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Dapagliflozin for Heart Failure
Study Summary
This trial will study whether the drug Dapa can help improve exercise endurance and muscle function in patients with heart failure.
- Heart Failure with Reduced Ejection Fraction
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You have taken a specific type of medication called SGLT2 inhibitor within the last 8 weeks and had a bad reaction to it.You have type 1 diabetes.Your hemoglobin level is less than 10 grams per deciliter.Your heart's pumping ability is less than 40%.You have a serious heart condition affecting the sac around the heart, as decided by the doctor.You have a specific type of high blood pressure in the arteries of your lungs called primary pulmonary artery hypertension.If your heart shows signs of ongoing strain during a strenuous exercise test, you cannot participate.You had a CRT device implanted in the past 12 weeks or plan to have one implanted during the study.You have had a heart transplant or a specific type of heart device implanted, or you are planning to get this type of device after joining the study.You have slow heart rate or certain heart block without a pacemaker.You have a serious liver disease that affects how your liver works.You have severe problems with the right side of your heart.Your blood pressure drops by more than 20 points when you stand up from lying down.Your kidneys are not working well, or your kidney disease is getting worse quickly.Your resting seated blood pressure is too high (above 180 mmHg) or too low (below 90 mmHg).You have been diagnosed with heart failure and have been in NYHA Class II-III for at least two months.You have had significant irregular heartbeats in the past 6 months or are planning to have a procedure to correct your heart rhythm in the next 6 months, except if you have had continuous irregular heartbeats and no normal heart rhythm in the past 6 months.You are not able or willing to do physical activity.You have significant problems with the valves on the left side of your heart or severe issues with the valves on the right side of your heart.You have certain heart conditions that affect the way your heart muscle works.Your blood test shows a certain level of NT-proBNP that indicates heart failure, or you have a history of hospitalization for heart failure, or you have atrial fibrillation/flutter shown on your ECG and your blood test shows a higher level of NT-proBNP.Your heart is beating too fast even when you are resting.You had a heart attack or heart procedure in the last 2 months.You currently have chest pain caused by heart artery disease, as determined by the doctor.You have severe chronic lung disease or have used oral steroids for lung problems in the past 6 months, or you currently use extra oxygen during the day for lung issues.If your oxygen level drops below 90% during a breathing and exercise test, you may not be able to join the study.You have a heart condition that causes reduced blood flow, as determined by a stress test, without further testing or treatment to confirm it's not a problem.
- Group 1: Placebo
- Group 2: Dapagliflozin 10mg
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is enrollment still open for this research project?
"Affirmative. The clinical trial database indicates that this medical research venture, initially uploaded on October 22nd 2021, is currently recruiting applicants. 27 participants must be found from a single site."
What primary health conditions is Dapagliflozin 10mg employed to alleviate?
"Dapagliflozin 10mg is often used in pharmaceutical formulations and, when combined with diet, exercise and other treatments, can help to alleviate conditions that have been insufficiently addressed by monotherapy."
Does this clinical study represent a pioneering approach?
"Presently, there are 63 clinical trials for Dapagliflozin 10mg spanning 50 countries and 235 cities. The inception of this research was in 2014 when AstraZeneca sponsored a study with 700 participants to assess the pharmaceutical's safety profiles. Since then, 18452 studies have been undertaken."
Is Dapagliflozin 10mg a safe dosage for human consumption?
"With limited data on efficacy, our team assigned a score of 2 to the safety profile of Dapagliflozin 10mg. This is due to this being a Phase 2 trial with some evidence supporting its security but not yet any indication of effectiveness."
How many participants are engaging in the experiment?
"Affirmative, the information on clinicaltrials.gov reveals that this trial is currently seeking participants. It was launched on October 22nd 2021 and last modified on October 27th 2021. The study necessitates a total of 27 patients from 1 site to be enrolled in it."
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