High-Dose Aldactone for Treatment of Diuretic Resistant Heart Failure

• Status: Withdrawn
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Prospective, open-label, randomized cohort study comparing adding high-dose spironolactone to usual heart failure care versus usual care in patients with acute decompensated heart failure. Patients will be randomized in a 1:1 fashion to either usual care or high-dose spironolactone plus usual care. Both arms of the study will continue with treatment of ADHF until euvolemia as defined as the resolution of pulmonary edema, peripheral edema, abdominal bloating and/or jugular venous distention. Assessment of clinical status and serum electrolytes, symptoms and renal function will be performed in accordance to standard of care.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center at San Antonio
• Treatments: Diuretics; Diuretics, Potassium Sparing; Sodium Channel Blockers; Sodium Potassium Chloride Symporter Inhibitors; Spironolactone

Criteria

Inclusion Criteria:

1. 18 years or older patients with congestive heart failure

2. Hypervolemic by at least 2 of the following criteria: 1) Peripheral edema; 2) jugular venous distention greater than 7 cm; 3) radiographic pulmonary edema or pleural effusion; 4) enlarged liver or ascites; 5) pulmonary rales, paroxysmal nocturnal dyspnea or orthopnea

3. Diuretic resistance as defined by loop diuretic requirements of furosemide greater or equal to 160 mg IV total daily dose or equivalent dose of torsemide or bumetanide. ( 1 mg bumetanide = 10 mg torsemide = 20 mg furosemide)

4. Estimated glomerular filtration rate (eGFR) of > 30ml/min. according to the MDRD Study equation at the time of admission.

5. Female patients of child bearing potential must have a negative urine pregnancy test to be eligible.

Exclusion Criteria:

1. Acute coronary syndrome

2. Patients with a baseline eGFR < 30 ml/min according to the MDRD equation.

3. Baseline potassium serum concentration 5.3 meq/L

4. Requirement for intravenous pressors

5. Systemic infection

6. Patients with concomitant end-stage liver disease

7. Significant valvular disease

8. Patients with pulmonary embolism

9. Patients with high output heart failure

10. Pregnant patients