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

NCT03550235 | Unknown

• 1 other identifier: 2017-A01621-52
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 4

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).

Conditions

Heart Failure With Preserved Ejection Fraction

Keywords

Heart failure; dyspnea; stress test

Outcome Measures

Primary Outcomes (3)

• 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

• dyspnea on exertion

  during the 2 years of follow-up

• NTproBNP levels at rest

  during the 2 years of follow-up

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All referred patients for unexplained dyspnea that must be assessed

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (4)

Hopital Bicêtre

Le Kremlin-Bicêtre, 94270, France

RECRUITING

Polyclinique de Poitiers

Poitiers, 86000, France

RECRUITING

CHU Pontchaillou

Rennes, 35000, France

NOT YET RECRUITING

CCM RANGUEIL - LARREY CHU toulouse

Toulouse, 31059 Toulouse Cedex 9, France

RECRUITING

MeSH Terms

Conditions

Heart Failure; Dyspnea

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Emmanuelle BERTHELOT, Dr

  AP-HP Hôpital Bicêtre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emmanuelle BERTHELOT, Dr

CONTACT

33145213735; emmanuelle.berthelot@aphp.Fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2018
• First Posted: June 8, 2018
• Study Start: October 8, 2018
• Primary Completion: October 1, 2020
• Study Completion: November 1, 2022
• Last Updated: December 17, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)