Heart Failure With Preserved Ejection FractionNEON HFpEFNCT03550235
Exploration of Dyspnea at Non-high Brain Natriuretic Peptide (BNP)
An observational study of Heart Failure With Preserved Ejection Fraction, run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.
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). Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction
- How many people
- 100 participants
- Where
- 4 sitesFrance
- Study dates
- 8 Oct 2018to Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All referred patients for unexplained dyspnea that must be assessed
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
France4 sites, 4 recruiting
- Recruiting
Hopital Bicêtre
Le Kremlin-Bicêtre, 94270
Emmanuelle Berthelot, Dr, emmanuelle.berthelot@aphp.fr
- Recruiting
Polyclinique de Poitiers
Poitiers, 86000
Barnabas GELLEN, Dr, barnabas.gellen.cardio@gmail.com
- Not yet recruiting
CHU Pontchaillou
Rennes, 35000
Erwan Donal, Pr
- Recruiting
CCM RANGUEIL - LARREY CHU toulouse
Toulouse, 31059 Toulouse Cedex 9
Olivier Lairez, Pr
About this study
Official title: 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).
- Keywords
- Heart failure, dyspnea, stress test
- Medical subject headings
- Heart Failure, Dyspnea
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: during the 2 years of follow-up
dyspnea on exertion
Measured: during the 2 years of follow-up
NTproBNP levels at rest
Measured: during the 2 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start8 Oct 2018
- Primary completionOct 2020 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuelle BERTHELOT, Dr, Principal investigator, AP-HP Hôpital Bicêtre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03550235
- Sponsor's protocol ID
- 2017-A01621-52
- Acronym
- NEON HFpEF
- Status last verified
- Dec 2019
- First submitted
- 27 Apr 2018
- Last updated
- 17 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Dyspnea at Non-high BNP
- ClinicalTrials.gov ID
- NCT03550235
- Acronym / sponsor ID
- NEON HFpEF / 2017-A01621-52
- Keywords
- Heart failure, dyspnea, stress test
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 8 Oct 2018 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 8 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All referred patients for unexplained dyspnea that must be assessed
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
dyspnea on exertion
Time frame: during the 2 years of follow-up
NTproBNP levels at rest
Time frame: during the 2 years of follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuelle BERTHELOT, Dr principal investigator
AP-HP Hôpital Bicêtre
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure With Preserved Ejection Fraction, run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emmanuelle BERTHELOT, Dr (33145213735, emmanuelle.berthelot@aphp.Fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurence of HFpEF (time frame: during the 2 years of follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.