Chemoreflex Sensitivity in HFpEF

Heart Failure With Preserved Ejection Fraction Clinical Trial

— CHEMO-HFpEF  

Official title:

Chemoreflex Sensitivity in Heart Failure With Preserved Ejection Fraction

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06309537
• Other study ID #: 09C830
• Status: Not yet recruiting
• Start date: October 2024
• Est. completion date: December 2029

Study information

• Verified date: March 2024
• Source: Istituto Auxologico Italiano
• Contact: Sergio Caravita, MD, PhD
• Phone: +39 02 619112930
• Email: s.caravita[@]auxologico.it
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2029
• Est. primary completion date: December 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Preserved Ejection Fraction

Intervention

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

Locations

Country	Name	City	State
Italy	Ospedale San Luca IRCCS Istituto Auxologico Italiano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	difference in chemoreflex sensitivity between HFpEF and healthy controls		5 years