Clinical trial NCT03710057: Effect of Ivabradine in Lowering Heart Rate and Quality of Life in Chronic Heart Failure Patients
Official title: A Post-Marketing, Prospective, Observational Program: Effect of Ivabradrine in Lowering Heart Rate and Quality of Life in Chronic Heart Failure Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Heart Failure
Keywords: Ivabradine
Heart Rate
Health Related Quality of Life
Safety
Chronic Heart Failure Patient
Lead sponsor: Getz Pharma
Sponsor class: INDUSTRY
First posted: 2018-10-17
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population was included male or female patients with Chronic Heart Failure (CHF). Diagnosis of CHF as per Boston Criteria for Diagnosing Heart failure and the New York Heart Association (NYHA) functional class II to III classification and rest on the based on the medical judgment of the investigator after review of subject's medical history, results of routine screening physical and general examination and routine laboratory investigations.

Patients' written authorization was used to obtain patients' data. However, patient data secrecy was followed by ICH GCP requirements.

Brief summary: Elevated Heart rate (HR) (≥ 70 bpm) is one of the contributing factors in increasing the burden of hospitalization among Heart Failure patient. Ivabradine is a novel, selective and specific in inhibiting a Funny current in sinoatrial node Node and approved as an alternative therapy for Chronic Heart Failure (CHF) patients. CHF patients when treated with Ivabradine reported 39%, and 30% reduction in mortality and hospitalization rate respectively. Patient were treated with Ivabradine 5mg twice daily to determine its effect in lowering Heart rate and the Quality of Life (QOL) in Chronic Heart Failure patients

Detailed description: A prospective, post-marketing observational study was conducted in 50 chronic heart failure patients with age 30-70yrs of NYHA Class II and prescribed 5 mg Ivabradine twice daily. Heart rate was evaluated through ECG \& quality of life was measured by a validated questionnaire EuroQol-5 Dimension 3 level version (EQ-5D-3L). Baseline demographic includes age, gender, height, weight, Body Mass Index, temperature, blood pressure and respiratory rate were recorded and patients were followed at week 4 and week 8. Safety and tolerability was assessed by adverse drug reaction (ADR) monitoring. Results were analyzed by statistical software SPSS version 20.0.

Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Known case of Chronic Heart Failure (New York Heart Association (NYHA) functional class II to III)
* Clinically stability (at least for 4 weeks)
* Resting heart rate of more than 70 beats/ min (bpm) as assessed from the 12-lead electrocardiogram.

Exclusion Criteria:

* Hypersensitivity to the active substance or to any of the excipients
* Resting heart rate below 70 beats per minute prior to treatment
* Cardiogenic shock
* Acute myocardial infarction
* Severe hypotension (\< 90/50 mmHg)
* Severe hepatic insufficiency
* Sick sinus syndrome
* Sino-atrial block
* Unstable or acute heart failure
* Pacemaker dependent (heart rate imposed exclusively by the pacemaker)
* Unstable angina
* Atrioventricular Block of 3rd degree
* The combination with a strong cytochrome P450 3A4 inhibitors such as azole antifungals (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone
* The combination with verapamil or diltiazem which are moderate CYP3A4 inhibitors with heart rate reducing properties.
* Pregnancy, lactation and women of child-bearing potential not using appropriate contraceptive measures

Primary outcomes:
measure: Mean difference of Heart Rate
timeFrame: at 4 week and 8 week
Secondary outcomes:
measure: Percentage of problems reported in EQ-5D descriptive system
timeFrame: at 4 week and 8 week
measure: Median score of EQ-5D visual analogue scale
timeFrame: at 4 week and 8 week
Other outcomes:
measure: Percentage of Reported Adverse Drug Reactions
timeFrame: upto 8 weeks
Locations:
Study officials:
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