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Search / Trial NCT05649787

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

Heart Failure With Preserved Ejection Fraction Chronotropic Incompetence Functional Capacity

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.

Locations

Valencia, , Spain

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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