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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
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Heart Failure
Interventions Drug: Spironolactone
Drug: Placebo
Enrollment 360
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Spironolactone Placebo
Hide Arm/Group Description

Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours

Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.

Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours.

Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours

Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.

Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours.

Period Title: Overall Study
Started 182 178
Completed 164 159
Not Completed 18 19
Reason Not Completed
Death             5             7
Lost to Follow-up             5             6
Withdrawal by Subject             8             5
Physician Decision             0             1
Arm/Group Title Spironolactone Placebo Total
Hide Arm/Group Description

Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours

Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.

Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours.

Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours

Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.

Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours.

Total of all reporting groups
Overall Number of Baseline Participants 182 178 360
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 182 participants 178 participants 360 participants
65.9  (13.7) 63.5  (14.4) 64.7  (14.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 182 participants 178 participants 360 participants
Female
65
  35.7%
64
  36.0%
129
  35.8%
Male
117
  64.3%
114
  64.0%
231
  64.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 182 participants 178 participants 360 participants
Hispanic or Latino
2
   1.1%
6
   3.4%
8
   2.2%
Not Hispanic or Latino
180
  98.9%
172
  96.6%
352
  97.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 182 participants 178 participants 360 participants
American Indian or Alaska Native
3
   1.6%
1
   0.6%
4
   1.1%
Asian
3
   1.6%
1
   0.6%
4
   1.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
74
  40.7%
77
  43.3%
151
  41.9%
White
101
  55.5%
99
  55.6%
200
  55.6%
More than one race
1
   0.5%
0
   0.0%
1
   0.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title 96 Hour Change in NT-proBNP
Hide Description 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.
Time Frame Randomization to 96 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spironolactone Placebo
Hide Arm/Group Description:

Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours

Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.

Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours.

Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours

Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.

Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours.

Overall Number of Participants Analyzed 182 178
Mean (Standard Deviation)
Unit of Measure: log pg/ml
-0.58  (0.69) -0.61  (0.72)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Spironolactone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5688
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.05
Confidence Interval (2-Sided) 95%
-0.11 to 0.20
Estimation Comments [Not Specified]
2.Secondary Outcome
Title 96 Hour Change in Clinical Congestion Score
Hide Description 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.
Time Frame Randomization through 96 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spironolactone Placebo
Hide Arm/Group Description:

Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours

Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.

Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours.

Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours

Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.

Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours.

Overall Number of Participants Analyzed 182 178
Mean (Standard Deviation)
Unit of Measure: units on a scale
-5.59  (3.34) -5.82  (3.32)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Spironolactone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4155
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.25
Confidence Interval (2-Sided) 95%
-0.35 to 0.86
Estimation Comments [Not Specified]
3.Secondary Outcome
Title 96 Hour Change in Dyspnea Likert Score
Hide Description 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.
Time Frame Randomization through 96 hours
Hide Outcome Measure Data
Hide Analysis Population Description
All data for completed assessments was analyzed. For outcomes where the number of participants analyzed is less than 182 spironolactone / 178 placebo, the number of subjects analyzed represents the number of subjects for whom the data was collected.
Arm/Group Title Spironolactone Placebo
Hide Arm/Group Description:

Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours

Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.

Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours.

Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours

Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.

Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours.

Overall Number of Participants Analyzed 166 163
Measure Type: Count of Participants
Unit of Measure: Participants
Markedly improved
64
  38.6%
79
  48.5%
Moderately improved
56
  33.7%
39
  23.9%
Minimally improved
24
  14.5%
18
  11.0%
No change
17
  10.2%
21
  12.9%
Minimally worse
4
   2.4%
5
   3.1%
Moderately worse
0
   0.0%
0
   0.0%
Markedly worse
1
   0.6%
1
   0.6%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Spironolactone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3039
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.23
Confidence Interval (2-Sided) 95%
0.83 to 1.81
Estimation Comments [Not Specified]
4.Secondary Outcome
Title 96 Hour Change in Serum Creatinine
Hide Description Renal function via serum creatinine, will be assessed at randomization and daily through 96 hours
Time Frame Randomization through 96 hours
Hide Outcome Measure Data
Hide Analysis Population Description
All data for completed assessments was analyzed. For outcomes where the number of participants analyzed is less than 182 spironolactone / 178 placebo, the number of subjects analyzed represents the number of subjects for whom the data was collected.
Arm/Group Title Spironolactone Placebo
Hide Arm/Group Description:

Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours

Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.

Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours.

Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours

Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.

Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours.

Overall Number of Participants Analyzed 100 101
Mean (Standard Deviation)
Unit of Measure: mg/dl
0.15  (0.30) 0.16  (0.30)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Spironolactone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7673
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.01
Confidence Interval (2-Sided) 95%
-0.09 to 0.07
Estimation Comments [Not Specified]
5.Secondary Outcome
Title 96 Hour Net Fluid Output
Hide Description 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.
Time Frame Randomization through 96 hours
Hide Outcome Measure Data
Hide Analysis Population Description
All data for completed assessments was analyzed. For outcomes where the number of participants analyzed is less than 182 spironolactone / 178 placebo, the number of subjects analyzed represents the number of subjects for whom the data was collected.
Arm/Group Title Spironolactone Placebo
Hide Arm/Group Description:

Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours

Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.

Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours.

Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours

Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.

Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours.

Overall Number of Participants Analyzed 87 96
Mean (Standard Deviation)
Unit of Measure: ml
5824  (4007) 5507  (3633)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Spironolactone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5734
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 319.2
Confidence Interval (2-Sided) 95%
-797.4 to 1435.8
Estimation Comments [Not Specified]
6.Secondary Outcome
Title 96 Hour Change in Body Weight
Hide Description Baseline body weight assessment will be completed, and changes in weight documented daily through 96 hours or earlier discharge
Time Frame Randomization through 96 hours or earlier discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spironolactone Placebo
Hide Arm/Group Description:

Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours

Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.

Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours.

Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours

Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.

Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours.

Overall Number of Participants Analyzed 182 178
Mean (Standard Deviation)
Unit of Measure: pounds
-8.1  (10.7) -7.5  (9.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Spironolactone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3528
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.02
Confidence Interval (2-Sided) 95%
-3.05 to 1.01
Estimation Comments [Not Specified]
7.Secondary Outcome
Title 96 Hour Change in Serum Potassium Levels
Hide Description Change in serum potassium levels at 96 hours as compared to baseline.
Time Frame Baseline, 96 hours
Hide Outcome Measure Data
Hide Analysis Population Description
All data for completed assessments was analyzed. For outcomes where the number of participants analyzed is less than 182 spironolactone / 178 placebo, the number of subjects analyzed represents the number of subjects for whom the data was collected.
Arm/Group Title Spironolactone Placebo
Hide Arm/Group Description:

Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours

Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.

Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours.

Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours

Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.

Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours.

Overall Number of Participants Analyzed 99 101
Mean (Standard Deviation)
Unit of Measure: mEq/L
0.31  (0.54) 0.15  (0.69)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Spironolactone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0846
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.11
Confidence Interval (2-Sided) 95%
-0.02 to 0.25
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change in Loop Diuretics Requirements From Baseline to 30 Days
Hide Description Medications will be reviewed to assess loop diuretic dose requirements through Day 30 following randomization
Time Frame Randomization through Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
All data for completed assessments was analyzed. For outcomes where the number of participants analyzed is less than 182 spironolactone / 178 placebo, the number of subjects analyzed represents the number of subjects for whom the data was collected.
Arm/Group Title Spironolactone Placebo
Hide Arm/Group Description:

Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours

Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.

Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours.

Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours

Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.

Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours.

