Trial Condition(s):

Hypertension, Pulmonary

Electronic Activity Level Monitoring Pilot in Pulmonary Hypertension (e-MOTION PH)

Bayer Identifier:

17926

ClinicalTrials.gov Identifier:

NCT02536534

EudraCT Number:

Not Available

Study Completed

Trial Purpose

Evaluate the correlation between activity level (monitored by Fitbit Flex remote activity tracker) and 6-minute walk distance (6MWD) (performed by investigator) in patients with Pulmonary Arterial Hypertension (PAH) or Chronic Thromboembolic Pulmonary Hypertension (CTEPH) over 6 months in routine clinical practice settings.

Inclusion Criteria
- Male or female patients with a diagnosis of Pulmonary Arterial Hypertension (PAH); or inoperable, persistent or recurrent Chronic Thromboembolic Pulmonary Hypertension (CTEPH),
 - Age ≥ 18 years, 
 - Baseline 6 Minute Walk Distance (6MWD) a minimum of 250 meters or maximum 450 meters, (ensure significant Pulmonary Hypertension(PH) without limiting their participation in the trial)
 - WHO Functional Class II or III, 
 - Clinically stable patient defined as within the last 12 months (minimum of 3 months) prior to enrollment, there was no:
 -- decline in World Health Organization (WHO) Function class or, 
 -- decline in 6MWD by 15% or, 
 -- change of oral PAH/CTEPH therapy (may have flexible diuretics/anticoagulation) or, 
 -- Introduction of parenteral Prostacyclin Analog  (PCA) treatment.
 - Patients provide written informed consent, are able to understand and follow instructions.
Exclusion Criteria
- Hypersensitivity to nickel (present in the clasp of the FitBit Flex’s band),
 - Medical disorder, condition, or history of such that would impair the patient's ability to participate or complete this study in the opinion of the investigator,
 - Enrolled in pulmonary rehabilitation program within last 6 months,
 - Participating in an interventional study.

Trial Summary

Enrollment Goal
35
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Unspecified
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, Canada

Status
Completed
 

Trial Design