Trial Outcomes & Findings for Mineralocorticoid Receptor Antagonists (MRA) in Heart Failure (HF) and Loop Diuretic Resistance (NCT NCT02585843)

Results Overview

change in body weight measured in kilograms between weight at baseline and weight at 7 days

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

20 participants

Primary outcome timeframe

7 days

Results posted on

2019-08-08

Participant Flow

Participant milestones

Participant milestones
Measure	High-dose Spironolactone 100mg: 100mg/day of spironolactone (2 capsules), PO (oral) for 7 days Spironolactone 100mg: 2 capsules of study medication consist of 100mg, PO (oral) for 7 days	Standard of Care Spironolactone 25mg: 25mg/day of spironolactone, PO (oral) Spironolactone 25mg: 25mg/day of spironolactone
Overall Study STARTED	10	10
Overall Study COMPLETED	9	10
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mineralocorticoid Receptor Antagonists (MRA) in Heart Failure (HF) and Loop Diuretic Resistance

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High-dose n=10 Participants Spironolactone 100mg: 100mg/day of spironolactone (2 capsules), PO (oral) for 7 days Spironolactone 100mg: 2 capsules of study medication consist of 100mg, PO (oral) for 7 days	Standard of Care n=10 Participants Spironolactone 25mg: 25mg/day of spironolactone, PO (oral) Spironolactone 25mg: 25mg/day of spironolactone	Total n=20 Participants Total of all reporting groups
Age, Continuous	61.6 years STANDARD_DEVIATION 9 • n=5 Participants	63.5 years STANDARD_DEVIATION 15 • n=7 Participants	62.6 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · African American	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · White	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants
Baseline 6 minute walk test	177 meters STANDARD_DEVIATION 78 • n=5 Participants	196 meters STANDARD_DEVIATION 68 • n=7 Participants	187 meters STANDARD_DEVIATION 69 • n=5 Participants

PRIMARY outcome

Timeframe: 7 days

change in body weight measured in kilograms between weight at baseline and weight at 7 days

Outcome measures

Outcome measures
Measure	High-dose n=9 Participants Spironolactone 100mg: 100mg/day of spironolactone (2 capsules), PO (oral) for 7 days Spironolactone 100mg: 2 capsules of study medication consist of 100mg, PO (oral) for 7 days	Standard of Care n=10 Participants Spironolactone 25mg: 25mg/day of spironolactone, PO (oral) Spironolactone 25mg: 25mg/day of spironolactone
Change in Body Weight	-1.9 kilogram Standard Deviation 2.0	-1.9 kilogram Standard Deviation 1.1

SECONDARY outcome

Timeframe: 7 days

Change in estimated jugular venous pressure by physical exam in cmH2O between baseline and 7 days

Outcome measures

Outcome measures
Measure	High-dose n=9 Participants Spironolactone 100mg: 100mg/day of spironolactone (2 capsules), PO (oral) for 7 days Spironolactone 100mg: 2 capsules of study medication consist of 100mg, PO (oral) for 7 days	Standard of Care n=10 Participants Spironolactone 25mg: 25mg/day of spironolactone, PO (oral) Spironolactone 25mg: 25mg/day of spironolactone
Change in Estimated Jugular Venous Pressure (cmH2O)	-3.2 cmH2O Standard Deviation 2.5	-3.9 cmH2O Standard Deviation 2.2

SECONDARY outcome

Timeframe: 7 days

At baseline and final visit. The 6MWT will be conducted per American Thoracic Society guidelines.

Outcome measures

Outcome measures
Measure	High-dose n=9 Participants Spironolactone 100mg: 100mg/day of spironolactone (2 capsules), PO (oral) for 7 days Spironolactone 100mg: 2 capsules of study medication consist of 100mg, PO (oral) for 7 days	Standard of Care n=10 Participants Spironolactone 25mg: 25mg/day of spironolactone, PO (oral) Spironolactone 25mg: 25mg/day of spironolactone
Change in 6-minute Walk Test Distance (6MWT)	36 meters Standard Deviation 46	36 meters Standard Deviation 41

SECONDARY outcome

Timeframe: 7 days

Dyspnea will be assessed at baseline and at 7 days with the score on the visual analogue scale (VAS). The scores range from 0 (minimum) to 100 (maximum) with higher numbers representing improvements in dyspnea (i.e. better) and lower numbers representing worsening of dyspnea (i.e. worse).

Outcome measures

Outcome measures
Measure	High-dose n=9 Participants Spironolactone 100mg: 100mg/day of spironolactone (2 capsules), PO (oral) for 7 days Spironolactone 100mg: 2 capsules of study medication consist of 100mg, PO (oral) for 7 days	Standard of Care n=10 Participants Spironolactone 25mg: 25mg/day of spironolactone, PO (oral) Spironolactone 25mg: 25mg/day of spironolactone
Change in Score on the Visual Analogue Scale (VAS)	26 units on a scale Standard Deviation 34	25 units on a scale Standard Deviation 17

SECONDARY outcome

Timeframe: 7 days

Dyspnea will be assessed using a Seven-Level Likert Scale at baseline and the day 7 visit. The outcome measure will be reported as a difference between these two assessments (value at 7 days minus the value at baseline). The values on this scale range from 1 to 7 with higher numbers indicating overall better subjective assessment related to the symptom of dyspnea. Therefore, positive numbers represent an overall improvement in dyspnea during the study intervention and the higher (more positive) this difference is, the better the subject's relief of dyspnea at the conclusion of the study intervention.

Outcome measures

Outcome measures
Measure	High-dose n=9 Participants Spironolactone 100mg: 100mg/day of spironolactone (2 capsules), PO (oral) for 7 days Spironolactone 100mg: 2 capsules of study medication consist of 100mg, PO (oral) for 7 days	Standard of Care n=10 Participants Spironolactone 25mg: 25mg/day of spironolactone, PO (oral) Spironolactone 25mg: 25mg/day of spironolactone
Change From Baseline to Day 7 on the Seven-Level Likert Scale	2.1 units on a scale Standard Deviation 0.9	2.6 units on a scale Standard Deviation 0.5

Adverse Events

High-dose

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	High-dose n=10 participants at risk Spironolactone 100mg: 100mg/day of spironolactone (2 capsules), PO (oral) for 7 days Spironolactone 100mg: 2 capsules of study medication consist of 100mg, PO (oral) for 7 days	Standard of Care n=10 participants at risk Spironolactone 25mg: 25mg/day of spironolactone, PO (oral) Spironolactone 25mg: 25mg/day of spironolactone
Renal and urinary disorders Hyperkalemia	10.0% 1/10 • Number of events 1 • 12 months	0.00% 0/10 • 12 months

Additional Information

A. Reshad Garan

Columbia University

Phone: (917) 374-3346

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place