Betablockers Withdrawal in Patients with Heart Failure with Preserved Ejection Fraction and Chronotropic Incompetence: Effect on Functional Capacity and life quality

Instituto de Investigación Sanitaria INCLIVA0 sites52 target enrollmentMay 21, 2018

Overview

No summary available.

Registry

who.int

Start Date

May 21, 2018

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Instituto de Investigación Sanitaria INCLIVA

•1\.Patients with IC\-FEP who meet the diagnostic criteria according to the current HF guidelines of the European Society of Cardiology:
•\- Typical signs and symptoms of HF.
•\- Systolic function of the left ventricle \=50% with non\-dilated left ventricle (end\-diastolic diameter \=60 mm, indexed end\-diastolic diameter\> 32 mm / m2 or indexed end\-diastolic volume\> 97 mL / m2\)
•\- Echocardiographic alteration compatible with relevant structural heart disease (hypertrophy of the left ventricle or dilatation of the left atrium) and / or diastolic dysfunction.
•2\. Stable functional class of NYHA II\-III the last month prior to inclusion.
•3\. Amino\-terminal fraction of the brain natriuretic pro\-peptide (NT\-proBNP)\> 125 pg / mL in the last month.
•4\. Chronotropic index, defined as (46\):
•5\. In current treatment and for more than 3 months with beta\-blockers.
•6\. Majority of age (\> 18 years).
•7\. The participant or his legal representative is willing and able to give informed consent for participation in the study

•1\. Diagnosis of left valvulopathy of moderate / severe degree considered to be mainly responsible for the symptoms.
•2\. History of coronary disease or presence of effort angina.
•3\. Basal HR\> 75 bpm.
•4\. Uncontrolled hypertension, with systolic blood pressure \> 140mmHg and diastolic blood pressure\> 90mmHg.
•5\. Patients undergoing cardiac transplantation or cardiac valve replacement in the last three months.
•6\. Primary cardiomyopathies.
•7\. Diagnosis of moderate\-severe pulmonary disease.
•8\. Any accompanying extracardiac comorbidity with life expectancy of less than 1 year.
•9\. Signs or symptoms of myocardial ischemia during the effort test with gas consumption.
•10\. Patient participating in another clinical trial or who has not yet completed at least 30 days from the completion of another clinical trial, or who is receiving another investigational agent (s).