Status:
COMPLETED
β-blockers Withdrawal in Patients With HFpEF and Chronotropic Incompetence: Effect on Functional Capacity (Preserve-HR)
Lead Sponsor:
Fundación para la Investigación del Hospital Clínico de Valencia
Conditions:
Heart Failure With Normal Ejection Fraction
Chronotropic Incompetence
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 patie...
Detailed Description
This is a prospective, crossover, randomized (1:1) and single center study. After randomization, clinical and cardiac rhythm will be continuously registered during 30 days. The primary endpoint (peakV...
Eligibility Criteria
Inclusion
- Stable symptomatic patients with heart failure and preserved ejection fraction (NYHA class II-III).
- NT-proBNP \>125 pg/mL in the last month
- Previous treatment with beta-blockers during the last 3 months
- Documented chronotropic incompetence, defined as: \[(heart rate at peak exercise- heart rate at baseline)\] / \[(220 - age) - (heart rate at baseline)\] \< 0.62
Exclusion
- Moderate to severe valvulopathy or miocardiopathy associated
- Patient with heart failure with recovered ejection fraction
- Acute Coronary Syndrome in the previous 12 months
- Angina or signs of myocardial ischemia on cardiopulmonary exercise testing
- Baseline heart rate\>75 bpm.
- Uncontrolled hypertension, defined as \>140mmHg systolic blood pressure and/or \>90 mmHg diastolic blood pressure.
- Moderate to severe pulmonary disease associated
- Extracardiac comorbidity with a life expentancy less than 1 year.
- Unable to perform an adequate cardiopulmonary exersice test
- Previous treatment with digitalis or calcium channel blockers
Key Trial Info
Start Date :
October 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2021
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03871803
Start Date
October 1 2018
End Date
February 27 2021
Last Update
March 2 2021
Active Locations (1)
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1
INCLIVA
Valencia, Spain, 46010