Overall Number of Participants Analyzed 164 158
Mean (Standard Deviation)
Unit of Measure: mg
19.66  (69.95) 30.70  (68.29)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Spironolactone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0842
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -12.17
Confidence Interval (2-Sided) 95%
-25.98 to 1.65
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Presence of Outpatient Worsening Heart Failure Symptoms Through Day 30
Hide Description Outpatient worsening heart failure symptoms will be assessed from discharge through Day 30
Time Frame Hospital discharge through Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
All data for completed assessments was analyzed. For outcomes where the number of participants analyzed is less than 182 spironolactone / 178 placebo, the number of subjects analyzed represents the number of subjects for whom the data was collected.
Arm/Group Title Spironolactone Placebo
Hide Arm/Group Description:

Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours

Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.

Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours.

Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours

Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.

Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours.

Overall Number of Participants Analyzed 166 163
Measure Type: Count of Participants
Unit of Measure: Participants
19
  11.4%
17
  10.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Spironolactone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7628
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.11
Confidence Interval (2-Sided) 95%
0.56 to 2.23
Estimation Comments [Not Specified]
10.Secondary Outcome
Title 96 Hour Change in Dyspnea Visual Analog Scale
Hide Description Dyspnea visual analog scale change from randomization to 96 hours. Scale range 0-100 with 100 being the best possible score.
Time Frame Randomization to 96 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spironolactone Placebo
Hide Arm/Group Description:

Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours

Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.

Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours.

Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours

Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.

Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours.

Overall Number of Participants Analyzed 182 178
Mean (Standard Deviation)
Unit of Measure: units on a scale
17.2  (25.0) 17.9  (24.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Spironolactone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6102
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.04
Confidence Interval (2-Sided) 95%
-5.02 to 2.95
Estimation Comments [Not Specified]
11.Other Pre-specified Outcome
Title Day 60 Mortality
Hide Description All participants will be contacted by telephone at 60 days, +/- 3 days post randomization to assess vital status (death).
Time Frame 60 days post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spironolactone Placebo
Hide Arm/Group Description:

Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours

Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.

Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours.

Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours

Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.

Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours.

Overall Number of Participants Analyzed 182 178
Measure Type: Count of Participants
Unit of Measure: Participants
8
   4.4%
10
   5.6%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Spironolactone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5818
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.76
Confidence Interval (2-Sided) 95%
0.29 to 1.99
Estimation Comments [Not Specified]
Time Frame Adverse event data was collected by the sites from randomization through 30 days, but was not collected on the case report form. Only Serious Adverse Events were collected on the data forms.
Adverse Event Reporting Description Adverse event data was collected by the sites from randomization through 30 days, but was not collected on the case report form.
 
Arm/Group Title Spironolactone Placebo
Hide Arm/Group Description

Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours

Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.

Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours.

Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours

Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.

Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours.

