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

Heart Failure With Preserved Ejection Fraction Clinical Trial

— NEON HFpEF  

Official title:

Exploration of Dyspnea at Non-high BNP

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03550235
• Other study ID #: 2017-A01621-52
• Status: Recruiting
• Start date: October 8, 2018
• Est. completion date: November 2022

Study information

• Verified date: December 2019
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Emmanuelle BERTHELOT, Dr
• Phone: 33145213735
• Email: emmanuelle.berthelot[@]aphp.Fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 2022
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyspnea
• Heart Failure
• Heart Failure With Preserved Ejection Fraction

Locations

Country	Name	City	State
France	Hopital Bicêtre	Le Kremlin-Bicêtre
France	Polyclinique de Poitiers	Poitiers
France	CHU Pontchaillou	Rennes
France	CCM RANGUEIL - LARREY CHU toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurence of HFpEF	HFpEF 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	during the 2 years of follow-up
Primary	dyspnea on exertion		during the 2 years of follow-up
Primary	NTproBNP levels at rest		during the 2 years of follow-up