Status:
UNKNOWN
Safety and Efficacy of Early, seQUential Oral dIuretic Nephron blockAde In Acute Heart Failure
Lead Sponsor:
University of Parma
Collaborating Sponsors:
Azienda Ospedaliero-Universitaria di Parma
Azienda USL di Parma
Conditions:
Acute Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The SEEQUOIA-AHF (Safety and Efficacy of Early, seQUential oral dIuretic nephron blockAde in Acute Heart Failure) trial is a multicenter, randomized, open-label, parallel-arm trial assessing the impac...
Detailed Description
The SEEQUOIA-AHF trial is aimed at ascertaining if the early, oral administration of a combination of four diuretics with different sites of action along sequential nephron segments (i.e., sequential ...
Eligibility Criteria
Inclusion
- Male or non-pregnant female patient, 18 years or older
- Patients admitted to Cardiology or Internal Medicine units with a diagnosis of acute decompensated heart failure and congestion: NT-proBNP \> 1,000 pg/ml or BNP \>250 pg/ml, dyspnea and at least two of the following clinical signs: 2+ pitting edema, pulmonary edema/pleural effusions at chest x-ray or US body weight increase above usual \> 5% over the last 4 weeks
- Clinically stable patients that can be switched to oral diuretic therapy after 24-72 hours of an algorithm-based treatment with high-dose intravenous furosemide started at the time of hospital admission
- Patients capable to provide written informed consent
Exclusion
- Serum creatinine levels \> 3.5 mg per deciliter at admission to the hospital or usual estimated glomerular filtration rate (eGFR) \< 20 ml/min/1.73 m2 by the MDRD or CKD-EPI formula
- Systolic blood pressure \< 90 mmHg at time of enrollment and/or hemodynamic instability severe enough to require intravenous inotropes, intravenous vasodilators, or both
- Severe arrhythmias with hemodynamic instability or DC shock occurred prior to randomization
- Ascertained acute coronary syndrome (ACS), or ACS occurred within the last 4 weeks
- Hematocrit \> 45%
- Use of iodinated radio contrast material occurred in the last 72 hours
- Current mechanical ventilator support
- Previous solid organ transplant
- Primary hypertrophic or infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis or cardiac tamponade, severe valvular stenosis
- Complex congenital heart disease
- Liver disease (serum ALT or AST \> 4, and/or total serum bilirubin \> 3)
- Known bilateral renal artery stenosis
- Active sepsis or ongoing systemic infection
- Active gastrointestinal tract bleeding
- Enrollment in another clinical trial
- Locally advanced or metastatic cancer
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT04062760
Start Date
December 1 2019
End Date
December 1 2024
Last Update
August 20 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UO Nefrologia, Azienda Ospedaliero-Universitaria di Parma
Parma, PR, Italy, 43126