In short
This article discusses the use of Ivabradine Hydrochloride in clinical trials, specifically focusing on its potential to control heart rate and improve survival in adults with septic shock. The drug, marketed as Procoralan, is being studied in a multi-center, randomized trial to assess its efficacy in managing tachycardia (rapid heart rate) associated with septic shock, a life-threatening condition caused by severe infection.
At a glance
- Drug Name
- Ivabradine Hydrochloride (Procoralan)
- Trial Type
- Phase III, randomized, placebo-controlled, double-blind, multi-arm, multi-stage
- Main Objective
- Assess efficacy in controlling heart rate and improving 28-day survival in septic shock patients
- Primary Endpoints
- 1. Percentage of patients with heart rate 80-94 bpm at 48 hours; 2. 28-day mortality
- Key Inclusion Criteria
- Adults (18+) with septic shock and heart rate ≥95 bpm
- Administration
- Film-coated tablet via enteral feeding tube
- Maximum Daily Dose
- 7.5 mg
- Maximum Treatment Period
- 14 days
- Secondary Objectives
- Assess drug tolerance, impact on organ function, and pharmacokinetics
What is Ivabradine Hydrochloride?
Ivabradine Hydrochloride, also known by its brand name Procoralan, is a medication primarily used in cardiology. It comes in the form of film-coated tablets and is designed to control heart rate. In this clinical trial, researchers are exploring its potential use in patients with septic shock, a severe condition that can be life-threatening.
Understanding Septic Shock
Septic shock is a serious medical condition that occurs when an infection in your body leads to dangerously low blood pressure. It's characterized by the body's inability to maintain adequate blood flow to organs, even after receiving fluids. In septic shock, patients often have a very high heart rate, which can strain the heart and potentially worsen outcomes.
Clinical Trial Overview
A large-scale clinical trial is being conducted to evaluate the effectiveness of Ivabradine Hydrochloride in patients with septic shock. This trial is: Multicentre: Conducted across multiple hospitals or medical centers Prospective: Following patients forward in time Randomized: Patients are randomly assigned to different treatment groups Placebo-controlled: Some patients receive a placebo (inactive substance) for comparison Double-blind: Neither the patients nor the researchers know who is receiving the actual drug Multi-arm: There are three groups - one placebo group and two Ivabradine groups
Who Can Participate in the Trial?
The trial is looking for participants who meet the following criteria: Adults aged 18 or older Have a proven or suspected infection Are in septic shock (low blood pressure that doesn't respond to fluid treatment and requires medication to maintain adequate blood pressure) for at least 2 hours but less than 24 hours Have a heart rate of 95 beats per minute or higher Are in sinus rhythm (normal heart rhythm)
Who Cannot Participate in the Trial?
Certain conditions may prevent participation in the trial. These include: Certain heart conditions like arrhythmias or conduction disorders Severe kidney or liver problems Inability to take medication by mouth or feeding tube High heart rate due to other conditions like hyperthyroidism or severe anemia Pregnancy or breastfeeding Known allergy to Ivabradine or its ingredients
Trial Objectives and Endpoints
The main goals of this trial are: To assess how well Ivabradine controls heart rate in patients with septic shock. Specifically, they want to see if it can keep the heart rate between 80-94 beats per minute. To determine if Ivabradine improves 28-day survival rates in these patients.
Secondary objectives include: Evaluating the safety and side effects of Ivabradine in this patient group Assessing how heart rate control affects other aspects of patient health, such as organ function and overall recovery Studying how the drug is processed in the body (pharmacokinetics) in patients with septic shock
Potential Benefits and Considerations
While the potential benefits of Ivabradine in septic shock are still being studied, the hope is that by controlling heart rate, it might help improve outcomes for patients with this serious condition. However, as with any medical treatment, there may be risks and side effects. The trial is designed to carefully monitor patients and assess both the benefits and any potential drawbacks of using Ivabradine in this new way.
It's important to note that participation in clinical trials is voluntary, and patients should discuss the potential risks and benefits with their healthcare providers before deciding to participate.