High-dose Aldosterone Antagonist for Acute Decompensated Heart Failure
Completed
Conditions studied: Acute Decompensated Heart Failure
In brief
Primary Aims 1. Evaluate the safety of high-dose spironolactone in combination of patiromer in acute decompensated heart failure patients. 2. Evaluate the efficacy of high-dose spironolactone in combination of patiromer in causing volume loss and symptom relief in patients with ADHF treated with high-dose spironolactone. Secondary Aims 1: Evaluate the effect of high-dose spironolactone on urinary sodium excretion and renal function.
Key facts
- Study ID
- NCT02823626
- Run by
- The University of Texas Health Science Center at San Antonio
- People needed
- 48
- Starts
- 2016-09-01
- Expected to finish
- 2018-04-01
- Last updated by the study team
- 2019-05-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- More than18 years old
- Hospitalized with history of chronic heart failure and at least one symptom (dyspnea, orthopnea or edema) and one sign (rales, peripheral edema, ascites, or radiographic pulmonary edema or pleural effusion)
- Use of loop diuretics
- Women of child bearing age with negative urine pregnancy test
You may not qualify if…
- Acute coronary syndrome
- Patients with a baseline eGFR < 30 ml/min by MDRD equation
- Baseline potassium concentration ≥ 5.5 mEq/L
- Requirement for intravenous vasodilators or inotropic agents
- Systemic infection
- Patients with concomitant end-stage liver disease
- Hemodynamically significant uncorrected valvular disease
- Patients with pulmonary embolism
- Patients with high output heart failure
- Pregnant patients
Where it is running
- Shweta Bansal — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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