Chemoreflex Sensitivity in HFpEF

Not yet recruiting

• Conditions: Heart Failure With Preserved Ejection Fraction
• Interventions: Diagnostic Test: chemoreflex evaluation

• Registration Number: NCT06309537
• Lead Sponsor: Istituto Auxologico Italiano

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-07
• Study First Submitted QC: 2024-03-07
• Last Update Submitted: 2024-03-07
• Study First Posted: 2024-03-13
• Last Update Posted: 2024-03-13
• Study Start: 2024-10
• Primary Completion: 2029-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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)

Read More

Exclusion Criteria

• breastfeeding or childbearing

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HFpEF	chemoreflex evaluation	symptomatic patients with heart failure with preserved ejection fraction
healthy volonteers	chemoreflex evaluation	-
asymptomatic PH-LHD	chemoreflex evaluation	asymptomatic left ventricular diastolic dysfunction with echocardiographic signs of pulmonary hypertension

Primary Outcome Measures

Name	Time	Method
difference in chemoreflex sensitivity between HFpEF and healthy controls	5 years

Trial Locations

Locations (1)

Ospedale San Luca IRCCS Istituto Auxologico Italiano; 🇮🇹 Milan, Italy