Angiotensin Receptor-Neprilysin Inhibitor

Sacubitril-Valsartan 49-51Mg Oral Tablet for Heart Failure

Phase 2
Recruiting
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Antiretroviral therapy use for >12 months
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up6 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions

Study Summary

This trial is testing if therapies to reduce aldosterone and increase BNP levels may help improve heart health for people with HIV.

Eligible Conditions
  • Diastolic Heart Failure
  • HIV/AIDS

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
You have been taking antiretroviral therapy for more than 12 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Left Atrial Volume Index
Myocardial Inflammation/Fibrosis
Secondary outcome measures
Cardiac Natriuretic Peptides
Indices of Myocardial Dysfunction
Markers of Myocardial Inflammation and Fibrosis

Awards & Highlights

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.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Sacubitril/ValsartanExperimental Treatment1 Intervention
Sacubitril/Valsartan 49-51mg twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 6 months
Group II: PlaceboPlacebo Group1 Intervention
Placebo twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 6 months

Find a site

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,832 Previous Clinical Trials
13,567,231 Total Patients Enrolled
47 Trials studying Heart Failure
209,485 Patients Enrolled for Heart Failure

Media Library

Sacubitril-Valsartan 49-51Mg Oral Tablet (Angiotensin Receptor-Neprilysin Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04153136 — Phase 2
Heart Failure Research Study Groups: Placebo, Sacubitril/Valsartan
Heart Failure Clinical Trial 2023: Sacubitril-Valsartan 49-51Mg Oral Tablet Highlights & Side Effects. Trial Name: NCT04153136 — Phase 2
Sacubitril-Valsartan 49-51Mg Oral Tablet (Angiotensin Receptor-Neprilysin Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04153136 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
Recent research and studies
~10 spots leftby Jun 2024