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Completed

NCT Number: NCT05318950

A nUtrition and Lifestyle Intervention in Patients With Pulmonary Arterial HypertensIon

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.

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Key information

Conditions

Pulmonary Arterial Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VU medical center

Amsterdam, North Holland, 1008MB, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

E-learning

Behavioral

8 lessons about nutrition and lifestyle

Diet

Dietary Supplement

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

Primary outcomes

  1. Change in quality of life

    Time frame: 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 outcomes

  1. Change in nutritional intake

    Time frame: 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)

  2. Change in vitamin and mineral status

    Time frame: 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 outcomes

  1. Change in exercise capacity

    Time frame: 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

  2. Change in heart rate variability

    Time frame: 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.

  3. Change in daily activity

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Collaborators

  • Janssen-Cilag B.V.
  • Reinier de Graaf Groep

Registry information

Official study title

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

Acronym: UPHILL

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Apr 8, 2022
Registry last updated
Apr 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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