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NCT Number: NCT06309537

Chemoreflex Sensitivity in HFpEF

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.

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Key information

Conditions

Heart Failure With Preserved Ejection Fraction

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale San Luca IRCCS Istituto Auxologico Italiano

Milan, 20149, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

chemoreflex evaluation

Diagnostic Test

the ventilatory response to carbon dioxide and hypoxia will be assessed in study participants

Primary outcomes

  1. difference in chemoreflex sensitivity between HFpEF and healthy controls

    Time frame: 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Sergio Caravita, MD, PhD

CONTACT

[email protected]

+39 02 619112930

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Registry information

Official study title

Chemoreflex Sensitivity in Heart Failure With Preserved Ejection Fraction

Acronym: CHEMO-HFpEF

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Mar 13, 2024
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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