Trial Outcomes & Findings for Use of Entresto Sacubitril/Valsartan for the Treatment of Peripheral Arterial Disease (NCT NCT02636283)

NCT ID: NCT02636283

Last Updated: 2019-12-17

Results Overview

Time in minutes on a standardized treadmill test to initiation of pain and time until pain requires patient to stop walking

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 6 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2019-12-17

Participant Flow

Participant milestones

Measure	Entresto oral route Entresto: Oral pills	Placebo Group Oral placebo Placebo group: The placebo pills
Overall Study STARTED	3	3
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Measure	Entresto oral route Entresto: Oral pills	Placebo Group Oral placebo Placebo group: The placebo pills
Overall Study Adverse Event	2	0
Overall Study Trial Terminated Prematurely	0	3

Baseline Characteristics

Use of Entresto Sacubitril/Valsartan for the Treatment of Peripheral Arterial Disease

Baseline characteristics by cohort

Measure	Entresto n=3 Participants oral route Entresto: Oral pills	Placebo Group n=3 Participants Oral placebo Placebo group: The placebo pills	Total n=6 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	60.7 years STANDARD_DEVIATION 4.16 • n=5 Participants	62.7 years STANDARD_DEVIATION 3.06 • n=7 Participants	61.7 years STANDARD_DEVIATION 3.45 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	00 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Study terminated prematurely; outcome measure data was not collected.

Time in minutes on a standardized treadmill test to initiation of pain and time until pain requires patient to stop walking

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: Study terminated prematurely; outcome measure data was not collected.

Post-contraction measures of mitochondrial and microvascular function using MR spectroscopy and functional MRI

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: Study terminated prematurely; outcome measure data was not collected.

Using Homeostasis Model Assessment (HOMA) index

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: Study terminated prematurely; outcome measure data was not collected.

Pulse wave pressure analysis

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: Study terminated prematurely; outcome measure data was not collected.

Questionnaires describing independent living and quality of life

Outcome measures

Outcome data not reported

Adverse Events

Entresto

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Entresto n=3 participants at risk oral route Entresto: Oral pills	Placebo Group n=3 participants at risk Oral placebo Placebo group: The placebo pills
General disorders Chest Discomfort	33.3% 1/3 • Number of events 1 • 12 weeks	0.00% 0/3 • 12 weeks
Skin and subcutaneous tissue disorders Rash	33.3% 1/3 • Number of events 1 • 12 weeks	0.00% 0/3 • 12 weeks
Cardiac disorders Hypotension	33.3% 1/3 • Number of events 1 • 12 weeks	0.00% 0/3 • 12 weeks
General disorders Pain	33.3% 1/3 • Number of events 1 • 12 weeks	0.00% 0/3 • 12 weeks

Additional Information

Otto Sanchez

University of Minnesota

Phone: 615-833-9867'

Email: sanc0050@umn.edu

Results disclosure agreements

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