RAAS Optimization for Acute CHF Patients

NCT03695120 | Completed

• 1 other identifier: IRB201702923
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Decompensated Heart Failure

Keywords

ACEI (Angiotensin-Converting-Enzyme Inhibitor); ARB (Angiotensin II Receptor Blocker); CHF (Congestive Heart Failure); RAAS (Renin Angiotensin Aldosterone System)

Outcome Measures

Primary Outcomes (4)

• Serum Creatinine Levels

  Change in serum creatinine from randomization. (AKI is defined as an increase in the serum creatinine level of more than 0.3 mg per deciliter over 48 hours)

  Baseline, 24 hours, 48 hours, 72 hours

• Patient Global Assessment (well-being) over 72 hours

  Patient global assessments by modified scale (based on Borg and VAS) for 0, 24, 48, 72 hours. Scaled 1 - 10. A "1" means the patient feels the best they've ever felt and a "10" means the participant feels the worst they have ever felt. Following all time points collected, the area under the curve for global assessment over the first 72 hours will be a primary efficacy endpoint (AUC for PGA). For patient well-being (PGA) 1 Best I've ever felt 2 3 Feeling good 4 5 Feeling okay 6 7 Feeling bad 8 9 Feeling terrible 10 Worst I've ever felt

  0 hours, 24 hours, 48 hours, 72 hours

• Dyspnea (shortness of breath) clinical change over 72 hours

  Patient dyspnea assessments by modified scale (based on Borg and VAS) for 0, 24, 48, 72 hours. Scaled 1 - 10. A "1" means no shortness of breath and a "10" means the patient can't breathe at all. Following all time points collected, the area under the curve for dyspnea assessment over the first 72 hours will be a primary efficacy endpoint (AUC for dyspnea). For shortness of breath (SOB) 1 No SOB at all 2 3 Slight SOB 4 5 Moderate SOB 6 7 Severe SOB 8 9 Extreme SOB 10 "I can't breathe!"

  0 hours, 24 hours, 48 hours, 72 hours

• Kinetic EGFR Levels

  Change in kinetic EGFR from baseline to 24, 48, and 72 hours.

  Baseline, 24 hours, 48 hours, 72 hours

Secondary Outcomes (10)

• Weight Change

  Baseline, 24 hours, 48 hours, 72 hours

• Negative Fluid Balance

  Baseline, 24 hours, 48 hours, 72 hours

• CHF Clinical Change

  Baseline, 72 hours

• Change in Renal Function

  Baseline, 48 hours

• Number of patients experiencing CHF Treatment Failure

  Over 72 hours

Study Arms (2)

Full Dose ACEI/ARB or Home Dose Group

NO INTERVENTION

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

No ACEI/ARB Group

ACTIVE COMPARATOR

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

Other: Change of treatment plan

Interventions

Change of treatment plan 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.

No ACEI/ARB Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

UF Health at the University of Florida

Gainesville, Florida, 32610, United States

Location

Related Publications (1)

• 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.

  PMID: 31797310 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Bhagwan Dass, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The subjects will be randomized into a control group or variable group with an approximate 50/50 randomization. The control group will consist of subjects receiving ACEIs/ARBs. The variable group will consist of subjects that will not receive ACEI/ARBs during the first 72 hours of admission.

Study Record Dates

• First Submitted: September 19, 2018
• First Posted: October 3, 2018
• Study Start: February 8, 2019
• Primary Completion: April 12, 2021
• Study Completion: April 12, 2021
• Last Updated: April 22, 2021

Record last verified: 2021-04

Locations

US (1)