β-blockers Withdrawal in Patients With HFpEF and Chronotropic Incompetence: Effect on Functional Capacity (Preserve-HR) (Preserve-HR)
Heart Failure With Normal Ejection Fraction, Chronotropic Incompetence
About this trial
This is an interventional treatment trial for Heart Failure With Normal Ejection Fraction focused on measuring Heart failure with preserved ejection fraction, Chronotropic incompetence, Functional capacity, Quality of life
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- INCLIVA
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Arm A
Arm B
Controlled Withdrawal of Beta-blockers and Cardiopulmonary Exercise Testing (CPET) Patient will be assessed for chronotr0pic incompetence by CPET. If the patient exhibits chronotropic incompetence, we will reduce half dose of previous beta-blocker. A cardiologist will evaluate clinically the the patient and the heart rate in 3 days. If clinical and heart rate stability (below 90 bpm), the patients will withdraw the beta-blocker and will be assessed by CPET at 15-day. After second CPET, the patient will introduce the half-dose of beta-blocker and will be evaluated in 3 days. If clinical stability, the patient will introduce the previous dose of beta-blocker A third CPET will be performed at 15-day
Cardiopulmonary Exercise Testing (CPET) and Controlled Withdrawal of Beta-blockers Patient will be assessed for chronotropic incompetence by CPET.If the patient exhibits chronotropic incompetence, a cardiologist will evaluate clinically the patient and the heart rate in 3 days and will be assessed by CPET at 15-day. After second CPET, the patient will reduce half dose of previous beta-blocker. A cardiologist will evaluate clinically the the patient and the heart rate in 3 days. If clinical and heart rate stability (below 90 bpm), the patients will withdraw the beta-blocker and will be assessed by CPET at 15-day.