Informations générales (source: ClinicalTrials.gov)

NCT03550235 Statut inconnu
Exploration of Dyspnea at Non-high BNP
Observational
  • Dyspnée
  • Défaillance cardiaque
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
octobre 2018
novembre 2022
03 décembre 2025
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. A 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).

Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
AP-HP Assistance publique - Hôpitaux de Paris En recrutement IDF 13/12/2025 07:45:40  Contacter
AP-HP - Hôpital Bicêtre
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CCM RANGUEIL - LARREY CHU toulouse - 31059 Toulouse Cedex 9 - Toulouse - France Olivier Lairez, Pr En recrutement Contact (sur clinicalTrials)
CHU Pontchaillou - 35000 - Rennes - France Erwan Donal, Pr Recrutement non commencé Contact (sur clinicalTrials)
Hopital Bicêtre - 94270 - Le Kremlin-Bicêtre - France Emmanuelle Berthelot, Dr En recrutement Contact (sur clinicalTrials)
Polyclinique de Poitiers - 86000 - Poitiers - France Barnabas GELLEN, Dr En recrutement Contact (sur clinicalTrials)

Critères

Tous
Inclusion Criteria:

- Patient over 40 years of age, and under 80 years of age with unexplained effort
dyspnea, able to pedal.

- Echocardiographic ejection fraction > 50%

- NTproBNP < 220 pg/ml in < 75 years, and < 450 pg/ml in ≥ 75 years



- Patient with coronary, valve, hypertrophic, hypertensive, infiltrative,
constrictive, or rhythmic, significant and/or progressive heart disease.

BMI > 35 kg/m².

- Unstable patient (systolic blood pressure < 90 mmHg, resting pulse > 100 BPM) or
clinically congested (edema of the lower limbs, crackling in the lungs).

- Patient with Pulmonary function testing (EFR) showing significant respiratory
disease (FEV1/ vital capacity (CV) max < 0.7, total lung capacities (CPT)< LIN)

- Chronic renal failure with creatinine clearance < 30 ml/min (MDRD) or dialysis

- Patient with anemia (Hb < 12 g/dl)

- Patient with hypo or hyperthyroidism on thyreostimulating hormone (TSH) value

- Patient under justice safeguard measure or guardianship