updated: 2021-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-08
• Study Completion Date: 2021-04-12

Brief Summary

Holding ACEI/ARBs during initial 72 hours of admission with acute decompensated heart failure may help preserve renal function with a lesser decline in GFR. This treatment modification will also allow the option of aggressive diuresis in volume overloaded CHF patients which should result in a lesser decline of AKI, length of stay, readmission rates, and cost associated with CHF treatment.

Detailed Description

The investigators hypothesize that worsening renal function can be mitigated by withholding ACEI/ARB during the initial phase of in-patient treatment with aggressive diuresis. This hypothesis will be tested by randomly allocating 360 admitted patients with ADHF on two treatment paths: 1) no ACEI/ARB administered for initial 72 hours of treatment during aggressive diuresis versus 2) full dose ACEI/ARB administered concurrently with aggressive diuresis in naïve patients/home dose, who are already on such therapy. The study team hopes to find that holding ACEI/ARBs during the initial 72 hours of admission with acute decompensated systolic heart failure will help preserve renal function, as demonstrated by a lesser decline in GFR. In addition, this treatment would allow the option of aggressive diuresis in volume overloaded CHF patients, resulting in a lesser decline of AKI, length of stay, readmission rates, and costs associated with CHF treatment. By understanding the complex interaction between holding ACEIs/ARBs and continued aggressive diuresis, the investigators intend to develop optimal dosing strategies for acute, decompensated CHF patients, further minimizing adverse events such as electrolyte issues and declining GFR/AKI.

Conditions

Acute Decompensated Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Full Dose ACEI/ARB or Home Dose Group

This group will receive the full dose of ACEI/ARBs.

Group Type: NO_INTERVENTION

No interventions assigned to this group

No ACEI/ARB Group

This group will not receive the full dose of ACEI/ARBs for the first 72 hours of hospitalization.

Group Type: ACTIVE_COMPARATOR

Change of treatment plan

Intervention Type: OTHER

Withholding ACEI/ARBs during initial 72 hours of admission with acute decompensated heart failure may help preserve renal function with a lesser decline in GFR. This treatment modification will also allow the option of aggressive diuresis in volume overloaded CHF patients which should result in a lesser decline of AKI, length of stay, readmission rates, and cost associated with CHF treatment.

Interventions

Change of treatment plan

Withholding ACEI/ARBs during initial 72 hours of admission with acute decompensated heart failure may help preserve renal function with a lesser decline in GFR. This treatment modification will also allow the option of aggressive diuresis in volume overloaded CHF patients which should result in a lesser decline of AKI, length of stay, readmission rates, and cost associated with CHF treatment.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Patients are eligible for enrollment if within the previous 24 hours they were treated with acute decompensated heart failure or diagnosed on the basis of the investigator's clinical diagnosis of heart failure, which needs to be supported by at least 2 the following criteria:

• Elevated concentration of B-type natriuretic peptide (BNP) or N-terminal pro-BNP. (Elevated BNP" defined as >300 for sinus rhythm, >500 for patients will atrial fibrillation and elevated pro BNP defined as >1000 for sinus rhythm, >1600 for atrial fibrillation.)
• Pulmonary edema on physical examination.
• Radiologic pulmonary congestion or edema.
• History of Chronic Heart Failure. Anticipated need for IV loop diuretics for at least 48 hours
• Willingness to provide informed consent

Exclusion Criteria

• Previously diagnosed end-stage renal disease; Serum Potassium >5.5 mmol/L
• Cardiogenic Shock within 48 hours, ST-segment elevation myocardial infarction, ongoing ischemia.
• Need for renal replacement therapy through dialysis or ultrafiltration
• Myocardial infarction within 30 days of screening.
• Patients with systolic blood pressure of less than 90 mm Hg.
• Patients requiring Intravenous Vasodilators or inotropic agents (other than Digoxin) for heart failure
• BNP less than 250 ng/ml and/or proBNP less than 1000 mg/ml
• Pregnant women, prisoners, and institutionalized individuals
• Severe stenotic valvular disease
• Complex congenital heart disease
• Need for mechanical hemodynamic support
• Sepsis
• Terminal illness (other than HF) with expected survival of less than one year
• Previous adverse reaction to the study drugs
• Use of IV iodinated radiocontrast material in last 72 hours or planned during hospitalization
• Enrollment or planned enrollment in another randomized clinical trial during this hospitalization
• Inability to comply with planned study procedures
• Primary admission diagnosis other than acute heart failure

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bhagwan Dass, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

UF Health at the University of Florida

Gainesville, Florida, United States

Countries

United States

References

Dass B, Dimza M, Singhania G, Schwartz C, George J, Bhatt A, Radhakrishnan N, Bansari A, Bozorgmehri S, Mohandas R. Renin-Angiotensin-Aldosterone System Optimization for Acute Decompensated Heart Failure Patients (ROAD-HF): Rationale and Design. Am J Cardiovasc Drugs. 2020 Aug;20(4):373-380. doi: 10.1007/s40256-019-00389-7.

Reference Type: DERIVED

PMID: 31797310 (View on PubMed)

Other Identifiers

IRB201702923

Identifier Type: -

Identifier Source: org_study_id