Chemoreflex Sensitivity in HFpEF

NCT06309537 | Not Yet Recruiting

• 1 other identifier: 09C830
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure With Preserved Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• difference in chemoreflex sensitivity between HFpEF and healthy controls

  5 years

Study Arms (3)

HFpEF

symptomatic patients with heart failure with preserved ejection fraction

Diagnostic Test: chemoreflex evaluation

asymptomatic PH-LHD

asymptomatic left ventricular diastolic dysfunction with echocardiographic signs of pulmonary hypertension

Diagnostic Test: chemoreflex evaluation

healthy volonteers

Diagnostic Test: chemoreflex evaluation

Interventions

chemoreflex evaluation DIAGNOSTIC_TEST

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

HFpEF; asymptomatic PH-LHD; healthy volonteers

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• breastfeeding or childbearing

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

Ospedale San Luca IRCCS Istituto Auxologico Italiano

Milan, 20149, Italy

Location

Central Study Contacts

Sergio Caravita, MD, PhD

CONTACT

+39 02 619112930; s.caravita@auxologico.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 13, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

IT (1)