BBLOQ-2017

Phase 1

• Conditions: Heart Failure; MedDRA version: 20.0Level: HLGTClassification code 10019280Term: Heart failuresSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-005077-39-ES
• Lead Sponsor: Instituto de Investigación Sanitaria INCLIVA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-21
• Last Update Posted: 18 June 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 52

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified