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XXB750 for Heart Failure
Study Summary
This trial is testing a new medication to see if it is safe and effective for people with heart failure.
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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 a history of serious lung disease needing ongoing oxygen therapy or medicine for high blood pressure in the lungs.Your heart's pumping ability is less than 50% as shown in recent tests.Your blood pressure is between 110-160 mmHg for cohort 1 or 105-160 mmHg for cohort 2, and your heart rate is between 50-90 beats per minute.You have heart problems that affect your ability to do regular activities.You had severe heart failure in the last 3 months before the screening.You are currently taking a steady amount of sacubitril/valsartan.You have had a heart attack, stroke, or major heart or blood vessel surgery in the past 6 months.You have a serious problem with your heart valves, except for a specific type of problem with the mitral valve.You had a CRT device implanted within the last 3 months or plan to get one during the study.Your kidney function is less than 45 mL/min/1.73 m2.You are currently taking or have taken sacubitril/valsartan within the past 4 weeks.If you are taking a stable dose of ACE inhibitor or ARB, you can participate in Cohort 1.You are currently taking or have taken ACE inhibitors or ARB within the past 4 weeks.You have a very high body mass index (BMI).You are currently taking a consistent amount of a beta blocker.
- Group 1: XXB750 Cohort 1
- Group 2: Placebo Cohort 1
- Group 3: XXB750 Cohort 2
- Group 4: Placebo Cohort 2
- 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
Has the FDA sanctioned XXB750?
"As this is a Phase 1 trial, there's limited evidence to support the safety and efficacy of XXB750 - thus we rated it with a score of 1."
Does this controlled experiment include individuals over four decades old?
"This research project is only open to those between 18 and 78 years old. However, there are 22 studies available for people younger than 18 and 693 for seniors over 65."
Is the window for joining this experiment still available?
"Correct. The clinicaltrial.gov website confirms that this medical experiment, which was initially posted on May 17th 2022, is actively recruiting participants. There are 2 sites and the quota for enrollment is 27 patients in total."
How many individuals can participate in this clinical trial at its peak?
"Affirmative, the data hosted on clinicaltrials.gov proves that this trial is actively enrolling participants. This study was posted on May 17th 2022 and has since been revised on July 25th 2022. 27 patients must be recruited from 2 medical centres for the study to commence."
Am I able to join this clinical research endeavor?
"This clinical trial is accepting 27 patients, aged between 18 and 78, with adrenal gland hypofunction. Additional requirements include: NYHA functional class II-III, LVEF ≤ 45% as documented during screening phase, Systolic blood pressure ranging from 110 to 180 mmHg (cohort 1) or 105 -180 mmHg (cohort 2), heart rate no higher than 90 beats per minute; stabilised dosage of beta blockers for cohort 1 and ACE inhibitor/ARB for cohort 2; sacubitril/valsartan therapy prescribed on a stable dose in cohort two."
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