Heart Failure Clinical Trial
Official title:
High-Dose Aldactone for Treatment of Diuretic Resistant Heart Failure
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | October 2015 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University Hospital | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center at San Antonio |
United States,
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* Note: There are 28 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy of adjunctive high-dose Spironolactone on weight loss. | Weight will be tracked from enrollment to 7 days or when patient reaches euvolemia for all patients, whichever occurs first. | 7 days | No |
Secondary | Efficacy of adjunctive high-dose Spironolactone on dyspnea. | Using Likert scale, dyspnea and functional status will be assessed at enrollment and re-evaluate at 7days or at euvolemia for all patients, whichever occurs first. | 7 days | No |
Secondary | Risk of hyperkalemia and renal dysfunction with use of adjunctive high-dose Spironolactone. | Assessment of serum potassium and creatinine daily on all patients to assess relative safety of spironolactone use in diuretic resistant heart failure patients. | 7 days | Yes |
Secondary | Length of hospitalization | Comparison of length of hospitalization with use of high dose spironolactone to heart failure therapy compared to usual care. | 7 days | Yes |
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