Acute Decompensated Heart FailureROAD-HFNCT03695120
RAAS Optimization for Acute CHF Patients
A study testing Change of treatment plan in people with Acute Decompensated Heart Failure, run by University of Florida at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Decompensated Heart Failure
- What is being tested?
- Change of treatment plan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2019to 12 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UF Health at the University of Florida
Gainesville, Florida, 32610
About this study
Official title: Renin Angiotensin Aldosterone Optimization in Acute Decompensated Heart Failure
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.
Read the 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
- Being tested
- Change of treatment plan
- Keywords
- ACEI (Angiotensin-Converting-Enzyme Inhibitor), ARB (Angiotensin II Receptor Blocker), CHF (Congestive Heart Failure), RAAS (Renin Angiotensin Aldosterone System)
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Change of treatment planOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Change of treatment plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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!"
Measured: 0 hours, 24 hours, 48 hours, 72 hours
Kinetic EGFR Levels
Change in kinetic EGFR from baseline to 24, 48, and 72 hours.
Measured: Baseline, 24 hours, 48 hours, 72 hours
Secondary outcomes (10)
Weight Change
Change in patient's weight over 3 day period.
Measured: Baseline, 24 hours, 48 hours, 72 hours
Negative Fluid Balance
Changes in net fluid loss over 24, 48, 72 hours.
Measured: Baseline, 24 hours, 48 hours, 72 hours
CHF Clinical Change
Change in signs and symptoms of congestion (defined as jugular venous pressure of <8 cm, with no orthopnea and with trace peripheral edema or no edema) from baseline to 24, 48, 72 hours.
Measured: Baseline, 72 hours
Change in Renal Function
Renal biomarker (NephroCheck) levels at baseline and 48 hours. All patients receive baseline NephroCheck, and 48 hour re-assessment is limited to the first 100 patients.
Measured: Baseline, 48 hours
Number of patients experiencing CHF Treatment Failure
Persistent or worsening heart failure requiring additional interventions. Patients requiring other intravenous vasoactive medications for heart failure (inotropes, vasodilators, etc) for clinical reasons during the randomization period will meet the secondary endpoints of "worsening or persistent heart failure" and "treatment failure."
Patients deemed to have a clinical need for additional diuretics during the study period will be permitted to receive diuretics. This will be captured as "rescue therapy" and will meet criteria for secondary endpoints of "worsening or persistent heart failure" and "treatment failure" endpoints.
Conversely, patients may develop signs or symptoms of over-diuresis (such as hypotension) that will necessitate holding or discontinuing diuretics before completion of the randomization period. This will be captured as a "treatment failure" if it requires specific intervention beyond simply holding diuretics.
Measured: Over 72 hours
Hospitalization LOS
Length of inpatient stay
Measured: Total stay during current admission
Cost Analysis
Cost of inpatient stay during admission.
Measured: Total stay during current admission
Number of patient mortality
Death within 30 days of current inpatient stay (from first day of admission)
Measured: 30 days
Number of patients readmitted or experiencing a ED visit
Readmission or ED visit at UF Health within 30 days of current inpatient stay (from first day of admission)
Measured: 30 days
Number of patients readmitted over one year
Readmission at UF Health within 1 year of current inpatient stay (from first day of admission)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start8 Feb 2019
- Primary completion12 Apr 2021
- Study completion12 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Decompensated Heart FailureStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bhagwan Dass, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03695120
- Sponsor's protocol ID
- IRB201702923
- Acronym
- ROAD-HF
- Status last verified
- Apr 2021
- First submitted
- 19 Sep 2018
- Last updated
- 22 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31797310
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renin Angiotensin Aldosterone Optimization in Acute Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT03695120
- Acronym / sponsor ID
- ROAD-HF / IRB201702923
- 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)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 8 Feb 2019 (actual)
- Primary completion
- 12 Apr 2021 (actual)
- Study completion
- 12 Apr 2021 (actual)
- First posted
- 3 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Change of treatment planThis group will not receive the full dose of ACEI/ARBs for the first 72 hours of hospitalization. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Change of treatment planWithholding 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. | Other | No ACEI/ARB Group |
Primary outcome
Serum Creatinine Levels
Time frame: Baseline, 24 hours, 48 hours, 72 hours
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)
Patient Global Assessment (well-being) over 72 hours
Time frame: 0 hours, 24 hours, 48 hours, 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
Dyspnea (shortness of breath) clinical change over 72 hours
Time frame: 0 hours, 24 hours, 48 hours, 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!"
Kinetic EGFR Levels
Time frame: Baseline, 24 hours, 48 hours, 72 hours
Change in kinetic EGFR from baseline to 24, 48, and 72 hours.
10 secondary outcomes
Weight Change
Time frame: Baseline, 24 hours, 48 hours, 72 hours
Negative Fluid Balance
Time frame: Baseline, 24 hours, 48 hours, 72 hours
CHF Clinical Change
Time frame: Baseline, 72 hours
Change in Renal Function
Time frame: Baseline, 48 hours
Number of patients experiencing CHF Treatment Failure
Time frame: Over 72 hours
Hospitalization LOS
Time frame: Total stay during current admission
Cost Analysis
Time frame: Total stay during current admission
Number of patient mortality
Time frame: 30 days
Number of patients readmitted or experiencing a ED visit
Time frame: 30 days
Number of patients readmitted over one year
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2021.
- Derived from this study: PubMed 31797310Dass 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.
Related trials for Acute Decompensated Heart Failure
Recruiting
Low Level Tragus Stimulation in Acute Decompensated Heart Failure
Acute Decompensated Heart Failure
Recruiting
Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II) (IDE-G210258)
Acute Decompensated Heart Failure
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingObservational study
Clinical Evaluation of NIRSense Tissue Oximetry Sensor Monitoring to Early Detect Cardiogenic Shock
Cardiogenic Shock, Acute Myocardial Infarction
RecruitingPhase 3
A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients
Heart Failure, Acute Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bhagwan Dass, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Change of treatment plan in people with Acute Decompensated Heart Failure, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Creatinine Levels (time frame: Baseline, 24 hours, 48 hours, 72 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03695120, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2021.