Heart attack (myocardial infarction), illustration. A blocked coronary artery has led to heart muscle damage. Getty Images
Heart attack (myocardial infarction), illustration. A blocked coronary artery has led to heart muscle damage. Getty Images
June 1, 2022 — Recardio‘s Phase 2 trial results demonstrated the excellent safety profile of its lead drug Dutogliptin along with data suggesting potential positive effects on cardiac function and were presented in May at the World Congress on Acute Heart Failure 2022 in Madrid. Along with data suggesting potential positive effects on cardiac function, it was concluded that a pivotal study of this therapeutic approach in a large, adequately powered NDA-enabling study is warranted.
After reviewing the Phase 2 trial results, the FDA agreed with the proposed trial design and sample size for the pivotal Phase 3 trial of Dutogliptin in co-adminstration with filgrastim in early recovery post-myocardial infarction. A comparable agreement was also reached with the EMA.
The global pivotal trial, named HEAL-MI, will enroll 4,000 acute myocardial infarction patients with STEMI but not specified left ventricular ejection fraction (LVEF) and with facilitated screening procedures, which will accelerate the total enrollment. The primary endpoint is a combined clinical endpoint with a Quality-of-Life evaluation as a secondary endpoint.
Based on this advice, preparations are already under way for the trial that is intended to start in the course of 2022 and will enroll patients in the key global regions – US, Europe and China.
Dr. Roman Schenk, Recardio President commented: “We appreciate the positive agency feedback and are looking forward to contributing with this HEAL-MI pivotal trial to further therapeutic options for the respective patients with myocardial infarction.”
June 1, 2022 — Recardio‘s Phase 2 trial results demonstrated the excellent safety profile of its lead drug Dutogliptin along with data suggesting potential positive effects on cardiac function and were presented in May at the World Congress on Acute Heart Failure 2022 in Madrid. Along with data suggesting potential positive effects on cardiac function, it was concluded that a pivotal study of this therapeutic approach in a large, adequately powered NDA-enabling study is warranted.
After reviewing the Phase 2 trial results, the FDA agreed with the proposed trial design and sample size for the pivotal Phase 3 trial of Dutogliptin in co-adminstration with filgrastim in early recovery post-myocardial infarction. A comparable agreement was also reached with the EMA.
The global pivotal trial, named HEAL-MI, will enroll 4,000 acute myocardial infarction patients with STEMI but not specified left ventricular ejection fraction (LVEF) and with facilitated screening procedures, which will accelerate the total enrollment. The primary endpoint is a combined clinical endpoint with a Quality-of-Life evaluation as a secondary endpoint.
Based on this advice, preparations are already under way for the trial that is intended to start in the course of 2022 and will enroll patients in the key global regions – US, Europe and China.
Dr. Roman Schenk, Recardio President commented: “We appreciate the positive agency feedback and are looking forward to contributing with this HEAL-MI pivotal trial to further therapeutic options for the respective patients with myocardial infarction.
- Why are blood vessels responsible for 90% of your health?
- What settles on the walls of blood vessels besides cholesterol?
- 4 obvious and 7 hidden symptoms of unhealthy vessels
- How to safely clean blood vessels at home?
Why are blood vessels responsible for 90% of our health?
Mr. Sedrakyan, you have said several times that blood vessels are responsible for 90% of the health of our body. Why?
The total length of blood vessels in the human body is 2.5 times the length of the equator.
If you remove all the vessels from the body and connect them in sequence, you will get a ribbon with a length of more than 100 thousand km.
For comparison, let’s note that the length of the equator is 40 thousand km.
One of the most serious complications is hypertension, high blood pressure.
Remember, the health of the body is impossible without the health of the blood vessels.”
What settles on the walls of blood vessels besides cholesterol?
Everyone knows about the danger of cholesterol. It collects on the walls of blood vessels, which reduces the margin. This leads to impaired blood circulation. But this is not the only thing that accumulates in vessels.
6.1 kg –
total weight of impurities in blood vessels up to 50 years old
For comparison, if the diameter of the vessel is equal to the diameter of one finger, then 5 kg of cholesterol deposits narrow its margin to the diameter of 4 matches.
What symptoms indicate that our blood vessels need to be cleaned? How to understand the signal sent by the body: “Urgently clean the blood vessels”.
45
is a critical age, after which regular cleaning of vessels should be done.
The main symptom of vascular contamination is hypertension.
4 symptoms that indicate the contamination of vessels.
- 1. HypertensionUnstable high blood pressure that is reduced by medication.
- 2. Varicose veinsSwelling of the veins, swelling, heaviness and pain in the affected parts of the body. Deposits accumulated on the walls of blood vessels block the normal functioning of the venous valves, leading to deformation of the walls and expansion of the vein cavity.
- 3. HemorrhoidsVariety of varicose veins, enlargement of hemorrhoidal veins. The main symptom is rectal bleeding.
- 4. OsteochondrosisLack of nutrition of bone and cartilage tissue, premature wear of joints, lack of synovial fluid, unpleasant pains.
7 hidden symptoms.
- 1. SwellingIt is caused by a violation of the water-salt balance. Vessels blocked with non-elastic walls cannot remove the fluid that accumulates in tissues and organs. In the evening, the feet swell, shoes and socks leave deep marks around the toes and ankles, it becomes impossible to simply remove the ring. External swelling indicates internal, hidden swelling, which is much more dangerous for health.
- 2. In noisy placesFrom any sound, a significant decrease in concentration. Appears as a result of increased pressure in the blood vessels of the brain.
- 3. DizzinessEvidence of a violation of the vestibular apparatus. Often accompanied by hearing loss.
- 4. InsomniaDrowsiness, apathy, lack of energy, fatigue. Inability to sleep is caused by malnutrition of the pituitary gland, which stops producing melatonin, the sleep hormone.
- 5. Lack of energyLoss of strength, chronic fatigue in the morning. The reason is the lack of nutrients penetrating all tissues and organs and the narrowing of the margin in the vessels. The body goes into austerity mode to survive.
- 6. Visual impairmentBlurring, formation of spots in front of the eyes, which indicates damage to the eye vessels.
- 7. Pain in vesselsDifficulty moving, numbness of arms and legs, especially in the morning. It is provoked by a lack of nutrition and a change in the composition of the synovial fluid.
People can often have several of these symptoms at the same time. Sometimes they can be noticed even in one person.
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