Heart Failure MedDRA version: 20.0 Level: HLGT Classification code 10019280 Term: Heart failures System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Pharmaceutical Form: Tablet
INN or Proposed INN: PROPRANOLOL HYDROCHLORIDE
CAS Number: 318-98-9
Other descriptive name: PROPRANOLOL HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type
Sponsors
Instituto de Investigación Sanitaria INCLIVA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of betablockers withdrawal in patients with HFpEF and chronotropic incompetence assessed by the peak oxygen consumption and heart rate at 15 and 30 days after the intervention.;Secondary Objective: Changes in: 1. Score in the quality of life questionnaire [Minnesota Living with Heart Failure Questionnaire (MLHFQ) 2. Functional class of the NYHA. 3. Echocardiographic parameters: a) diameters, volumes and systolic function of the left and right ventricle; b) diastolic function parameters (E / e ', e' media); c) systolic pulmonary arterial pressure; and, d) left atrial volume index. 4. Distance traveled in the six minute walk test (6MWT).Changes in submaximal functional capacity. 5. Ventilatory efficiency, estimated by the slope of the exhaled volume /CO2 elimination ratio throughout the test (VE/VCO2). 6. Maximum inspiratory pressure (PIM). 7. Plasma biomarkers: amino-terminal fraction of brain pro-natriuretic peptide (NT-proBNP), carbohydrate antigen 125 (CA125), ST-2 and Galectin-3 8. Average of the daily heart rate. 9. Global cognitive function through the miniexamen of mental state (MMSE) and the Montreal Cognitive Assessment (MoCa). 10. Fried's fragility index.;Primary end point(s): To evaluate the effect of betablockers withdrawal in patients with HFpEF and chronotropic incompetence assessed by the peak oxygen consumption and heart rate at 15 and 30 days after the intervention.;Timepoint(s) of evaluation of this end point: 15 and 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Changes in: 1. Score in the quality of life questionnaire [Minnesota Living with Heart Failure Questionnaire (MLHFQ) 2. Functional class of the NYHA. 3. Echocardiographic parameters: a) diameters, volumes and systolic function of the left and right ventricle; b) diastolic function parameters (E / e ', e' media); c) systolic pulmonary arterial pressure; and, d) left atrial volume index. 4. Distance traveled in the six minute walk test (6MWT).Changes in submaximal functional capacity. 5. Ventilatory efficiency, estimated by the slope of the exhaled volume /CO2 elimination ratio throughout the test (VE/VCO2). 6. Maximum inspiratory pressure (PIM). 7. Plasma biomarkers: amino-terminal fraction of brain pro-natriuretic peptide (NT-proBNP), carbohydrate antigen 125 (CA125), ST-2 and Galectin-3 8. Average of the daily heart rate. 9. Global cognitive function through the miniexamen of mental state (MMSE) and the Montreal Cognitive Assessment (MoCa). 10. Fried's fragility index.;Timepoint(s) of evaluation of this end point: 15 and 30 days | — |
Countries
Spain
Contacts
Public ContactScientific Subdirector
Instituto de Investigación Sanitaria INCLIVA
Outcome results
None listed