Study of High-dose Spironolactone vs. Placebo Therapy in Acute Heart Failure (ATHENA-HF)
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|ClinicalTrials.gov Identifier: NCT02235077|
Recruitment Status : Completed
First Posted : September 9, 2014
Results First Posted : May 17, 2017
Last Update Posted : June 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Drug: Spironolactone Drug: Placebo||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||360 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Aldosterone Targeted Neurohormonal Combined With Natriuresis Therapy - HF (ATHENA-HF)|
|Actual Study Start Date :||December 30, 2014|
|Actual Primary Completion Date :||April 12, 2016|
|Actual Study Completion Date :||June 6, 2016|
Active Comparator: Spironolactone
Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours
Patients receiving no MRA at home will receive spironolactone 100 mg (4x25 mg capsules) once daily for 96 hours.
Patients already receiving low-dose MRA at home will be randomized to receive spironolactone 25 mg (1x25 mg capsules) or 100 mg (4x25 mg capsules) in hospital for 96 hours. The patients who are randomized to 25 mg spironolactone will also receive 75 mg placebo (3x25 mg capsules) in order to maintain blinding.
Other Name: aldactone
Placebo Comparator: Placebo
Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours
Patients receiving no MRA at home will receive 100 mg placebo (4x25 mg capsules) once daily for 96 hours.
Patients who are randomized to 25 mg spironolactone will also receive 75 mg placebo (3x25 mg capsules) in order to maintain blinding.
- 96 Hour Change in NT-proBNP [ Time Frame: Randomization to 96 hours ]The Core Laboratory at Vermont will determine NT-proBNP levels for calculation of the endpoint from samples obtained at randomization and 96 hours respectively. NT-proBNP was converted to log scale.
- 96 Hour Change in Clinical Congestion Score [ Time Frame: Randomization through 96 hours ]Clinical congestion score will be assessed at randomization, 96 hours, and at discharge. Scale consisted of sum of six signs and symptoms of congestion, each scored 0-3. Zero indicates no sign/symptom and 3 indicates worst case of sign/symptom. Score range 0-18 with 18 being worst score.
- 96 Hour Change in Dyspnea Likert Score [ Time Frame: Randomization through 96 hours ]Dyspnea relief via 7-point Likert scale will be assessed at randomization, 96 hours, and at discharge. The Likert score was defined as 1=markedly improved, 2=moderately improved, 3=minimally improved; 4=no change, 5=minimally worse, 6=moderately worse, and 7=markedly worse as compared with the degree of dyspnea present at randomization.
- 96 Hour Change in Serum Creatinine [ Time Frame: Randomization through 96 hours ]Renal function via serum creatinine, will be assessed at randomization and daily through 96 hours
- 96 Hour Net Fluid Output [ Time Frame: Randomization through 96 hours ]Fluid intake and urine output will be assessed daily while in hospital through 96 hours. Net fluid output (output minus input) through 96 hours is reported.
- 96 Hour Change in Body Weight [ Time Frame: Randomization through 96 hours or earlier discharge ]Baseline body weight assessment will be completed, and changes in weight documented daily through 96 hours or earlier discharge
- 96 Hour Change in Serum Potassium Levels [ Time Frame: Baseline, 96 hours ]Change in serum potassium levels at 96 hours as compared to baseline.
- Change in Loop Diuretics Requirements From Baseline to 30 Days [ Time Frame: Randomization through Day 30 ]Medications will be reviewed to assess loop diuretic dose requirements through Day 30 following randomization
- Presence of Outpatient Worsening Heart Failure Symptoms Through Day 30 [ Time Frame: Hospital discharge through Day 30 ]Outpatient worsening heart failure symptoms will be assessed from discharge through Day 30
- 96 Hour Change in Dyspnea Visual Analog Scale [ Time Frame: Randomization to 96 hours ]Dyspnea visual analog scale change from randomization to 96 hours. Scale range 0-100 with 100 being the best possible score.
- Day 60 Mortality [ Time Frame: 60 days post randomization ]All participants will be contacted by telephone at 60 days, +/- 3 days post randomization to assess vital status (death).
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): NCT02235077
|United States, Georgia|
|Emory University School of Medicine|
|Atlanta, Georgia, United States, 30322|
|United States, Maryland|
|Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21287|
|United States, Massachusetts|
|Tufts Medical Center|
|Boston, Massachusetts, United States, 02111|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Boston VA Healtcare System|
|West Roxbury, Massachusetts, United States, 02132|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, Missouri|
|Saint Louis, Missouri, United States, 63110|
|Saint Louis University Hospital|
|Saint Louis, Missouri, United States, 63117|
|United States, New York|
|Stony Brook University Medical Center|
|Stony Brook, New York, United States, 11794|
|United States, North Carolina|
|Durham, North Carolina, United States, 27705|
|Southeastern Regional Medical Center|
|Lumberton, North Carolina, United States, 28358|
|United States, Ohio|
|University Hospitals - Case Medical Center|
|Cleveland, Ohio, United States, 44106|
|Metro Health System|
|Cleveland, Ohio, United States, 44109|
|Cleveland, Ohio, United States, 44195|
|United States, Pennsylvania|
|Lancaster General Hospital|
|Lancaster, Pennsylvania, United States, 17603|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Jefferson Medical College|
|Philadelphia, Pennsylvania, United States, 19107|
|United States, Texas|
|Michael Debakey VA Medical Center|
|Houston, Texas, United States, 77030|
|United States, Utah|
|University of Utah School of Medicine|
|Salt Lake City, Utah, United States, 84132|
|Utah VA Medical Center|
|Salt Lake City, Utah, United States, 84132|
|United States, Vermont|
|The University of Vermont- Fletcher Allen Health Care|
|Burlington, Vermont, United States, 05401|
|Principal Investigator:||Adrian Hernandez, MD||Duke University Health Systems|
|Study Chair:||Eugene Braunwald, MD||Harvard University|