A nUtrition and Lifestyle Intervention in Patients With Pulmonary Arterial HypertensIon

NCT05318950 | Completed DMC

• 1 other identifier: NL66484.029.18
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Arterial Hypertension

Keywords

Nutrition; Lifestyle

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in nutritional intake

  Baseline (week 0), after nutritional education (week 10), after nutritional intervention (week 24), after follow up (week 48)

• Change in vitamin and mineral status

  Baseline (week 0), after nutritional education (week 10), after nutritional intervention (week 24), after follow up (week 48)

Other Outcomes (3)

• 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)

• 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)

• 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)

Study Arms (4)

Control

NO INTERVENTION

No intervention

E-learning

EXPERIMENTAL

E-learning: 8 lessons about nutrition and lifestyle

Behavioral: E-learning

Diet A

EXPERIMENTAL

MedDASH diet (55% carbohydrates, 25% amino acids, 20% fatty acids)

Behavioral: E-learning; Dietary Supplement: Diet

Diet B

EXPERIMENTAL

MedDASHfat diet (10% carbohydrates, 25% amino acids, 65% fatty acids)

Behavioral: E-learning; Dietary Supplement: Diet

Interventions

E-learning BEHAVIORAL

8 lessons about nutrition and lifestyle

Diet A; Diet B; E-learning

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)

Diet A; Diet B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• Reinier de Graaf Groep: collaborator
• Janssen-Cilag B.V.: collaborator

Study Sites (1)

VU medical center

Amsterdam, North Holland, 1008MB, Netherlands

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

Diet

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Anton Vonk Noordegraaf, prof. dr.

  VUMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Randomisation control and E-learning Randomisation Diet A and B
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: April 8, 2022
• Study Start: October 20, 2019
• Primary Completion: January 20, 2021
• Study Completion: February 16, 2022
• Last Updated: April 8, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)