High-dose Aldosterone Antagonist for Acute Decompensated Heart Failure

• Status: Completed
• Trial end date: 2018-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborator: Relypsa, Inc.
• Treatments: Mineralocorticoid Receptor Antagonists; Spironolactone

Criteria

Inclusion Criteria:

1. More than18 years old

2. 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)

3. Use of loop diuretics

4. Women of child bearing age with negative urine pregnancy test

Exclusion Criteria:

1. Acute coronary syndrome

2. Patients with a baseline eGFR < 30 ml/min by MDRD equation

3. Baseline potassium concentration ≥ 5.5 mEq/L

4. Requirement for intravenous vasodilators or inotropic agents

5. Systemic infection

6. Patients with concomitant end-stage liver disease

7. Hemodynamically significant uncorrected valvular disease

8. Patients with pulmonary embolism

9. Patients with high output heart failure

10. Pregnant patients