A nUtrition and Lifestyle Intervention in Patients With Pulmonary Arterial HypertensIon

Pulmonary Arterial Hypertension Clinical Trial

— UPHILL  

Official title:

A nUtrition and Lifestyle Intervention in Patients With Pulmonary Arterial HypertensIon: Effect on quaLity of Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05318950
• Other study ID #: NL66484.029.18
• Status: Completed
• Phase: N/A
• Start date: October 20, 2019
• Est. completion date: February 16, 2022

Study information

• Verified date: April 2022
• Source: Amsterdam UMC, location VUmc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 16, 2022
• Est. primary completion date: January 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Behavioral:
• E-learning
8 lessons about nutrition and lifestyle

Dietary Supplement:
• Diet
Diet A: MedDASH diet (55% carbohydrates, 25% amino acids, 20% fatty acids) Diet B: MedDASHfat diet (10% carbohydrates, 25% amino acids, 65% fatty acids)

Locations

Country	Name	City	State
Netherlands	VU medical center	Amsterdam	Noord Holland

Sponsors (3)

Lead Sponsor	Collaborator
Amsterdam UMC, location VUmc	Janssen-Cilag B.V., Reinier de Graaf Groep

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in exercise capacity	To determine exercise capacity subjects have to perform a six minute walking test	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)
Other	Change in heart rate variability	To determine heart rate variability all patients will receive a Fitbit smartwatch.	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)
Other	Change in daily activity	To determine changes in daily activity the number of steps will be assess by a Fitbit smartwatch	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)
Primary	Change in quality of life	To asses quality of life, the SF-36 questionnaire is used.	Baseline (week 0), after nutritional education (week 10), after nutritional intervention (week 24), after follow up (week 48)
Secondary	Change in nutritional intake	To asses dietary intake a food frequency questionnaire is used (HELIUS)	Baseline (week 0), after nutritional education (week 10), after nutritional intervention (week 24), after follow up (week 48)
Secondary	Change in vitamin and mineral status	A complete serum analyses is performed to asses vitamin and mineral status.	Baseline (week 0), after nutritional education (week 10), after nutritional intervention (week 24), after follow up (week 48)