Pulmonary Arterial HypertensionUPHILLNCT05318950
A nUtrition and Lifestyle Intervention in Patients With Pulmonary Arterial HypertensIon
A study testing E-learning and Diet in people with Pulmonary Arterial Hypertension, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- E-learning and Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 Oct 2019to 16 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- E-learning, Diet
- Keywords
- Nutrition, Lifestyle
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-learningBehavioural
8 lessons about nutrition and lifestyle
DietDietary 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)
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No intervention |
| E-learning | Experimental | E-learning: 8 lessons about nutrition and lifestyle Receives: Behavioral: E-learning |
| Diet A | Experimental | MedDASH diet (55% carbohydrates, 25% amino acids, 20% fatty acids) Receives: Behavioral: E-learning; Dietary Supplement: Diet |
| Diet B | Experimental | MedDASHfat diet (10% carbohydrates, 25% amino acids, 65% fatty acids) Receives: Behavioral: E-learning; Dietary Supplement: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of life
To asses quality of life, the SF-36 questionnaire is used.
Measured: 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
To asses dietary intake a food frequency questionnaire is used (HELIUS)
Measured: 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.
Measured: Baseline (week 0), after nutritional education (week 10), after nutritional intervention (week 24), after follow up (week 48)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start20 Oct 2019
- Primary completion20 Jan 2021
- Study completion16 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- Reinier de Graaf Groep, Janssen-Cilag B.V.
- Responsible party
- Principal investigator, A. Vonk Noordegraaf, Amsterdam UMC, location VUmc
- Investigators
- Anton Vonk Noordegraaf, prof. dr., Principal investigator, VUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05318950
- Sponsor's protocol ID
- NL66484.029.18
- Acronym
- UPHILL
- Status last verified
- Apr 2022
- First submitted
- 10 Dec 2021
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A nUtrition and Lifestyle Intervention in Patients With Pulmonary Arterial HypertensIon: Effect on quaLity of Life
- ClinicalTrials.gov ID
- NCT05318950
- Acronym / sponsor ID
- UPHILL / NL66484.029.18
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- Nutrition, Lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- Reinier de Graaf Groep, Janssen-Cilag B.V.
- Study start
- 20 Oct 2019 (actual)
- Primary completion
- 20 Jan 2021 (actual)
- Study completion
- 16 Feb 2022 (actual)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No intervention |
| E-learning | Experimental | Behavioral: E-learningE-learning: 8 lessons about nutrition and lifestyle |
| Diet A | Experimental | Behavioral: E-learning, Dietary Supplement: DietMedDASH diet (55% carbohydrates, 25% amino acids, 20% fatty acids) |
| Diet B | Experimental | Behavioral: E-learning, Dietary Supplement: DietMedDASHfat diet (10% carbohydrates, 25% amino acids, 65% fatty acids) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-learning8 lessons about nutrition and lifestyle | Behavioural | Diet A, Diet B, E-learning |
| DietDiet A: MedDASH diet (55% carbohydrates, 25% amino acids, 20% fatty acids) Diet B: MedDASHfat diet (10% carbohydrates, 25% amino acids, 65% fatty acids) | Dietary supplement | Diet A, Diet B |
Primary outcome
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.
2 secondary outcomes
Change in nutritional intake
Time frame: Baseline (week 0), after nutritional education (week 10), after nutritional intervention (week 24), after follow up (week 48)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anton Vonk Noordegraaf, prof. dr. principal investigator
VUMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-learning and Diet in people with Pulmonary Arterial Hypertension, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.