Ignite Creation Date:
2025-12-26 @ 5:24 PM
Ignite Modification Date:
2026-03-25 @ 9:47 PM
Study NCT ID:
NCT06785506
Status:
RECRUITING
Last Update Posted:
2025-01-21
First Post:
2024-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multiple-biomarker Approach for Individualized Treatment of Heart Failure with Preserved Ejection Fraction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054144', 'term': 'Heart Failure, Diastolic'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood (EDTA plasma, citrate plasma, serum) and urine samples are taken at the day of inclusion and at follow-up visits, which will be performed every 6 months, until the end of the scheduled follow-up, or until the patient dies. The maximum total number of samples per patient is 8 (in patients with 3.5 year follow-up).'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-20', 'studyFirstSubmitDate': '2024-07-15', 'studyFirstSubmitQcDate': '2025-01-20', 'lastUpdatePostDateStruct': {'date': '2025-01-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary endpoint is the number of participants with a combined endpoint of: urgent visit resulting in intravenous therapy for HF, hospital readmission for acute or worsened HF, and cardiovascular death.', 'timeFrame': 'Every 6 months, up to 3,5 years', 'description': 'This is a composite endpoint; therefore, the first occurrence of any of the described components will result in the endpoint being met for an individual patient.'}], 'secondaryOutcomes': [{'measure': 'Number of participants with urgent visit resulting in intravenous therapy for heart failure', 'timeFrame': 'Every 6 months, up to 3,5 years'}, {'measure': 'Number of patients with hospital readmission for acute or worsened HF', 'timeFrame': 'Every 6 months, up to 3.5 years'}, {'measure': 'Number of participants with cardiovascular death.', 'timeFrame': 'Every 6 months, up to 3.5 years'}, {'measure': 'Number of participants with the combined endpoint urgent visit resulting in intravenous therapy for HF, hospital readmission for acute or worsened HF, and all-cause death.', 'timeFrame': 'Every 6 months, up to 3,5 years', 'description': 'This is a composite endpoint; therefore, the first occurrence of any of the described components will result in the endpoint being met for an individual patient.'}, {'measure': 'Number of partcipants with all-cause death', 'timeFrame': 'Every 6 months, up to 3,5 years'}, {'measure': 'Number of participants with the combined endpoint of myocardial infarction (fatal and non-fatal), stroke (fatal and non-fatal), percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG)', 'timeFrame': 'Every 6 months, up to 3,5 years', 'description': 'This is a composite endpoint; therefore, the first occurrence of any of the described components will result in the endpoint being met for an individual patient.'}, {'measure': 'Number of participants with cardiovascular disease (includes all of the above-mentioned components, except all-cause death)', 'timeFrame': 'Every 6 months, up to 3,5 years', 'description': 'This is a composite endpoint; therefore, the first occurrence of any of the described components will result in the endpoint being met for an individual patient.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HFpEF', 'Heart failure', 'preserved ejection fraction', 'biomarkers'], 'conditions': ['Heart Failure with Preserved Ejection Fraction', 'Heart Failure, Diastolic', 'Chronic Heart Failure']}, 'descriptionModule': {'briefSummary': 'The primary objective is to investigate the association between temporal evolutions of blood biomarkers and clinical adverse events, in order to produce a dynamic, individual, and accurate prediction model for patients with HFpEF.\n\nMoreover several secondary objectives will be investigated.', 'detailedDescription': 'This is a prospective, observational multi-center cohort study which will be conducted at the cardiology departments of the Erasmus Medical Centre (EMC) as well as five other hospitals. A total of 200 HFpEF patients will be included in the study via the outpatient clinics. The follow-up period will constitute a minimum of 2 years and a maximum of 3.5 years. Clinical data will be collected at baseline and blood samples will be collected at baseline and subsequently every 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a (suspected) diagnosis of HFpEF will be recruited through the Cardiology outpatient clinics of the Erasmus MC and five other hospitals.