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 个研究点目标入组 52 人开始时间: 2018年5月21日最近更新: 2018年6月18日

适应症

试验速览

暂无简介。

•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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 6
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 46

•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).
•11. Inability to perform an exercise test for osteoarticular problems.
•12. Patients on chronic treatment with digitalis or calciantagonistas type verapamil or diltiazem.
•13. Any type of disorder that compromises the subject's ability to give written consent and / or to comply with the study procedures.
•14. Pregnancy or lactation period.

发起方

Instituto de Investigación Sanitaria INCLIVA