Trial Outcomes & Findings for PIE II: Pharmacological Intervention in the Elderly II (NCT NCT00123955)

Results Overview

Peak exercise VO2

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

80 participants

Primary outcome timeframe

Baseline, 4 and 9 months

Results posted on

2019-02-27

Participant Flow

Participant milestones

Participant milestones
Measure	Spironolactone Spironolactone Spironolactone: 25mg tablet daily for 9 months	Placebo Placebo Placebo: Placebo tablet daily for 9 months
Overall Study STARTED	42	38
Overall Study COMPLETED	37	34
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Spironolactone Spironolactone Spironolactone: 25mg tablet daily for 9 months	Placebo Placebo Placebo: Placebo tablet daily for 9 months
Overall Study Adverse Event	1	0
Overall Study Withdrawal by Subject	4	3
Overall Study Death	0	1

Baseline Characteristics

PIE II: Pharmacological Intervention in the Elderly II

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Spironolactone n=42 Participants Spironolactone Spironolactone: 25mg tablet daily for 9 months	Placebo n=38 Participants Placebo Placebo: Placebo tablet daily for 9 months	Total n=80 Participants Total of all reporting groups
Age, Continuous	70.0 years STANDARD_DEVIATION 7.3 • n=99 Participants	71.7 years STANDARD_DEVIATION 7.3 • n=107 Participants	70.8 years STANDARD_DEVIATION 7.3 • n=206 Participants
Sex: Female, Male Female	34 Participants n=99 Participants	30 Participants n=107 Participants	64 Participants n=206 Participants
Sex: Female, Male Male	8 Participants n=99 Participants	8 Participants n=107 Participants	16 Participants n=206 Participants
Peak VO2 (ml/kg/min)	13.5 ml/kg/min STANDARD_DEVIATION 2.9 • n=99 Participants	13.3 ml/kg/min STANDARD_DEVIATION 2.9 • n=107 Participants	13.4 ml/kg/min STANDARD_DEVIATION 2.9 • n=206 Participants
Workload (Watts)	63 Watts STANDARD_DEVIATION 26 • n=99 Participants	60 Watts STANDARD_DEVIATION 26 • n=107 Participants	62 Watts STANDARD_DEVIATION 26 • n=206 Participants

PRIMARY outcome

Timeframe: Baseline, 4 and 9 months

Population: The outcome measure data uses data from all participants with 4 and/or 9 month follow-up. Thirty-seven participants randomized to spironolactone and 35 participants randomized to placebo completed 4 months of follow-up, and 37 participants randomized to spironolactone and 34 participants randomized to placebo completed 9 months of follow-up.

Peak exercise VO2

Outcome measures

Outcome measures
Measure	Spironolactone n=37 Participants Spironolactone Spironolactone: 25mg tablet daily for 9 months	Placebo n=35 Participants Placebo Placebo: Placebo tablet daily for 9 months
Exercise Intolerance 9 months	13.8 ml/kg/min Standard Deviation 3.2	13.9 ml/kg/min Standard Deviation 3.7
Exercise Intolerance Baseline	13.5 ml/kg/min Standard Deviation 2.9	13.3 ml/kg/min Standard Deviation 2.9
Exercise Intolerance 4 months	13.6 ml/kg/min Standard Deviation 3.5	13.5 ml/kg/min Standard Deviation 3.4

PRIMARY outcome

Timeframe: Baseline, 4 and 9 months

The Minnesota Living with Heart Failure Questionnaire (MLHF) is a self-administered disease-specific questionnaire for patients with Heart Failure, comprising 21 items rated on six-point Likert scales, representing different degrees of impact of HF on HRQoL, from 0 (none) to 5 (very much). It provides a total score (range 0-105, from best to worst HRQoL), as well as scores for two dimensions, physical (8 items, range 0-40) and emotional (5 items, range 0-25). The other eight items (of the total of 21) are only considered for the calculation of the total score. Scale of 0-105:The higher the score the worse the heart failure related Quality of Life.

Outcome measures

Outcome measures
Measure	Spironolactone n=37 Participants Spironolactone Spironolactone: 25mg tablet daily for 9 months	Placebo n=35 Participants Placebo Placebo: Placebo tablet daily for 9 months
Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire-total Score Baseline	32 units on a scale Standard Deviation 21	28 units on a scale Standard Deviation 19
Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire-total Score 4 months	29 units on a scale Standard Deviation 20	29 units on a scale Standard Deviation 23
Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire-total Score Final- 9 months	29 units on a scale Standard Deviation 18	25 units on a scale Standard Deviation 18

SECONDARY outcome

Timeframe: Baseline, 9 month

Left ventricle measurements by MRI: Mass/end diastolic volume ratio: g/ml

Outcome measures

Outcome measures
Measure	Spironolactone n=37 Participants Spironolactone Spironolactone: 25mg tablet daily for 9 months	Placebo n=35 Participants Placebo Placebo: Placebo tablet daily for 9 months
Concentric Left Ventricular Remodeling baseline	1.8 g/ml Standard Deviation .4	1.7 g/ml Standard Deviation .5
Concentric Left Ventricular Remodeling 9 month	1.7 g/ml Standard Deviation .4	1.6 g/ml Standard Deviation .4

SECONDARY outcome

Timeframe: Baseline, 4 month and 9 month

Echocardiography Doppler measurement of left ventricular diastolic function: Early mitral annulus velocity (lateral) (Ea; cm/s)

Outcome measures

Outcome measures
Measure	Spironolactone n=37 Participants Spironolactone Spironolactone: 25mg tablet daily for 9 months	Placebo n=35 Participants Placebo Placebo: Placebo tablet daily for 9 months
Left Ventricular Diastolic Stiffness 9 month	7.4 cm/s Standard Deviation 2.2	6.6 cm/s Standard Deviation 1.6
Left Ventricular Diastolic Stiffness baseline	7.0 cm/s Standard Deviation 2.1	6.8 cm/s Standard Deviation 1.4
Left Ventricular Diastolic Stiffness 4 month	7.0 cm/s Standard Deviation 2.1	6.8 cm/s Standard Deviation 1.4

Adverse Events

Spironolactone

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Spironolactone n=42 participants at risk Spironolactone Spironolactone: 25mg tablet daily for 9 months	Placebo n=38 participants at risk Placebo Placebo: Placebo tablet daily for 9 months
Cardiac disorders Hospitalization for chest pain	4.8% 2/42 • Number of events 2	2.6% 1/38 • Number of events 1
General disorders Elective surgery	2.4% 1/42 • Number of events 1	7.9% 3/38 • Number of events 3
Cardiac disorders Hospitalization for shortness of breath	0.00% 0/42	7.9% 3/38 • Number of events 5
Cardiac disorders Hospitalization for syncope	4.8% 2/42 • Number of events 2	0.00% 0/38
Cardiac disorders Hospitalization for hypotension	2.4% 1/42 • Number of events 1	0.00% 0/38
Vascular disorders Hospitalization for angioedema	2.4% 1/42 • Number of events 1	0.00% 0/38
General disorders Death	0.00% 0/42	2.6% 1/38 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Dr. Dalane Kitzman

Wake Forest Baptist Health

Phone: 336-716-3274

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place