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age of 18 years or older\n* Capable of understanding and signing informed consent\n* A diagnosis of HFpEF according to the HFA-PEFF diagnostic algorithm of the ESC or/and a high (90%) probability of HFpEF according to the H2FPEF score, i.e. a score of 6 or higher.\n\nExclusion Criteria:\n\n* History of LVEF ≤40%\n* Scheduled for surgery or intervention for both coronary and non-coronary indication within 6 months of inclusion\n* Impaired renal function, defined as eGFR \\< 20 mL/min/1.73 m2 (CKD-EPI) or requiring dialysis at the time of screening\n* Acute or chronic liver disease, defined by serum levels of transaminases or alkaline phosphatase more than three times the upper limit of normal at screening\n* COPD Gold stage IV\n* Congenital heart disease\n* Pregnancy\n* Coexistent condition with life expectancy of \\<1 year\n* Unlikely to appear at all scheduled follow-up visits\n* Linguistic barrier'}, 'identificationModule': {'nctId': 'NCT06785506', 'acronym': 'ADAPT-HFpEF', 'briefTitle': 'Multiple-biomarker Approach for Individualized Treatment of Heart Failure with Preserved Ejection Fraction', 'organization': {'class': 'OTHER', 'fullName': 'Erasmus Medical Center'}, 'officialTitle': 'A Dynamic, Multiple-biomarker Approach Aiming for Individualized Treatment of Heart Failure with Preserved Ejection Fraction (ADAPT-HFpEF)', 'orgStudyIdInfo': {'id': 'MEC-2022-0408'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Heart failure patients visiting the outpatient clinic', 'description': 'Heart failure patients visiting the outpatient clinic'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1815JD', 'city': 'Alkmaar', 'state': 'North Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Sanneke de Boer, Dr', 'role': 'CONTACT', 'email': 'spm.de.boer@nwz.nl'}, {'name': 'Mylene Loncq de Jong, MD', 'role': 'CONTACT', 'email': 'm.loncqdejong@nwz.nl'}], 'facility': 'Noordwest Ziekenhuisgroep', 'geoPoint': {'lat': 52.63167, 'lon': 4.74861}}, {'zip': '1081HV', 'city': 'Amsterdam', 'state': 'North Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Louis L Handoko, Dr.', 'role': 'CONTACT', 'email': 'ml.handoko@amsterdamumc.nl'}, {'name': 'Mylene M Loncq de Jong, MD', 'role': 'CONTACT', 'email': 'm.loncqdejong@amsterdamumc.nl'}], 'facility': 'Amsterdam UMC', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '1091AC', 'city': 'Amsterdam', 'state': 'North Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Loek L van Heerebeek, Dr.', 'role': 'CONTACT', 'email': 'l.vanheerebeek@olvg.nl'}, {'name': 'Mylene Loncq de Jong, MD', 'role': 'CONTACT'}], 'facility': 'OLVG Ziekenhuis', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '3004BA', 'city': 'Rotterdam', 'state': 'South Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Bas van Dalen, Dr.', 'role': 'CONTACT', 'email': 'b.vandalen@franciscus.nl'}, {'name': 'Suzie Tiebout, BSc', 'role': 'CONTACT', 'email': 's.tiebout@franciscus.nl'}], 'facility': 'Franciscus Gasthuis & Vlietland Ziekenhuis', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '3015GD', 'city': 'Rotterdam', 'state': 'South Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Isabella Kardys, Professor', 'role': 'CONTACT', 'email': 'i.kardys@erasmusmc.nl', 'phone': '+31650032051'}, {'name': 'Jasper Brugts, Professor', 'role': 'CONTACT', 'email': 'j.brugts@erasmusmc.nl'}], 'facility': 'Erasmus MC', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '3083AN', 'city': 'Rotterdam', 'state': 'South Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Mireille Emans, Dr.', 'role': 'CONTACT', 'email': 'memans@cardiologieopzuid.nl'}, {'name': 'Jose De Mira, MD', 'role': 'CONTACT', 'email': 'j.m.de.mira@ikazia.nl'}], 'facility': 'Ikazia Ziekenhuis', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'centralContacts': [{'name': 'Isabella Kardys, Prof.', 'role': 'CONTACT', 'email': 'i.kardys@erasmusmc.nl', 'phone': '+31650032051'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasmus Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ikazia Hospital, Rotterdam', 'class': 'OTHER'}, {'name': 'Franciscus Gasthuis & Vlietland (Hospital)', 'class': 'OTHER'}, {'name': 'OLVG', 'class': 'NETWORK'}, {'name': 'Free University Medical Center', 'class': 'OTHER'}, {'name': 'Noordwest Ziekenhuisgroep', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. dr., MD PhD', 'investigatorFullName': 'Isabella Kardys', 'investigatorAffiliation': 'Erasmus Medical Center'}}}}