Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-25 @ 9:44 PM
Study NCT ID:
NCT01288651
Status:
UNKNOWN
Last Update Posted:
2011-02-02
First Post:
2011-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Iron Deficiency In Pulmonary Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065627', 'term': 'Familial Primary Pulmonary Hypertension'}, {'id': 'D000081029', 'term': 'Pulmonary Arterial Hypertension'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-02-01', 'studyFirstSubmitDate': '2011-02-01', 'studyFirstSubmitQcDate': '2011-02-01', 'lastUpdatePostDateStruct': {'date': '2011-02-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'six-minute walking distance', 'timeFrame': '12 weeks', 'description': 'The primary endpoint is improvement in six-minute walking distance'}], 'secondaryOutcomes': [{'measure': 'Serum iron parameters', 'timeFrame': '0 and 12 weeks', 'description': 'Serum iron parameters and inflammatory parameters are measured'}, {'measure': 'Exercise capacity', 'timeFrame': '0 and 12 weeks', 'description': 'Cardiopulmonary exercise testing is performed to measure maximal exercise capacity and exercise endurance time.'}, {'measure': 'Quadriceps muscle function', 'timeFrame': '0 and 12 weeks', 'description': 'A biopsy from the quadriceps muscle is taken for histochemical analysis, myoglobin measurements and muscle fiber strength characteristics'}, {'measure': 'Cardiac Function', 'timeFrame': '0 and 12 weeks', 'description': 'A cardiac MRI is performed to measure cardiac function'}, {'measure': 'Quality of life', 'timeFrame': '0 and 12 weeks', 'description': 'Quality of life and NYHA functional class is established.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pulmonary arterial hypertension', 'Iron deficiency', 'Exercise'], 'conditions': ['Idiopathic Pulmonary Arterial Hypertension']}, 'referencesModule': {'references': [{'pmid': '26401247', 'type': 'DERIVED', 'citation': 'Ruiter G, Manders E, Happe CM, Schalij I, Groepenhoff H, Howard LS, Wilkins MR, Bogaard HJ, Westerhof N, van der Laarse WJ, de Man FS, Vonk-Noordegraaf A. Intravenous iron therapy in patients with idiopathic pulmonary arterial hypertension and iron deficiency. Pulm Circ. 2015 Sep;5(3):466-72. doi: 10.1086/682217.'}]}, 'descriptionModule': {'briefSummary': 'Patients with idiopathic pulmonary arterial hypertension (IPAH) and iron deficiency were previously shown to have a decreased six-minute walking distance. Therefore the investigators hypothesized that intravenous iron administration would improve exercise capacity in iron deficient IPAH patients.\n\n30 patients will be recruited for iron infusions. At baseline and after 12 weeks (endpoint)exercise test will be performed.', 'detailedDescription': 'Background: Patients with pulmonary arterial hypertension (PAH) develop progressive right heart failure which eventually will lead to death. During progression of the disease the physical performance of the patients deteriorates. Maintaining their exercise capacity is a major goal in PAH treatment. Iron treatment is known to have a positive effect on physical performance in patients with left heart failure and iron deficiency. Whether this is also effective in patients with right heart failure (PAH) and iron deficiency is until now unknown.\n\nObjective: To evaluate the effects of intravenous iron supplementation on exercise capacity in iron deficient IPAH patients.\n\nStudy design: Intervention study\n\nStudy population: Patients with idiopathic pulmonary arterial hypertension (IPAH) and iron deficiency\n\nPatients receive an iron bolus infusion of 1000 mg iron after baseline measurements.\n\nMain study parameters/endpoints:\n\nPrimary endpoint: six minute walking distance (6WMD) Secondary endpoints: cardiopulmonary exercise test, myoglobin concentration in quadriceps muscle, quadriceps muscle fiber strength, serum iron parameters, serum inflammatory parameters, quality of life (QOL), and NYHA functional class.\n\nThe patients will be hospitalised two days at the beginning and two days at the end of the study to perform the exercise and strength tests, six minute walking distance and for biopsy of the quadriceps muscle. Also NYHA functional class will be determined and a QOL questionnaire has to be filled in. After the baseline measurements an iron infusion will be given (Ferinject 1000mg).\n\nThe investigators hypothesize that iron deficient IPAH patients will benefit from iron treatment with improved exercise capacity reflected in an increased 6MWD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stable idiopathic pulmonary arterial hypertension (stable disease for at least 3 months)\n* iron deficiency (serum iron below 10 μmol/l, decreased transferrin saturation (\\< 15% in females and \\< 20% in males) and serum ferritin \\< 100 μg/l) irrespective of the coexistence of anaemia\n\nExclusion Criteria:\n\n* Current iron therapy (oral or iv)\n* Current other study medication for PAH\n* History of anaemia or current treatment for anaemia\n* Liver function impairment\n* Chronic disease other than PAH (rheumatism, asthma, chronic infection)\n* Acute infection'}, 'identificationModule': {'nctId': 'NCT01288651', 'briefTitle': 'Iron Deficiency In Pulmonary Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'Amsterdam UMC, location VUmc'}, 'officialTitle': 'Intravenous Iron Treatment In Iron Deficient Patients With Idiopathic Pulmonary Arterial Hypertension', 'orgStudyIdInfo': {'id': '2010-247'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ferricarboxymaltose', 'type': 'DRUG', 'description': 'Ferricarboxymaltose (Ferinject®, Vifor Pharma) is used for intravenous iron administration. This iron is administered in high dose iron infusion of 1000 mg iron (equals 20 ml Ferinject) in 250 ml saline in the vein (infusion site)within 2 hours. During infusion, patients will be observed and blood pressure and heart rate are monitored before and after administration.\n\nFour weeks after iron administration, iron parameters are measured in the general practitioners setting. When iron parameters are still under normal values, a repeat infusion will be given of 500 mg iron (equals 10 ml Ferinject).'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amsterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Gerrina Ruiter, MD', 'role': 'CONTACT', 'email': 'G.Ruiter@vumc.nl', 'phone': '+31 20 444 4915'}, {'name': 'Anton Vonk Noordegraaf, Prof MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'VUmc', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'centralContacts': [{'name': 'Gerrina Ruiter, MD', 'role': 'CONTACT', 'email': 'G.Ruiter@vumc.nl', 'phone': '+31 20 444 4915'}, {'name': 'Anton Vonk-Noordegraaf, Prof MD PhD', 'role': 'CONTACT', 'email': 'A.Vonk@vumc.nl', 'phone': '+31 20 444 4710'}], 'overallOfficials': [{'name': 'Anton Vonk-Noordegraaf, Prof MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VU University Medical Center, Deparment of Pulmonology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amsterdam UMC, location VUmc', 'class': 'OTHER'}, 'collaborators': [{'name': 'Vifor Pharma', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'G. Ruiter, MD', 'oldOrganization': 'VU university medical center, Department of Pulmonology'}}}}