- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03550235
Exploration of Dyspnea at Non-high Brain Natriuretic Peptide (BNP) (NEON HFpEF)
Exploration of Dyspnea at Non-high BNP
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).
Study Overview
Status
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Emmanuelle BERTHELOT, Dr
- Phone Number: 33145213735
- Email: emmanuelle.berthelot@aphp.Fr
Study Locations
-
-
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Le Kremlin-Bicêtre, France, 94270
- Recruiting
- Hôpital Bicêtre
-
Contact:
- Emmanuelle Berthelot, Dr
- Email: emmanuelle.berthelot@aphp.fr
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Poitiers, France, 86000
- Recruiting
- Polyclinique de Poitiers
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Contact:
- Barnabas GELLEN, Dr
- Email: barnabas.gellen.cardio@gmail.com
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Rennes, France, 35000
- Not yet recruiting
- CHU Pontchaillou
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Contact:
- Erwan Donal, Pr
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Toulouse, France, 31059 Toulouse Cedex 9
- Recruiting
- CCM RANGUEIL - LARREY CHU toulouse
-
Contact:
- Olivier Lairez, Pr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Occurence of HFpEF
Time Frame: during the 2 years of follow-up
|
HFpEF diagnosis will be made in attendance of following symptoms:
|
during the 2 years of follow-up
|
dyspnea on exertion
Time Frame: during the 2 years of follow-up
|
during the 2 years of follow-up
|
|
NTproBNP levels at rest
Time Frame: during the 2 years of follow-up
|
during the 2 years of follow-up
|
Collaborators and Investigators
Investigators
- Principal Investigator: Emmanuelle BERTHELOT, Dr, AP-HP Hôpital Bicêtre
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-A01621-52
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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