Chemoreflex Sensitivity in HFpEF (CHEMO-HFpEF)

March 7, 2024 updated by: Istituto Auxologico Italiano

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.

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

60

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

  • Italy
      • Milan, Italy, 20149
        • Ospedale San Luca IRCCS Istituto Auxologico Italiano

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

  • diagnosis of symptomatic HFpEF (group 1)
  • diagnosis of asymptomatic left ventricular diastolic dysfunction with echocardiographic signs of PH (group 2)
  • healthy volunteers (group 3)

Exclusion Criteria:

  • breastfeeding or childbearing

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HFpEF
symptomatic patients with heart failure with preserved ejection fraction
Diagnostic test: chemoreflex evaluation
the ventilatory response to carbon dioxide and hypoxia will be assessed in study participants
asymptomatic PH-LHD
asymptomatic left ventricular diastolic dysfunction with echocardiographic signs of pulmonary hypertension
Diagnostic test: chemoreflex evaluation
the ventilatory response to carbon dioxide and hypoxia will be assessed in study participants
healthy volonteers
Diagnostic test: chemoreflex evaluation
the ventilatory response to carbon dioxide and hypoxia will be assessed in study participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
difference in chemoreflex sensitivity between HFpEF and healthy controls
Time Frame: 5 years
5 years

Collaborators and Investigators

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

Sponsor

Istituto Auxologico Italiano

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 (Estimated)

October 1, 2024

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

March 7, 2024

First Submitted That Met QC Criteria

March 7, 2024

First Posted (Actual)

March 13, 2024

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09C830

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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