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

Primary Purpose

Pulmonary Arterial Hypertension

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
E-learning
Diet
Sponsored by
Amsterdam UMC, location VUmc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension focused on measuring Nutrition, Lifestyle

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VU medical center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Control

E-learning

Diet A

Diet B

Arm Description

No intervention

E-learning: 8 lessons about nutrition and lifestyle

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

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

Outcomes

Primary Outcome Measures

Change in quality of life
To asses quality of life, the SF-36 questionnaire is used.

Secondary Outcome Measures

Change in nutritional intake
To asses dietary intake a food frequency questionnaire is used (HELIUS)
Change in vitamin and mineral status
A complete serum analyses is performed to asses vitamin and mineral status.

Full Information

First Posted
December 10, 2021
Last Updated
April 7, 2022
Sponsor
Amsterdam UMC, location VUmc
Collaborators
Reinier de Graaf Groep, Janssen-Cilag B.V.
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1. Study Identification

Unique Protocol Identification Number
NCT05318950
Brief Title
A nUtrition and Lifestyle Intervention in Patients With Pulmonary Arterial HypertensIon
Acronym
UPHILL
Official Title
A nUtrition and Lifestyle Intervention in Patients With Pulmonary Arterial HypertensIon: Effect on quaLity of Life
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 20, 2019 (Actual)
Primary Completion Date
January 20, 2021 (Actual)
Study Completion Date
February 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Amsterdam UMC, location VUmc
Collaborators
Reinier de Graaf Groep, Janssen-Cilag B.V.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
Keywords
Nutrition, Lifestyle

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Participant
Masking Description
Randomisation control and E-learning Randomisation Diet A and B
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Arm Title
E-learning
Arm Type
Experimental
Arm Description
E-learning: 8 lessons about nutrition and lifestyle
Arm Title
Diet A
Arm Type
Experimental
Arm Description
MedDASH diet (55% carbohydrates, 25% amino acids, 20% fatty acids)
Arm Title
Diet B
Arm Type
Experimental
Arm Description
MedDASHfat diet (10% carbohydrates, 25% amino acids, 65% fatty acids)
Intervention Type
Behavioral
Intervention Name(s)
E-learning
Intervention Description
8 lessons about nutrition and lifestyle
Intervention Type
Dietary Supplement
Intervention Name(s)
Diet
Intervention Description
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 Outcome Measure Information:
Title
Change in quality of life
Description
To asses quality of life, the SF-36 questionnaire is used.
Time Frame
Baseline (week 0), after nutritional education (week 10), after nutritional intervention (week 24), after follow up (week 48)
Secondary Outcome Measure Information:
Title
Change in nutritional intake
Description
To asses dietary intake a food frequency questionnaire is used (HELIUS)
Time Frame
Baseline (week 0), after nutritional education (week 10), after nutritional intervention (week 24), after follow up (week 48)
Title
Change in vitamin and mineral status
Description
A complete serum analyses is performed to asses vitamin and mineral status.
Time Frame
Baseline (week 0), after nutritional education (week 10), after nutritional intervention (week 24), after follow up (week 48)
Other Pre-specified Outcome Measures:
Title
Change in exercise capacity
Description
To determine exercise capacity subjects have to perform a six minute walking test
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)
Title
Change in heart rate variability
Description
To determine heart rate variability all patients will receive a Fitbit smartwatch.
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)
Title
Change in daily activity
Description
To determine changes in daily activity the number of steps will be assess by a Fitbit smartwatch
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anton Vonk Noordegraaf, prof. dr.
Organizational Affiliation
VUMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
VU medical center
City
Amsterdam
State/Province
Noord Holland
ZIP/Postal Code
1008MB
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

A nUtrition and Lifestyle Intervention in Patients With Pulmonary Arterial HypertensIon

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