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Exploration of Dyspnea at Non-high Brain Natriuretic Peptide (BNP)

Exploration of Dyspnea at Non-high BNP

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03550235
Acronym
NEON HFpEF
Enrollment
100
Registered
2018-06-08
Start date
2018-10-08
Completion date
2022-11-30
Last updated
2019-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure With Preserved Ejection Fraction

Keywords

Heart failure, dyspnea, stress test

Brief summary

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).

Interventions

None listed

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Occurence of HFpEFduring the 2 years of follow-upHFpEF diagnosis will be made in attendance of following symptoms: * heart failure * NTproBNP\>125pg/ml * preservation of ejection fraction with Left Ventricular Ejection Fraction (LVEF)\>50% * 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
dyspnea on exertionduring the 2 years of follow-up
NTproBNP levels at restduring the 2 years of follow-up

Countries

France

Contacts

Primary ContactEmmanuelle BERTHELOT, Dr
emmanuelle.berthelot@aphp.Fr33145213735

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026