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Not yet recruiting NCT06309537

Chemoreflex Sensitivity in HFpEF

Observational Heart Failure With Preserved Ejection Fraction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: chemoreflex evaluation.
Who it may be relevant to
Registry conditions: Heart Failure With Preserved Ejection Fraction. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Chemoreflex Sensitivity in Heart Failure With Preserved Ejection Fraction

Overview

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.

Interventions

  • Diagnostic test chemoreflex evaluation
    the ventilatory response to carbon dioxide and hypoxia will be assessed in study participants

Primary outcome measures

  • difference in chemoreflex sensitivity between HFpEF and healthy controls [Time frame: 5 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Ospedale San Luca IRCCS Istituto Auxologico Italiano — Milan

Identifiers

NCT: NCT06309537 · 09C830

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