Pulmonary Arterial Hypertension
Conditions
Keywords
Nutrition, Lifestyle
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 and lifestyle. Patients who suffer from Pulmonary Arterial Hypertension feel insecure about their nutrition and lifestyle. The investigators hypothesize that an intervention on nutrition and lifestyle can improve the patients' quality of life. Objective: To explore the effect of a nutrition and lifestyle intervention on quality of life for patients suffering from PAH. Study design: Investigator initiated intervention study with control group. Study population: investigators aim to include 70 patients (18 - 80 years) with idiopathic, hereditable or drug related PAH, who have been stable for at least three months and are self-sufficient and/or have a family who's willing to participate in the lifestyle changes. Intervention (if applicable): Nutritional status, - education, - intervention and - compliance. Main study parameters/endpoints: This is an intervention study in which the investigators will asses the effect of a nutrition and lifestyle intervention on quality of life measured by SF-36 overall outcome with a significant difference of 6.35. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden for the patient exists of 12 extra visits to the hospital and contact moments, over a period of 11 months, as well compliance to the diet and lifestyle. There is minimal risk in participation.
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 recieve workbook with assignments. Nutritional intervention: Group A: MedDASH diet (55% carbohydrates, 25% amino acids, 20% fatty acids) Group B: MedDASHfat diet (10% carbohydrates, 25% amino acids, 65% fatty acids) Control group: no diet. Follow-up: Patients in intervention arm followed for a period of 6 months to assess compliance.
Interventions
BEHAVIORALE-learning
8 lessons about nutrition and lifestyle
DIETARY_SUPPLEMENTDiet
Diet A: MedDASH diet (55% carbohydrates, 25% amino acids, 20% fatty acids) Diet B: MedDASHfat diet (10% carbohydrates, 25% amino acids, 65% fatty acids)
Sponsors
Reinier de Graaf Groep
Janssen-Cilag B.V.
Amsterdam UMC, location VUmc
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Randomisation control and E-learning Randomisation Diet A and B
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* \- 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in quality of life | Baseline (week 0), after nutritional education (week 10), after nutritional intervention (week 24), after follow up (week 48) | To asses quality of life, the SF-36 questionnaire is used. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in nutritional intake | Baseline (week 0), after nutritional education (week 10), after nutritional intervention (week 24), after follow up (week 48) | To asses dietary intake a food frequency questionnaire is used (HELIUS) |
| Change in vitamin and mineral status | Baseline (week 0), after nutritional education (week 10), after nutritional intervention (week 24), after follow up (week 48) | A complete serum analyses is performed to asses vitamin and mineral status. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in exercise capacity | Baseline (week 0), after nutritional intervention (week 24), after follow up (week 48). The Fitbit is worn by intervention group over total study time (48 weeks) | To determine exercise capacity subjects have to perform a six minute walking test |
| Change in heart rate variability | Baseline (week 0), after nutritional intervention (week 24), after follow up (week 48). The Fitbit is worn by intervention group over total study time (48 weeks) | To determine heart rate variability all patients will receive a Fitbit smartwatch. |
| Change in daily activity | Baseline (week 0), after nutritional intervention (week 24), after follow up (week 48). The Fitbit is worn by intervention group over total study time (48 weeks) | To determine changes in daily activity the number of steps will be assess by a Fitbit smartwatch |
Countries
Netherlands
Outcome results
None listed