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

• Status: Terminated
• Trial end date: 2018-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study proposes the use of Entresto (sacubitril/valsartan) to test the effects on pain free walking duration on patients with peripheral arterial disease, a condition caused by decreased blood flow to the muscles in the legs.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Collaborator: American Heart Association
• Treatments: LCZ 696; Sacubitril and valsartan sodium hydrate drug combination; Valsartan

Criteria

Inclusion Criteria:

1. Subject with symptoms of intermittent claudication, such as exercise-induced pain, cramps, fatigue, or other equivalent discomfort, involving large muscle groups of the leg(s) (calf, thigh, buttocks), relieved by rest.

2. Ankle-brachial index ≤ 0.90 acquired according to the American Heart Association guidelines.

3. Highest ankle pressure reduced by at least 25 mm Hg after exercise compared to resting pressure (or loss of previously present Doppler signal for both the posterior tibial and anterior tibial arteries immediately after exercise if arteries were incompressible).

4. Patients on medical treatment for PAD without significant improvement in intermittent claudication within the last 6 months.

Exclusion Criteria:

1. Age < 18 and > 80 years.

2. Patients with physician diagnosed chronic kidney disease or heart failure stage II or IV or unstable angina.

3. Echocardiographic evidence of cardiomyopathies and pulmonary hypertension.

4. Patients that have received cancer treatment within the last year (except skin cancer).

5. Severe limitations in mobility due to osteomuscular disorders present at time of interview.

6. Dementia or other mental disorders that prevent patients from following a research protocol present at time of interview

7. Patients engaged in an exercise rehabilitation program within the past 6 months.

8. Patients schedule to undergo an arterial revascularization procedure during the study or have undergone one within the past 6 months.

9. Inconsistent maximal walking distance on the treadmill test.