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High-Dose Aldactone for Treatment of Diuretic Resistant Heart Failure

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ClinicalTrials.gov Identifier: NCT02429388
Recruitment Status : Withdrawn (Principal Investigator left institution prior to subjects being enrolled)
First Posted : April 29, 2015
Last Update Posted : April 20, 2016
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Brief 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.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: Spironolactone Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High-Dose Aldactone for Treatment of Diuretic Resistant Heart Failure
Study Start Date : May 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High dose spironolactone
This arm of the study will include addition of high dose spironolactone upto 100mg twice daily in adjunct to usual care of hospitalized acute decompensated heart failure patients with loop diuretics.
Drug: Spironolactone
Administration of spironolactone 25-50mg orally twice daily for two days and subsequently titrated upto 100mg twice daily with daily serum potassium monitoring. Spironolactone will continue until patient is euvolemic and appropriate for discharge. Titration of loop diuretics in this arm will not be escalated.
Other Names:
  • aldactone
  • potassium-sparing diuretics

No Intervention: Usual Care
This arm of the study will continue the usual care of hospitalized acute decompensated heart failure patients with loop diuretics.



Primary Outcome Measures :
  1. Efficacy of adjunctive high-dose Spironolactone on weight loss. [ Time Frame: 7 days ]
    Weight will be tracked from enrollment to 7 days or when patient reaches euvolemia for all patients, whichever occurs first.


Secondary Outcome Measures :
  1. Efficacy of adjunctive high-dose Spironolactone on dyspnea. [ Time Frame: 7 days ]
    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.

  2. Risk of hyperkalemia and renal dysfunction with use of adjunctive high-dose Spironolactone. [ Time Frame: 7 days ]
    Assessment of serum potassium and creatinine daily on all patients to assess relative safety of spironolactone use in diuretic resistant heart failure patients.

  3. Length of hospitalization [ Time Frame: 7 days ]
    Comparison of length of hospitalization with use of high dose spironolactone to heart failure therapy compared to usual care.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02429388


Locations
United States, Texas
University Hospital
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
Principal Investigator: Marvin H Eng, M.D. University of Texas Heatlh Science Center at San Antonio

Publications:
Hunt SA, Abraham WT, Chin MH, Feldman AM, Francis GS, Ganiats TG, Jessup M, Konstam MA, Mancini DM, Michl K, Oates JA, Rahko PS, Silver MA, Stevenson LW, Yancy CW, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Halperin JL, Hiratzka LF, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B; American College of Cardiology; American Heart Association Task Force on Practice Guidelines; American College of Chest Physicians; International Society for Heart and Lung Transplantation; Heart Rhythm Society. ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure): developed in collaboration with the American College of Chest Physicians and the International Society for Heart and Lung Transplantation: endorsed by the Heart Rhythm Society. Circulation. 2005 Sep 20;112(12):e154-235. Epub 2005 Sep 13.

Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT02429388     History of Changes
Other Study ID Numbers: HSC20140274H
First Posted: April 29, 2015    Key Record Dates
Last Update Posted: April 20, 2016
Last Verified: April 2016

Keywords provided by The University of Texas Health Science Center at San Antonio:
Heart failure
Spironolactone
Diuretics

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Diuretics
Spironolactone
Sodium Potassium Chloride Symporter Inhibitors
Diuretics, Potassium Sparing
Sodium Channel Blockers
Natriuretic Agents
Physiological Effects of Drugs
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action