Heart Failure With Preserved Ejection FractionCHEMO-HFpEFNCT06309537
Chemoreflex Sensitivity in HFpEF
An observational study of Heart Failure With Preserved Ejection Fraction, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial summary
Patients with heart failure and a preserved left ventricular ejection fraction (HFpEF) almost invariably complain of exertional breathlessness. Abnormal cardiac hemodynamics with pulmonary congestion are believed to trigger dyspnea in this patients. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction
- What is being tested?
- chemoreflex evaluation
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2024to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: we will include * symptomatic patients with a diagnosis of HFpEF * asymptomatic individuals with echocardiographic signs of PH attributable to left ventricular diastolic dysfynction * healthy controls
Who may be able to join
- diagnosis of symptomatic HFpEF (group 1)
- diagnosis of asymptomatic left ventricular diastolic dysfunction with echocardiographic signs of PH (group 2)
- healthy volunteers (group 3)
Who cannot join
- breastfeeding or childbearing
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Chemoreflex Sensitivity in Heart Failure With Preserved Ejection Fraction
Patients with heart failure and a preserved left ventricular ejection fraction (HFpEF) almost invariably complain of exertional breathlessness. Abnormal cardiac hemodynamics with pulmonary congestion are believed to trigger dyspnea in this patients. However, some patients may complain of exertional breathlessness which seems to be out of proportion as compared with hemodynamic abnormalities.
Chemoreflex sensitivity accounts for the ventilatory responses to a variety of chemical stimuli, including carbon dioxide produced by the organism during exercise. Chemoreflex sensitivity can be augmented in heart failure with reduced left ventricular ejection fraction, and an increased chemoreflex sensitivity has been linked to symptoms, neurohumoral activation, breathing disturbances, and adverse prognosis.
Read more
However, the clinical correlates and implications of chemoreflex sensitivity in HFpEF have not been accurately studied.
We aim to characterize chemoreflex sensitivity in patients with a diagnosis of HFpEF, and to correlate chemoreflex sensitivity with clinical and hemodynamic characteristics.
- Being tested
- chemoreflex evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemoreflex evaluationDiagnostic test
the ventilatory response to carbon dioxide and hypoxia will be assessed in study participants
| Study group | Role | What they receive |
|---|---|---|
| HFpEF | symptomatic patients with heart failure with preserved ejection fraction Receives: Diagnostic Test: chemoreflex evaluation | |
| asymptomatic PH-LHD | asymptomatic left ventricular diastolic dysfunction with echocardiographic signs of pulmonary hypertension Receives: Diagnostic Test: chemoreflex evaluation | |
| healthy volonteers | Not described Receives: Diagnostic Test: chemoreflex evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in chemoreflex sensitivity between HFpEF and healthy controls
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study startOct 2024 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309537
- Sponsor's protocol ID
- 09C830
- Acronym
- CHEMO-HFpEF
- Status last verified
- Mar 2024
- First submitted
- 7 Mar 2024
- Last updated
- 13 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemoreflex Sensitivity in Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT06309537
- Acronym / sponsor ID
- CHEMO-HFpEF / 09C830
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 13 Mar 2024 (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 heart failure and a preserved left ventricular ejection fraction (HFpEF) almost invariably complain of exertional breathlessness. Abnormal cardiac hemodynamics with pulmonary congestion are believed to trigger dyspnea in this patients. However, some patients may complain of exertional breathlessness which seems to be out of proportion as compared with hemodynamic abnormalities.
Chemoreflex sensitivity accounts for the ventilatory responses to a variety of chemical stimuli, including carbon dioxide produced by the organism during exercise. Chemoreflex sensitivity can be augmented in heart failure with reduced left ventricular ejection fraction, and an increased chemoreflex sensitivity has been linked to symptoms, neurohumoral activation, breathing disturbances, and adverse prognosis.
However, the clinical correlates and implications of chemoreflex sensitivity in HFpEF have not been accurately studied.
We aim to characterize chemoreflex sensitivity in patients with a diagnosis of HFpEF, and to correlate chemoreflex sensitivity with clinical and hemodynamic characteristics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HFpEF | – | Diagnostic Test: chemoreflex evaluationsymptomatic patients with heart failure with preserved ejection fraction |
| asymptomatic PH-LHD | – | Diagnostic Test: chemoreflex evaluationasymptomatic left ventricular diastolic dysfunction with echocardiographic signs of pulmonary hypertension |
| healthy volonteers | – | Diagnostic Test: chemoreflex evaluation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- we will include * symptomatic patients with a diagnosis of HFpEF * asymptomatic individuals with echocardiographic signs of PH attributable to left ventricular diastolic dysfynction * healthy controls
Key inclusion criteria (3 listed)
- diagnosis of symptomatic HFpEF (group 1)
- diagnosis of asymptomatic left ventricular diastolic dysfunction with echocardiographic signs of PH (group 2)
- healthy volunteers (group 3)
Key exclusion criteria (1 listed)
- breastfeeding or childbearing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chemoreflex evaluationthe ventilatory response to carbon dioxide and hypoxia will be assessed in study participants | Diagnostic test | HFpEF, asymptomatic PH-LHD, healthy volonteers |
Primary outcome
difference in chemoreflex sensitivity between HFpEF and healthy controls
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
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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.
1 site 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 Istituto Auxologico Italiano at 1 site in Italy.
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 1 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: opening soon, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sergio Caravita, MD, PhD (+39 02 619112930, s.caravita@auxologico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference in chemoreflex sensitivity between HFpEF and healthy controls (time frame: 5 years). 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 13 Mar 2024.