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Sacubitril-Valsartan for Heart Failure in HIV
Study Summary
This trial is testing if therapies to reduce aldosterone and increase BNP levels may help improve heart health for people with HIV.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- Your heart's ability to squeeze and relax is less than 18%.My kidney function is reduced with creatinine over 1.5 mg/dL and GFR under 60.Your heart is too big for your body size.Your blood pressure is less than 100 mmHg.Your blood potassium level is higher than 5.5 milliequivalents per liter.You have had a bad reaction to gadolinium in the past.Your left atrium is too big for this study.You have had a serious allergic reaction to ACE inhibitors or ARBs.My liver isn't working well, or my ALT levels are high.Your HIV viral load must be less than 200 copies/mL.You are currently using drugs or alcohol in a way that is harmful.My diabetes is not under control and I need insulin or my HbA1c is above 7.5%.I am currently fighting an infection.I am currently taking medication for blood pressure or potassium supplements.I haven't used estrogen, progestin, or other sex steroids in the last 3 months.I have not had a heart attack or stroke in the last 3 months.I am taking medication that might not mix well with the study drug.I have been on antiretroviral therapy for more than a year.Your heart's pumping ability is lower than 50%.Your hemoglobin level is less than 10.0 grams per deciliter.I have a history of heart failure or heart valve disease.You have signs of heart problems on a heart ultrasound that show a specific type of heart failure.I have not taken steroids in the last 3 months.
- Group 1: Sacubitril/Valsartan
- Group 2: Placebo
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- 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 there still room for new participants in this clinical trial?
"That is correct, the listing on clinicaltrials.gov confirms that this study is currently seeking patients. The trial was originally posted on September 11th 2020 and was updated most recently on July 27th 2022. Only 50 participants are needed for this single-site study."
How can I become a part of this research?
"The prerequisites for this study are that patients must have AIDS and be between 40-70 years old. Out of the total pool of 50 participants, researchers are looking to enroll those who match these qualifications."
What health conditions is Sacubitril-Valsartan 49-51Mg Oral Tablet most effective in alleviating?
"Patients with left ventricular dysfunction, uncontrolled hypertension, and essential hypertension can be treated effectively using Sacubitril-Valsartan 49-51Mg Oral Tablets."
Is the lower age limit for this trial set at 18 years old?
"According to the eligibility requirements, patients must be between 40 and 70 years old in order to enroll. Out of 885 total clinical trials, this is the 48th trial for patients under 18 and the 839th for patients over 65."
Are there similar drugs to Sacubitril-Valsartan 49-51Mg Oral Tablet that have been studied in clinical trials?
"There are currently 39 ongoing clinical trials studying the effects of Sacubitril-Valsartan 49-51Mg Oral Tablet. Of those, 8 are in the third and final phase. The majority of research locations for this treatment are based in Montreal, Quebec; however, there are a total of 812 sites running studies worldwide."
Are there any dangers associated with taking Sacubitril-Valsartan 49-51Mg Oral Tablet?
"While there is limited data on the efficacy of Sacubitril-Valsartan, it has been deemed safe in Phase 2 trials and given a score of 2."
How many people are trialing this medication?
"Yes, the trial is currently enrolling patients. According to information on clinicaltrials.gov, the study was originally posted on September 11th 2020 and was last updated July 27th 2022. They are looking for 50 participants at 1 site."
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