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

December 16, 2019 updated by: Assistance Publique - Hôpitaux de Paris

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

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Le Kremlin-Bicêtre, France, 94270
      • Poitiers, France, 86000
      • Rennes, France, 35000
        • Not yet recruiting
        • CHU Pontchaillou
        • Contact:
          • Erwan Donal, Pr
      • Toulouse, France, 31059 Toulouse Cedex 9
        • Recruiting
        • CCM RANGUEIL - LARREY CHU toulouse
        • Contact:
          • Olivier Lairez, Pr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All referred patients for unexplained dyspnea that must be assessed

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:

  • 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
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Emmanuelle BERTHELOT, Dr, AP-HP Hôpital Bicêtre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 8, 2018

Primary Completion (ANTICIPATED)

October 1, 2020

Study Completion (ANTICIPATED)

November 1, 2022

Study Registration Dates

First Submitted

April 27, 2018

First Submitted That Met QC Criteria

May 25, 2018

First Posted (ACTUAL)

June 8, 2018

Study Record Updates

Last Update Posted (ACTUAL)

December 17, 2019

Last Update Submitted That Met QC Criteria

December 16, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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