A nUtrition and Lifestyle Intervention in Patients With Pulmonary Arterial HypertensIon (UPHILL)

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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Arterial Hypertension
• Intervention / Treatment: Behavioral: E-learning; Dietary supplement: Diet

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Noord Holland
    • Amsterdam, Noord Holland, Netherlands, 1008MB
      • VU Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; No intervention
Experimental: E-learning; E-learning: 8 lessons about nutrition and lifestyle	Behavioral: E-learning; 8 lessons about nutrition and lifestyle
Experimental: Diet A; MedDASH diet (55% carbohydrates, 25% amino acids, 20% fatty acids)	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)
Experimental: Diet B; MedDASHfat diet (10% carbohydrates, 25% amino acids, 65% fatty acids)	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)

Collaborators and Investigators

• Sponsor: Amsterdam UMC, location VUmc
• Collaborators: Reinier de Graaf Groep; Janssen-Cilag B.V.
• Investigators: Principal Investigator: Anton Vonk Noordegraaf, prof. dr., VUMC

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2019
• Primary Completion (Actual): January 20, 2021
• Study Completion (Actual): February 16, 2022

Study Registration Dates

• First Submitted: December 10, 2021
• First Submitted That Met QC Criteria: April 7, 2022
• First Posted (Actual): April 8, 2022

Study Record Updates

• Last Update Posted (Actual): April 8, 2022
• Last Update Submitted That Met QC Criteria: April 7, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Nutrition; Lifestyle
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension, Pulmonary; Hypertension; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension
• Other Study ID Numbers: NL66484.029.18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data of the study will be kept by the principal investigators and will be available for regulatory authorities. Subjects' personal data will be stored confidentially according to institutional routine. In principle, results will be published in peer-reviewed international journals.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No