Trial Outcomes & Findings for Effects of Aliskiren on Patient With Heart Failure and a Normal Ejection Fraction (NCT NCT00982033)

NCT ID: NCT00982033

Last Updated: 2019-02-27

Results Overview

Treadmill exercise time to exhaustion on the modified naughton protocol. LS-mean is in effect, within-group means appropriately adjusted for the other effects in the model.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 52 participants
• Primary outcome timeframe: Baseline, 24 week visit
• Results posted on: 2019-02-27

Participant Flow

Participant milestones

Measure	Aliskiren 50 % of subjects participating in this trial will be on the active medication, Aliskiren 300mg qd, the other 50% will be on placebo. aliskiren: aliskiren 300mg qd versus placebo for 24 weeks.	Placebo 50% of subjects will be randomized to placebo. placebo: placebo qd for 24 weeks
Overall Study STARTED	25	27
Overall Study COMPLETED	25	27
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Aliskiren on Patient With Heart Failure and a Normal Ejection Fraction

Baseline characteristics by cohort

Measure	Aliskiren n=25 Participants 50 % of subjects participating in this trial will be on the active medication, Aliskiren 300mg qd. aliskiren: aliskiren 300mg qd for 24 weeks.	Placebo n=27 Participants 50% of subjects participating in this trial will be randomized to placebo. placebo: placebo qd for 24 weeks.	Total n=52 Participants Total of all reporting groups
Age, Continuous	69.3 years STANDARD_DEVIATION 6.3 • n=5 Participants	70.6 years STANDARD_DEVIATION 7.7 • n=7 Participants	69.9 years STANDARD_DEVIATION 7.04 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	23 Participants n=7 Participants	42 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 24 week visit

Treadmill exercise time to exhaustion on the modified naughton protocol.

LS-mean is in effect, within-group means appropriately adjusted for the other effects in the model.

Outcome measures

Measure	Aliskiren n=25 Participants 50 % of subjects participating in this trial will be on the active medication, Aliskiren 300mg qd. aliskiren: aliskiren 300mg qd for 24 weeks.	Placebo n=27 Participants 50% of subjects participating in this trial will be randomized to placebo. placebo: placebo qd for 24 weeks.
Exercise Treadmill Time Baseline	621 seconds Standard Deviation 120	580 seconds Standard Deviation 126
Exercise Treadmill Time 24 Week	624 seconds Standard Deviation 151	579 seconds Standard Deviation 145
Exercise Treadmill Time LS Mean	607 seconds Standard Deviation 13	605 seconds Standard Deviation 12

Adverse Events

Aliskiren

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo

Serious events: 4 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Measure	Aliskiren n=25 participants at risk 50 % of subjects participating in this trial will be on the active medication, Aliskiren 300mg qd. aliskiren: aliskiren 300mg qd for 24 weeks.	Placebo n=27 participants at risk 50% of subjects participating in this trial will be randomized to placebo. placebo: placebo qd for 24 weeks.
Cardiac disorders dyspnea, CHF exacerbation	0.00% 0/25 • 2 years, 2 months	7.4% 2/27 • Number of events 2 • 2 years, 2 months
Gastrointestinal disorders small bowel obstruction	0.00% 0/25 • 2 years, 2 months	7.4% 2/27 • Number of events 2 • 2 years, 2 months

Other adverse events

Measure	Aliskiren n=25 participants at risk 50 % of subjects participating in this trial will be on the active medication, Aliskiren 300mg qd. aliskiren: aliskiren 300mg qd for 24 weeks.	Placebo n=27 participants at risk 50% of subjects participating in this trial will be randomized to placebo. placebo: placebo qd for 24 weeks.
Musculoskeletal and connective tissue disorders leg, back and or joint pain	8.0% 2/25 • Number of events 2 • 2 years, 2 months	7.4% 2/27 • Number of events 2 • 2 years, 2 months
Nervous system disorders altered mental status	0.00% 0/25 • 2 years, 2 months	7.4% 2/27 • Number of events 2 • 2 years, 2 months
Surgical and medical procedures root canal	0.00% 0/25 • 2 years, 2 months	3.7% 1/27 • Number of events 1 • 2 years, 2 months
Cardiac disorders increased blood pressure	0.00% 0/25 • 2 years, 2 months	3.7% 1/27 • Number of events 1 • 2 years, 2 months
Respiratory, thoracic and mediastinal disorders pneumonia and or upper respiratory infection	0.00% 0/25 • 2 years, 2 months	7.4% 2/27 • Number of events 2 • 2 years, 2 months
Gastrointestinal disorders abdominal pain, colitis, and or virus	4.0% 1/25 • Number of events 1 • 2 years, 2 months	7.4% 2/27 • Number of events 2 • 2 years, 2 months
Ear and labyrinth disorders ear and or eye infection	4.0% 1/25 • Number of events 1 • 2 years, 2 months	3.7% 1/27 • Number of events 1 • 2 years, 2 months
Endocrine disorders viral symdrom and or possible thrush	4.0% 1/25 • Number of events 1 • 2 years, 2 months	0.00% 0/27 • 2 years, 2 months
Cardiac disorders atrial fibrillation and or palpitations	4.0% 1/25 • Number of events 1 • 2 years, 2 months	3.7% 1/27 • Number of events 1 • 2 years, 2 months
Nervous system disorders numbness in left arm	0.00% 0/25 • 2 years, 2 months	3.7% 1/27 • Number of events 1 • 2 years, 2 months

Additional Information

Dalane W. Kitzman, M.D.

Wake Forest School of Medicine

Phone: 336-716-3274

Email: dkitzman@wakehealth.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60