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Recruitment Status : Withdrawn (Principal Investigator left institution prior to subjects being enrolled)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
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Drug: Spironolactone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
No Intervention: Usual Care
This arm of the study will continue the usual care of hospitalized acute decompensated heart failure patients with loop diuretics.
- 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.
- 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.
- 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.
- 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.
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
|United States, Texas|
|San Antonio, Texas, United States, 78229|
|Principal Investigator:||Marvin H Eng, M.D.||University of Texas Heatlh Science Center at San Antonio|