In short
This article explores the use of Dapagliflozin Propanediol Monohydrate in clinical trials, specifically focusing on its potential benefits for patients with acute heart failure. The drug, known commercially as Dapagliflozin, is being studied in a multicenter, randomized, double-blind trial to assess its effects when initiated during hospitalization for acute heart failure. The research aims to determine if early administration of Dapagliflozin can improve cardiovascular outcomes and reduce the risk of worsening heart failure in stabilized patients.
At a glance
- Study Title
- Dapagliflozin and Effect on Cardiovascular Events in Acute Heart Failure -Thrombolysis in Myocardial Infarction 68 (DAPA ACT HF-TIMI 68)
- Main Objective
- To assess the effect of in-hospital initiation of dapagliflozin on cardiovascular death or worsening heart failure in stabilized acute heart failure patients
- Study Design
- Multicenter, randomized, double-blind, parallel group, placebo-controlled trial
- Key Inclusion Criteria
- - Hospitalized for acute heart failure; - Left ventricular ejection fraction measured within past 12 months; - Elevated NT-proBNP or BNP during current hospitalization; - Stabilized patients (no increase in IV diuretics for 12 hours, no IV vasodilators/inotropes for 24 hours)
- Key Exclusion Criteria
- - Symptomatic hypotension in past 24 hours; - eGFR <25 ml/min/1.73 m2; - Current use of SGLT2 inhibitor; - Type 1 diabetes or history of diabetic ketoacidosis
- Primary Endpoints
- Time to first occurrence of cardiovascular death or worsening heart failure
- Secondary Endpoints
- - Symptomatic hypotension leading to hospitalization or study drug discontinuation; - Worsening renal function
- Drug Information
- Dapagliflozin Cipla 10 mg Film-coated Tablets
What is Dapagliflozin?
Dapagliflozin, also known by its full chemical name dapagliflozin propanediol monohydrate, is a medication that belongs to a class of drugs called SGLT2 inhibitors. It is primarily used to treat certain heart and kidney conditions, as well as type 2 diabetes. The medication is available as a film-coated tablet, typically in a 10 mg strength, and is taken orally (by mouth).
Medical Conditions Treated
Dapagliflozin is being studied for its effectiveness in treating acute heart failure. Heart failure is a condition where the heart cannot pump blood effectively to meet the body's needs. Acute heart failure refers to a sudden worsening of heart failure symptoms, often requiring hospitalization.
How Dapagliflozin Works
While the exact mechanism of action for heart failure is not fully explained in the provided information, SGLT2 inhibitors like dapagliflozin generally work by helping the kidneys remove excess sugar from the body through urine. This action can have beneficial effects on heart function and overall cardiovascular health.
Clinical Trial Overview
A large-scale clinical trial is being conducted to evaluate the effectiveness of dapagliflozin in patients with acute heart failure. The trial, named "DAPA ACT HF-TIMI 68," aims to assess the impact of starting dapagliflozin treatment in the hospital for patients who have been stabilized after admission for acute heart failure.
The main objective of this trial is to determine if dapagliflozin, compared to a placebo (a substance with no active medication), can reduce the risk of cardiovascular death or worsening heart failure in these patients.
Eligibility Criteria
To participate in this study, patients must meet certain criteria. Some key inclusion criteria are:
- Currently hospitalized for acute heart failure with symptoms like worsening breathlessness, fatigue, or swelling
- Showing signs of fluid overload, such as swollen neck veins or fluid in the lungs
- Receiving intensified heart failure treatment during the hospital stay
- Having a measured left ventricular ejection fraction (LVEF) within the past 12 months
- Showing elevated levels of certain heart failure markers in the blood (NT-proBNP or BNP)
There are also several exclusion criteria, including:
- Very low blood pressure in the past 24 hours
- Certain severe heart rhythm problems
- History of heart transplantation or being on a transplant list
- Severely reduced kidney function
- Current use of another SGLT2 inhibitor
- History of type 1 diabetes or diabetic ketoacidosis (a serious complication of diabetes)
Potential Benefits
The researchers hope that starting dapagliflozin treatment in the hospital for patients with acute heart failure might:
- Reduce the risk of dying from cardiovascular causes
- Decrease the chances of heart failure getting worse
- Lower the risk of being readmitted to the hospital for heart failure
- Reduce the need for urgent visits due to worsening heart failure
Safety Considerations
The trial is also designed to evaluate the safety and tolerability of starting dapagliflozin treatment in the hospital. Some specific safety concerns being monitored include:
- Low blood pressure that causes symptoms or requires hospitalization
- Worsening kidney function
- For patients with type 2 diabetes who are on insulin or certain diabetes medications, the risk of severe low blood sugar episodes
Administration
Dapagliflozin is typically taken as a once-daily oral tablet. In this study, the maximum daily dose is 10 mg. The treatment period in the trial may last up to 2 months, but this could vary depending on individual patient needs and responses.