All-Cause Mortality
Spironolactone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   5/182 (2.75%)      7/178 (3.93%)    
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Spironolactone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/182 (11.54%)      13/178 (7.30%)    
Blood and lymphatic system disorders     
Anaemia  1  1/182 (0.55%)  1 0/178 (0.00%)  0
Cardiac disorders     
Aortic valve stenosis  1  1/182 (0.55%)  1 0/178 (0.00%)  0
Cardiogenic shock  1  1/182 (0.55%)  1 0/178 (0.00%)  0
Gastrointestinal disorders     
Gastrointestinal Haemmorhage  1  1/182 (0.55%)  1 0/178 (0.00%)  0
Protalgia  1  1/182 (0.55%)  1 0/178 (0.00%)  0
General disorders     
Multi-organ failure  1  1/182 (0.55%)  1 0/178 (0.00%)  0
Non-cardiac chest pain  1  1/182 (0.55%)  1 0/178 (0.00%)  0
Systemic inflammatory response syndrome  1  1/182 (0.55%)  1 0/178 (0.00%)  0
Infections and infestations     
H1N1 Influenza  1  1/182 (0.55%)  1 0/178 (0.00%)  0
Oesophageal Candidiasis  1  0/182 (0.00%)  0 1/178 (0.56%)  1
Pneumonia  1  3/182 (1.65%)  3 1/178 (0.56%)  1
Tooth abscess  1  0/182 (0.00%)  0 1/178 (0.56%)  1
Urinary tract infection  1  1/182 (0.55%)  1 0/178 (0.00%)  0
Injury, poisoning and procedural complications     
Fall  1  1/182 (0.55%)  1 1/178 (0.56%)  1
Post-procedural haemotoma  1  0/182 (0.00%)  0 1/178 (0.56%)  1
Traumatic haemotoma  1  1/182 (0.55%)  1 0/178 (0.00%)  0
Vascular pseudoaneurysm  1  0/182 (0.00%)  0 1/178 (0.56%)  1
Investigations     
International Normalised Ratio Increased  1  1/182 (0.55%)  1 0/178 (0.00%)  0
Metabolism and nutrition disorders     
Gout  1  0/182 (0.00%)  0 1/178 (0.56%)  1
Hyperglycaemia  1  1/182 (0.55%)  1 0/178 (0.00%)  0
Hypokalaemia  1  1/182 (0.55%)  1 0/178 (0.00%)  0
Lactic acidosis  1  1/182 (0.55%)  1 0/178 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Pain in extremity  1  0/182 (0.00%)  0 1/178 (0.56%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma of colon  1  1/182 (0.55%)  1 0/178 (0.00%)  0
Basal cell carcinoma  1  0/182 (0.00%)  0 1/178 (0.56%)  1
Nervous system disorders     
Hepatic encephalopathy  1  0/182 (0.00%)  0 1/178 (0.56%)  1
Partial seizures with secondary generalisation  1  0/182 (0.00%)  0 1/178 (0.56%)  1
Psychiatric disorders     
Delerium  1  1/182 (0.55%)  1 0/178 (0.00%)  0
Psychogenic seizure  1  0/182 (0.00%)  0 1/178 (0.56%)  1
Suicidal ideation  1  0/182 (0.00%)  0 1/178 (0.56%)  1
Respiratory, thoracic and mediastinal disorders     
Respiratory failure  1  4/182 (2.20%)  4 0/178 (0.00%)  0
Bronchial haemmorhage  1  0/182 (0.00%)  0 1/178 (0.56%)  1
Chronic obstructive pulmonary disease  1  1/182 (0.55%)  1 1/178 (0.56%)  1
Pneumonia aspiration  1  1/182 (0.55%)  1 0/178 (0.00%)  0
Vascular disorders     
Aortic dissection  1  1/182 (0.55%)  1 0/178 (0.00%)  0
Distributive shock  1  1/182 (0.55%)  1 0/178 (0.00%)  0
Hypertension  1  0/182 (0.00%)  0 1/178 (0.56%)  1
Hypertensive crisis  1  1/182 (0.55%)  1 0/178 (0.00%)  0
Hypertensive emergency  1  2/182 (1.10%)  2 0/178 (0.00%)  0
Hypotension  1  1/182 (0.55%)  1 0/178 (0.00%)  0
Hypovolaemic shock  1  1/182 (0.55%)  1 0/178 (0.00%)  0
1
Term from vocabulary, MedDRA (Unspecified)
Indicates events were collected by systematic assessment
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Frequency Threshold for Reporting Other Adverse Events 0%
Spironolactone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      0/0    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
To minimize the probability of inaccurate data in published materials, it is the policy of the Heart Failure Network that all data and text considered for all papers, and all abstracts for presentation at scientific meetings be submitted to the Publication and Presentation Subcommittee, the NHLBI Project Officer, and the Coordinating Center for review and approval prior to presentation or publication.
Results Point of Contact
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Name/Title: Adrian Hernandez, MD
Organization: Duke Clinical Research Institute
Phone: 919 668 7515
EMail: adrian.hernandez@duke.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02235077    
Other Study ID Numbers: Pro00057090
5U01HL084904 ( U.S. NIH Grant/Contract )
First Submitted: September 3, 2014
First Posted: September 9, 2014
Results First Submitted: April 7, 2017
Results First Posted: May 17, 2017
Last Update Posted: June 14, 2017