NCT02636283

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2017

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 21, 2015

Completed
2 years until next milestone

Study Start

First participant enrolled

December 31, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

December 17, 2019

Completed
Last Updated

December 17, 2019

Status Verified

December 1, 2019

Enrollment Period

10 months

First QC Date

October 29, 2015

Results QC Date

December 5, 2019

Last Update Submit

December 5, 2019

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

  • Treadmill Walk Until Pain Initiated in Minutes

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

    12 weeks

Secondary Outcomes (4)

  • Mitochondrial and Microvascular Function Arterial Elasticity

    12 weeks

  • Insulin Sensitivity

    12 weeks

  • Arterial Elasticity

    12 weeks

  • Quality of Life Questionnaires

    12 weeks

Study Arms (2)

Entresto

ACTIVE COMPARATOR

oral route

Drug: Entresto

Placebo group

PLACEBO COMPARATOR

Oral placebo

Drug: Placebo group

Interventions

EntrestoDRUG

Oral pills

Entresto
Placebo groupDRUG

The placebo pills

Placebo group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Ankle-brachial index ≤ 0.90 acquired according to the American Heart Association guidelines.
  • 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).
  • Patients on medical treatment for PAD without significant improvement in intermittent claudication within the last 6 months.

You may not qualify if:

  • Age \< 18 and \> 80 years.
  • Patients with physician diagnosed chronic kidney disease or heart failure stage II or IV or unstable angina.
  • Echocardiographic evidence of cardiomyopathies and pulmonary hypertension.
  • Patients that have received cancer treatment within the last year (except skin cancer).
  • Severe limitations in mobility due to osteomuscular disorders present at time of interview.
  • Dementia or other mental disorders that prevent patients from following a research protocol present at time of interview
  • Patients engaged in an exercise rehabilitation program within the past 6 months.
  • Patients schedule to undergo an arterial revascularization procedure during the study or have undergone one within the past 6 months.
  • Inconsistent maximal walking distance on the treadmill test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

sacubitril and valsartan sodium hydrate drug combination

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Results Point of Contact

Title
Otto Sanchez
Organization
University of Minnesota
sanc0050@umn.edu
615-833-9867'

Study Officials

  • Otto A Sanchez, M.D., Ph.D.

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2015

First Posted

December 21, 2015

Study Start

December 31, 2017

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

December 17, 2019

Results First Posted

December 17, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)