A multicentre, interventional, parallel group, randomised, open-label, exploratory study to assess the earlier introduction of Ivabradine in the Management of Systolic Dysfunction Heart Failure. The QUALIVA study
- Conditions
- Heart Failure with reduced ejection fraction and borderline systolic blood pressure.MedDRA version: 18.1 Level: SOC Classification code 10007541 Term: Cardiac disorders System Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2014-003286-21-IE
- Lead Sponsor
- niversity College Dublin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
•Recently prescribed the beta-blocker bisoprolol or carvedilol (a maximum of 4 weeks since initiating treatment and at least one week for bisoprolol and at least two weeks for carvedilol since the last BB dose adjustment with doses not greater than bisoprolol 5mg daily/carvedilol 12.5mg twice daily, to allow further up-titration)
•Willing to give written informed consent to participate in the study and to comply with the study procedures and restrictions during the study period.
•Male or female = 18 years
•Diagnosed with symptomatic HF-REF and LVEF = 40% (measured no longer than 3 months before the selection visit)
•Systolic CHF class II and III (NYHA class)
•No evidence of clinical decompensation
•Electrocardiographic documentation of sinus rhythm with resting heart rate = 70bpm
•SBP =120mmHg and =100mmHg
•Able to walk more than 450 meters within 6 minutes during inclusion visit (INCL)
•Recently prescribed the beta-blockers bisoprolol or carvedilol and undergoing BB titration (at least one week for bisoprolol and at least two weeks for carvedilol since the last BB dose adjustment), with dose not greater than bisoprolol 5mg daily/carvedilol 12.5mg twice daily, to allow further up-titration)
•Having completed other drug titration so as to confine the drug manipulation during the study period to a minimum (eg on full dose ACEi/ARB)
•ICD implantation is acceptable for inclusion. The presence of a CRT device will be assessed on a case by case basis
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 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•Participation in another study at the same time or within three months prior the selection visit (ASSE) for this study
•Unable to provide written informed consent
•Women who are pregnant or breast-feeding or women of child bearing potential not using estro-progestative oral or intra-uterine contraception or implants, or women using estro-progestative oral or intra-uterine contraception or implants but who consider stopping it during the planned duration of the study. Menopause will be defined as absence of menses for = 1 year.
•Current treatment with beta blocker other than bisoprolol or carvedilol
•Current treatment with ivabradine or previous treatment in the last 6 months
•Resting heart rate <70 beats per minute
•Able to walk more than 450 meters within 6 minutes during inclusion visit (INCL)
•History of drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements
•Known severe renal insufficiency with calculated creatinine clearance =15 mL/min/1.732
•Severe hepatic insufficiency
•Any other significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk by participation in the study, or may influence the result of the study
•Prior or concurrent malignancy within 5 years prior to starting the study treatment
•Known contraindication/allergy/sensitivity/intolerance to study medications or their ingredients (Ivabradine, Bisoprolol and/or Carvedilol)
•Documented permanent atrial fibrillation or other cardiac arrhythmia that interferes with the sinus node function, or recent hospitalisation for atrial fibrillation or other cardiac arrhythmia that interfere with the sinus node function within the last 3 months
•Severe hypotension (<90/50 mmHg)
•Cardiogenic shock
•Sick sinus syndrome, sino-atrial block, 2nd and 3rd degree AV-block
•Unstable or acute heart failure
•Unstable angina
•Recent myocardial infarction or coronary revascularisation (less than 2 months),
•Pacemaker dependent
•Other clinically significant ECG findings as judged by the investigator
•Patients with familial history or congenital or substance-induced long QT syndrome or treated with selected QT prolonging products (see section 12.9)
•Scheduled for procedures requiring general anaesthesia during the study
•Clinically significant abnormalities as judged by the investigator in haematology and biochemistry parameters. Special attention should be given to potentially significant abnormal values of the renal or liver function test
•Clinically significant findings as judged by the investigator during the procedures performed at the selection or inclusion visits
•Any treatment with unauthorised medications (see section 12.9) that could not be interrupted for the duration of the study
•Patients requiring a treatment that is unauthorised during the study or for whom such a treatment is considered
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method