Status:
COMPLETED
Ivabradine in Patients With Congestive Heart Failure
Lead Sponsor:
Damanhour University
Conditions:
Congestive Heart Failure
Eligibility:
All Genders
30-70 years
Phase:
PHASE4
Brief Summary
The aim of this study is to assess the efficacy of Ivabradine therapy in patients with congestive heart failure using the cardiac biomarkers NT-Pro BNP and Neopterin.
Detailed Description
* Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University * All participants have agreed to take part in this clinical study and provide informed consent ...
Eligibility Criteria
Inclusion
- Patients with chronic HF, on optimized medical therapy according to European Society of Cardiol¬ogy guidelines, with LV ejection fraction (LVEF) \< 35% according to the Simpson method, New York Heart Association (NYHA) class II-III, and sinus rhythm and resting HR \> 70/min were eligible for inclusion in the study.
Exclusion
- acute decompen¬sation (acute coronary syndromes and acute HF);
- hemodynamically significant valve disease;
- cer¬ebrovascular events during the previous 6 months;
- dysfunctional prosthetic heart valve;
- obstructive or non-obstructive cardiomyopathy; uncorrected congenital heart disease; active myocarditis;
- a his¬tory of resuscitation from sudden death; an absence of stable sinus rhythm, severe arrhythmias; HR \< 60 bpm; sick sinus syndrome; second-degree and third-degree atrioventricular block;
- severe obesity (body mass index \> 36 kg/m²);
- established or sus¬pected pulmonary diseases (vital capacity \< 80% or forced expiratory volume in 1 s \< 80% of age spe¬cific and sex-specific reference values);
- hemoglobin ≤ 11 g/dL;
- treatment with non-dihydropyridine calcium-channel blockers, class I antiarrhythmic agents, strong inhibitors of cytochrome P450-3A4, or QT interval-prolonging medications;
- acute and chronic kidney failure;
- pregnancy; hypo- and hy¬perthyroidism or acute infections.
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 5 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04448899
Start Date
June 1 2020
End Date
February 5 2021
Last Update
August 4 2021
Active Locations (1)
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1
Tanta University Hospital
Tanta, El-Gharbia, Egypt, 31527