Chemoreflex Sensitivity in HFpEF

NCT ID: NCT06309537

Last Updated: 2024-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-31

Study Completion Date

2029-12-31

Brief Summary

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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

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Conditions

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Heart Failure With Preserved Ejection Fraction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HFpEF

symptomatic patients with heart failure with preserved ejection fraction

chemoreflex evaluation

Intervention Type DIAGNOSTIC_TEST

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

asymptomatic PH-LHD

asymptomatic left ventricular diastolic dysfunction with echocardiographic signs of pulmonary hypertension

chemoreflex evaluation

Intervention Type DIAGNOSTIC_TEST

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

healthy volonteers

chemoreflex evaluation

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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chemoreflex evaluation

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istituto Auxologico Italiano

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ospedale San Luca IRCCS Istituto Auxologico Italiano

Milan, , Italy

Site Status

Countries

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Italy

Central Contacts

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Sergio Caravita, MD, PhD

Role: CONTACT

+39 02 619112930

Other Identifiers

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09C830

Identifier Type: -

Identifier Source: org_study_id

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