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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03146702
Other study ID # TR-034
Secondary ID
Status Completed
Phase N/A
First received May 8, 2017
Last updated February 18, 2018
Start date October 2016
Est. completion date September 2017

Study information

Verified date May 2017
Source Istanbul University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Pulmonary Hypertension (PH) is a hemodynamic and physiopathological condition that is defined as an increase in mean pulmonary artery pressure ≥25 mmHg when measured at rest. PH often progresses to heart failure and premature deaths. PH is a progressive disease that has many causes, which can affect people of all ages, is characterized by shortness of breath, reduced exercise tolerance, psychological distress and tiredness and reduced quality of life. Surveys of SF-36, 'Nottingham Health Profiles' and 'Minnesota Life with Heart Failure' surveys are routinely performed in PH clinically. However, none of the questionnaires are specific to pulmonary hypertension, so they are incomplete in determining the condition of the disease and the patients. There is no Turkish questionnaire for patients with pulmonary hypertension and other surveys used are inadequate in determining the condition of the patient and the patient since they are not specific to the disease. The aim is to provide a Turkish questionnaire that is specific to pulmonary hypertension in the literature.


Recruitment information / eligibility

Status Completed
Enrollment 101
Est. completion date September 2017
Est. primary completion date August 2017
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Have been diagnosed with Pulmonary Hypertension

- Following at least 6 months of Pulmonary Hypertension policlinic

- Native Turkish

- People age 18 years or older

Exclusion Criteria:

- Those with cognitive impairment

- Those who have difficulty understanding or speaking Turkish

Study Design


Intervention

Other:
Quality of Life
Patients self administor quality of life questionnaires such as Minnesota Living with Heart Failure Questionnaire and EmPHasis-10 questionnaire

Locations

Country Name City State
Turkey Istanbul University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Validity Validity of EmPHasis-10 Questionnaire 8 months
Primary Reliability Reliability of EmPHasis-10 Questionnaire 8 months
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