Status:
COMPLETED
A nUtrition and Lifestyle Intervention in Patients With Pulmonary Arterial HypertensIon
Lead Sponsor:
Amsterdam UMC, location VUmc
Collaborating Sponsors:
Reinier de Graaf Groep
Janssen-Cilag B.V.
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Rationale: Nutrition and lifestyle interventions are currently not implemented in usual clinical care of PAH-patients. Mainly because there is little known on the relation between pathology, nutrition...
Detailed Description
Baseline nutritional assessment Nutritional education: 8 online lessons containing information about nutrition, lifestyle and general health with complementary tips regarding PH. All participants re...
Eligibility Criteria
Inclusion
- Diagnosis of idiopathic PAH, hereditable PAH or drug related PAH
- Age between 18 and 80
- NYHA II or III and stable for at least 3 months, determined by a stable 6minute walk test with a difference of \<10%.
- Self-sufficient and/or compliance from partner and/or family
- Creatinine \> 30 ml/min
- Able to understand and willing to sign the Informed Consent Form
Exclusion
- \- Pregnant subjects
- Fat percentage \< 10% \> 50 %
- One or more of the following comorbidities: diabetes mellitus type one or two, clinically relevant thyroid disease
- Known history of noncompliance considering therapies
Key Trial Info
Start Date :
October 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 16 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05318950
Start Date
October 20 2019
End Date
February 16 2022
Last Update
April 8 2022
Active Locations (1)
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1
VU medical center
Amsterdam, North Holland, Netherlands, 1008MB