Effects of a Supervised Training Program on Functional Capacity in Patients With HFpEF and Chronotropic Incompetence
Launched by FUNDACIÓN PARA LA INVESTIGACIÓN DEL HOSPITAL CLÍNICO DE VALENCIA · Dec 5, 2022
Trial Information
Current as of February 05, 2025
Active, not recruiting
Keywords
ClinConnect Summary
Heart failure with preserved ejection fraction (HFpEF) is a highly prevalent clinical entity that predominantly affects women \>60 years old, whose incidence has increased in the last decade and has a complex and multifactorial pathophysiology. Chronotropic incompetence (CrI) has emerged as a crucial mechanism, particularly in patients older than 60 years, and is associated with more significant functional impairment. Supervised training programs in patients with heart failure and reduced ejection fraction and CrI have improved functional capacity and chronotropic response. However, we do n...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Patients diagnosed with heart failure with preserved ejection fraction according to 2021 ESC guidelines for Heart Failure.
- • N-terminal pro-B-type natriuretic peptide (NT-proBNP) \>125 pg/mL in the last month
- • Stable symptomatic heart failure patients (New York Heart Association functional class II-III/IV) during the last month
- • Age ≥ 60 years old.
- • Blunted heart rate (HR) response during a maximal cardiopulmonary exercise testing (CPET), defined as a chronotropic index \<0.62 if previous treatment with Beta-blockers or chronotropic index \<0.80 in patients without beta-blockers. Chronotropic index= \[HRpeak exercise - HRrest\] / \[220 - age - HRrest\]
- Exclusion Criteria:
- • Inability to perform a valid baseline cardiopulmonary exercise test
- • Cardiac pacemaker
- • Significant primary moderate-to-severe valve disease
- • Effort angina or signs of ischemia during CPET
- • Primary cardiomyopathies
- • Cardiac transplantation
- • Any other comorbidity with a life expectancy of less than one year
Trial Officials
Patricia Palau, MD, PhD
Principal Investigator
INCLIVA
About Fundación Para La Investigación Del Hospital Clínico De Valencia
The Fundación para la Investigación del Hospital Clínico de Valencia is a prominent research organization dedicated to advancing medical knowledge and improving patient care through clinical trials and biomedical research. Based in Valencia, Spain, the foundation collaborates closely with the Hospital Clínico Universitario de Valencia to facilitate innovative studies across various medical disciplines. Its mission is to promote scientific excellence and foster collaboration among healthcare professionals, researchers, and institutions, ultimately aiming to translate research findings into effective therapies and interventions for the benefit of patients and the broader community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Valencia, , Spain
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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