β-blockers Withdrawal in Patients With HFpEF and Chronotropic Incompetence: Effect on Functional Capacity (Preserve-HR)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2021-02-27

Brief Summary

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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

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Detailed Description

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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 (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 \[alfa: 0.05, power: 90%, a 15% loss rate, and delta change of mean peakVO2: +1.2 mL/kg/min (SD±2.5)\] 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.

Conditions

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Heart Failure With Normal Ejection Fraction Chronotropic Incompetence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 (peakVO2) will be assessed by 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 \[alfa: 0.05, power: 90%, a 15% loss rate, and delta change of mean peakVO2: +1.2 mL/kg/min (SD±2.5)\] of 52 patients would be necessary to test our hypothesis.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

The examination tests will be performed by two blinded cardiologist to patients' allocation group

Study Groups

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Arm A

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

Group Type ACTIVE_COMPARATOR

Controlled withdrawal of beta-blockers

Intervention Type DRUG

Controlled withdrawal of previos doses of beta-blockers after diagnosis of chronotropic incompetence

Cardiopulmonary Exercise Testing

Intervention Type DIAGNOSTIC_TEST

Cardiopulmonary Exercise Testing to evaluate the chronotropic incompetence and the primary endpoint (functional capacity)

Arm B

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.

Group Type ACTIVE_COMPARATOR

Controlled withdrawal of beta-blockers

Intervention Type DRUG

Controlled withdrawal of previos doses of beta-blockers after diagnosis of chronotropic incompetence

Cardiopulmonary Exercise Testing

Intervention Type DIAGNOSTIC_TEST

Cardiopulmonary Exercise Testing to evaluate the chronotropic incompetence and the primary endpoint (functional capacity)

Interventions

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Controlled withdrawal of beta-blockers

Controlled withdrawal of previos doses of beta-blockers after diagnosis of chronotropic incompetence

Intervention Type DRUG

Cardiopulmonary Exercise Testing

Cardiopulmonary Exercise Testing to evaluate the chronotropic incompetence and the primary endpoint (functional capacity)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No