Ignite Creation Date:
2024-05-06 @ 12:54 PM
Last Modification Date:
2024-10-26 @ 1:05 PM
Study NCT ID:
NCT03871803
Status:
COMPLETED
Last Update Posted:
2021-03-02
First Post:
2019-03-03
Brief Title:
β-blockers Withdrawal in Patients With HFpEF and Chronotropic Incompetence Effect on Functional Capacity Preserve-HR
Sponsor:
Fundación para la Investigación del Hospital Clínico de Valencia
Organization:
Fundación para la Investigación del Hospital Clínico de Valencia
Study Overview
Official Title:
Betablockers Withdrawal in Patients With Heart Failure With Preserved Ejection Fraction and Chronotropic Incompetence Effect on Functional Capacity Rationale and Study Design of a Prospective Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2020-07
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:
Preserve-HR
Brief Summary:
The pathophysiology of heart failure with preserved ejection fraction HFpEF is complex and multifactorial Chronotropic incompetence has emerged as a crucial mechanism particularly in elderly patients Betablockers drugs with negative chronotropic effect are commonly used in HFpEF despite current evidence does not support its routine use in these patients The aim of this work is to evaluate the effect of betablockers withdrawal in patients with HFpEF and chronotropic incompetence on functional capacity assessed by the peak oxygen consumption at maximal exercise peakVO2 at 15 and 30 days after the intervention
Detailed Description:
This is a prospective crossover randomized 11 and single center study After randomization clinical and cardiac rhythm will be continuously registered during 30 days The primary endpoint peakVO2 will be assessed by cardiopulmonary exercise testing CPET at 15 and 30-day in both groups Patients with HFpEF functional class NYHA II-III chronic treatment with betablockers and chronotropic incompetence will be enrolled A sample size estimation alfa 005 power 90 a 15 loss rate and delta change of mean peakVO2 12 mLkgmin SD25 of 52 patients would be necessary to test our hypothesis
In conclusion optimizing therapy that improve quality of life and autonomy has become a health care priority in HFpEF The investigators believe this study will add important knowledge for the treatment of a subgroup of HFpEF
In conclusion optimizing therapy that improve quality of life and autonomy has become a health care priority in HFpEF The investigators believe this study will add important knowledge for the treatment of a subgroup of HFpEF
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-005077-39 | EUDRACT_NUMBER | None | None |