Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2026-02-20 @ 6:07 PM
Study NCT ID:
NCT05318950
Status:
COMPLETED
Last Update Posted:
2022-04-08
First Post:
2021-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A nUtrition and Lifestyle Intervention in Patients With Pulmonary Arterial HypertensIon
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081029', 'term': 'Pulmonary Arterial Hypertension'}], 'ancestors': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004032', 'term': 'Diet'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Randomisation control and E-learning Randomisation Diet A and B'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-02-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-07', 'studyFirstSubmitDate': '2021-12-10', 'studyFirstSubmitQcDate': '2022-04-07', 'lastUpdatePostDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in exercise capacity', 'timeFrame': '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)', 'description': 'To determine exercise capacity subjects have to perform a six minute walking test'}, {'measure': 'Change in heart rate variability', 'timeFrame': '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)', 'description': 'To determine heart rate variability all patients will receive a Fitbit smartwatch.'}, {'measure': 'Change in daily activity', 'timeFrame': '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)', 'description': 'To determine changes in daily activity the number of steps will be assess by a Fitbit smartwatch'}], 'primaryOutcomes': [{'measure': 'Change in quality of life', 'timeFrame': 'Baseline (week 0), after nutritional education (week 10), after nutritional intervention (week 24), after follow up (week 48)', 'description': 'To asses quality of life, the SF-36 questionnaire is used.'}], 'secondaryOutcomes': [{'measure': 'Change in nutritional intake', 'timeFrame': 'Baseline (week 0), after nutritional education (week 10), after nutritional intervention (week 24), after follow up (week 48)', 'description': 'To asses dietary intake a food frequency questionnaire is used (HELIUS)'}, {'measure': 'Change in vitamin and mineral status', 'timeFrame': 'Baseline (week 0), after nutritional education (week 10), after nutritional intervention (week 24), after follow up (week 48)', 'description': 'A complete serum analyses is performed to asses vitamin and mineral status.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nutrition', 'Lifestyle'], 'conditions': ['Pulmonary Arterial Hypertension']}, 'descriptionModule': {'briefSummary': "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.\n\nObjective: To explore the effect of a nutrition and lifestyle intervention on quality of life for patients suffering from PAH.\n\nStudy 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.\n\nIntervention (if applicable): Nutritional status, - education, - intervention and - compliance.\n\nMain 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.\n\nNature 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.", 'detailedDescription': 'Baseline nutritional assessment\n\nNutritional education:\n\n8 online lessons containing information about nutrition, lifestyle and general health with complementary tips regarding PH. All participants recieve workbook with assignments.\n\nNutritional intervention:\n\nGroup 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.\n\nFollow-up:\n\nPatients in intervention arm followed for a period of 6 months to assess compliance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of idiopathic PAH, hereditable PAH or drug related PAH\n* Age between 18 and 80\n* NYHA II or III and stable for at least 3 months, determined by a stable 6minute walk test with a difference of \\<10%.\n* Self-sufficient and/or compliance from partner and/or family\n* Creatinine \\> 30 ml/min\n* Able to understand and willing to sign the Informed Consent Form\n\nExclusion Criteria:\n\n* \\- Pregnant subjects\n* Fat percentage \\< 10% \\> 50 %\n* One or more of the following comorbidities: diabetes mellitus type one or two, clinically relevant thyroid disease\n* Known history of noncompliance considering therapies'}, 'identificationModule': {'nctId': 'NCT05318950', 'acronym': 'UPHILL', 'briefTitle': 'A nUtrition and Lifestyle Intervention in Patients With Pulmonary Arterial HypertensIon', 'organization': {'class': 'OTHER', 'fullName': 'Amsterdam UMC, location VUmc'}, 'officialTitle': 'A nUtrition and Lifestyle Intervention in Patients With Pulmonary Arterial HypertensIon: Effect on quaLity of Life', 'orgStudyIdInfo': {'id': 'NL66484.029.18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No intervention'}, {'type': 'EXPERIMENTAL', 'label': 'E-learning', 'description': 'E-learning: 8 lessons about nutrition and lifestyle', 'interventionNames': ['Behavioral: E-learning']}, {'type': 'EXPERIMENTAL', 'label': 'Diet A', 'description': 'MedDASH diet (55% carbohydrates, 25% amino acids, 20% fatty acids)', 'interventionNames': ['Behavioral: E-learning', 'Dietary Supplement: Diet']}, {'type': 'EXPERIMENTAL', 'label': 'Diet B', 'description': 'MedDASHfat diet (10% carbohydrates, 25% amino acids, 65% fatty acids)', 'interventionNames': ['Behavioral: E-learning', 'Dietary Supplement: Diet']}], 'interventions': [{'name': 'E-learning', 'type': 'BEHAVIORAL', 'description': '8 lessons about nutrition and lifestyle', 'armGroupLabels': ['Diet A', 'Diet B', 'E-learning']}, {'name': 'Diet', 'type': 'DIETARY_SUPPLEMENT', '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)', 'armGroupLabels': ['Diet A', 'Diet B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1008MB', 'city': 'Amsterdam', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'VU medical center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'Anton Vonk Noordegraaf, prof. dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VUMC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', '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."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amsterdam UMC, location VUmc', 'class': 'OTHER'}, 'collaborators': [{'name': 'Reinier de Graaf Groep', 'class': 'OTHER'}, {'name': 'Janssen-Cilag B.V.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'A. Vonk Noordegraaf', 'investigatorAffiliation': 'Amsterdam UMC, location VUmc'}}}}