Ignite Creation Date:
2024-05-06 @ 6:23 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05649787
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-15
First Post:
2022-11-22
Brief Title:
Effects of a Supervised Training Program on Functional Capacity in Patients With HFpEF and Chronotropic Incompetence
Sponsor:
Fundación para la Investigación del Hospital Clínico de Valencia
Organization:
Fundación para la Investigación del Hospital Clínico de Valencia
Study Overview
Official Title:
Effects of a Supervised Training Program on Functional Capacity in Patients With Heart Failure and Preserved Ejection Function and Chronotropic Incompetence
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Training-HR
Brief Summary:
This is a prospective study blinded for the evaluator randomized 1111 to receive standard management alone or combined with a program of training aerobic alone or combined with strength exercises that will be carried out in a single centre After randomization patients will be clinically evaluated The primary endpoint peakVO2 will be assessed by cardiopulmonary exercise testing CPET at 12 weeks Patients with heart failure with preserved ejection fraction functional class NYHA II-III and chronotropic incompetence criteria will be enrolled A sample size estimation alfa 005 power 80 a 15 loss rate and at least a delta change of mean peakVO2 24 mLkgmin SD2 of 80 patients 20 per arm would be necessary to test our hypothesis
Detailed Description:
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 not have evidence about the effects of a supervised training program on patients with HFpEF and CrI This work aims to evaluate the effect of a supervised exercise program for 12 weeks in patients with HFpEF and CrI on peak oxygen consumption peakVO2 and chronotropic response
This is a prospective study blinded for the evaluator randomized 1111 to receive standard management alone or combined with a program of training aerobic alone or combined with strength exercises that will be carried out in a single centre After randomization patients will be clinically evaluated The primary endpoint peakVO2 will be assessed by cardiopulmonary exercise testing CPET at 12 weeks Patients with HFpEF functional class NYHA II-III and CrI criteria will be enrolled A sample size estimation alfa 005 power 80 a 15 loss rate and at least a delta change of mean peakVO2 24 mLkgmin SD2 of 80 patients 20 per arm would be necessary to test our hypothesis
This is a prospective study blinded for the evaluator randomized 1111 to receive standard management alone or combined with a program of training aerobic alone or combined with strength exercises that will be carried out in a single centre After randomization patients will be clinically evaluated The primary endpoint peakVO2 will be assessed by cardiopulmonary exercise testing CPET at 12 weeks Patients with HFpEF functional class NYHA II-III and CrI criteria will be enrolled A sample size estimation alfa 005 power 80 a 15 loss rate and at least a delta change of mean peakVO2 24 mLkgmin SD2 of 80 patients 20 per arm would be necessary to test our hypothesis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None