Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2025-12-25 @ 7:47 PM
Study NCT ID:
NCT03550235
Status:
UNKNOWN
Last Update Posted:
2019-12-17
First Post:
2018-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exploration of Dyspnea at Non-high Brain Natriuretic Peptide (BNP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D004417', 'term': 'Dyspnea'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2022-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-16', 'studyFirstSubmitDate': '2018-04-27', 'studyFirstSubmitQcDate': '2018-05-25', 'lastUpdatePostDateStruct': {'date': '2019-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurence of HFpEF', 'timeFrame': 'during the 2 years of follow-up', 'description': "HFpEF diagnosis will be made in attendance of following symptoms:\n\n* heart failure\n* NTproBNP\\>125pg/ml\n* preservation of ejection fraction with Left Ventricular Ejection Fraction (LVEF)\\>50%\n* structural heart disease with expansion of left ventricular mass (VM) (men: VM≥115 g/m² or women ≥ 95 g/m² and an E/e' ratio≥13"}, {'measure': 'dyspnea on exertion', 'timeFrame': 'during the 2 years of follow-up'}, {'measure': 'NTproBNP levels at rest', 'timeFrame': 'during the 2 years of follow-up'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart failure', 'dyspnea', 'stress test'], 'conditions': ['Heart Failure With Preserved Ejection Fraction']}, 'descriptionModule': {'briefSummary': "Patients with unexplained stress dyspnea ( ≥ stage 2 NYHA), no significant underlying lung disease, with an ejection fraction \\> 50%, normal resting filling pressures, NTproBNP \\< 220 pg/ml in \\< 75 years, and \\< 450 pg/ml in ≥ 75 years will be studied with stress echocardiography and cardiometabolic stress test (VO2). These patients may have abnormal adaptation during exercise, suggesting that chronic symptoms may be related to a heart failure with preserved ejection fraction (HFPEF). More accurate and earlier diagnosis of HFPEF using stress echocardiography and VO2 may better manage stress dyspnea in patients and prevent progression of HFPEF.\n\nA clinical assessment will be offered to people with unexplained stress dyspnea. The procedures and products used in this study are usually used as part of HFpEF's diagnostic strategy. During this assessment, carried out on an outpatient basis, an anamnesis collection, a cardiovascular clinical examination, an evaluation of dyspnea by the NYHA functional class and by 2 questionnaires, an electrocardiogram will be carried out, a 6-minute walk test, a biological blood test, a trans thoracic rest and stress cardiac ultrasound, respiratory functional tests (with diffusion capacity of lung for carbon monoxide (DLCO) and blood gas), and a metabolic stress test. A follow-up at 1 and 2 years is planned (visit, sampling and resting echocardiography)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All referred patients for unexplained dyspnea that must be assessed', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient over 40 years of age, and under 80 years of age with unexplained effort dyspnea, able to pedal.\n* Echocardiographic ejection fraction \\> 50%\n* NTproBNP \\< 220 pg/ml in \\< 75 years, and \\< 450 pg/ml in ≥ 75 years\n\nExclusion Criteria:\n\n* Patient with coronary, valve, hypertrophic, hypertensive, infiltrative, constrictive, or rhythmic, significant and/or progressive heart disease.\n\nBMI \\> 35 kg/m².\n\n* Unstable patient (systolic blood pressure \\< 90 mmHg, resting pulse \\> 100 BPM) or clinically congested (edema of the lower limbs, crackling in the lungs).\n* Patient with Pulmonary function testing (EFR) showing significant respiratory disease (FEV1/ vital capacity (CV) max \\< 0.7, total lung capacities (CPT)\\< LIN)\n* Chronic renal failure with creatinine clearance \\< 30 ml/min (MDRD) or dialysis\n* Patient with anemia (Hb \\< 12 g/dl)\n* Patient with hypo or hyperthyroidism on thyreostimulating hormone (TSH) value\n* Patient under justice safeguard measure or guardianship'}, 'identificationModule': {'nctId': 'NCT03550235', 'acronym': 'NEON HFpEF', 'briefTitle': 'Exploration of Dyspnea at Non-high Brain Natriuretic Peptide (BNP)', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Exploration of Dyspnea at Non-high BNP', 'orgStudyIdInfo': {'id': '2017-A01621-52'}}, 'contactsLocationsModule': {'locations': [{'zip': '94270', 'city': 'Le Kremlin-Bicêtre', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emmanuelle Berthelot, Dr', 'role': 'CONTACT', 'email': 'emmanuelle.berthelot@aphp.fr'}], 'facility': 'Hopital Bicêtre', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '86000', 'city': 'Poitiers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Barnabas GELLEN, Dr', 'role': 'CONTACT', 'email': 'barnabas.gellen.cardio@gmail.com'}], 'facility': 'Polyclinique de Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '35000', 'city': 'Rennes', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Erwan Donal, Pr', 'role': 'CONTACT'}], 'facility': 'CHU Pontchaillou', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '31059 Toulouse Cedex 9', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Olivier Lairez, Pr', 'role': 'CONTACT'}], 'facility': 'CCM RANGUEIL - LARREY CHU toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Emmanuelle BERTHELOT, Dr', 'role': 'CONTACT', 'email': 'emmanuelle.berthelot@aphp.Fr', 'phone': '33145213735'}], 'overallOfficials': [{'name': 'Emmanuelle BERTHELOT, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AP-HP Hôpital Bicêtre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}