Angiotensin Receptor-Neprilysin Inhibitor

Sacubitril-valsartan for Heart Failure

Virginia Commonwealth University, Richmond, VA
Targeting 2 different conditionsSacubitril-valsartan +1 morePhase 1 & 2RecruitingLed by Wendy Bottinor, MDResearch Sponsored by Virginia Commonwealth University

Study Summary

This trial is testing a new heart failure medication in young adult cancer survivors.

Eligible Conditions
  • Heart Failure

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~27 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 27 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
Determine feasibility of recruitment to this pilot trial by evaluating the eligibility requirements among adult age survivors of cancer diagnosed at or before age 39 who have stage B heart failure.
Determine the feasibility of recruitment to this pilot trial by evaluating the eligibility requirements among adult age survivors of cancer diagnosed at or before age 39 who have stage B heart failure.
Determine tolerability of treatment with sacubitril-valsartan among adult age survivors of cancer diagnosed at or before age 39 who have stage B heart failure.
Secondary outcome measures
Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.

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.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2: ValsartanExperimental Treatment1 Intervention
Valsartan administered orally twice daily at a maximally tolerate dose (max dose 160mg twice daily)
Group II: Arm 1: Sacubitril-valsartanExperimental Treatment1 Intervention
Sacubitril-valsartan administered orally twice daily at a maximally tolerate dose (max dose 97mg/103mg twice daily).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Valsartan
FDA approved

Find a site

Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor
657 Previous Clinical Trials
379,430 Total Patients Enrolled
22 Trials studying Heart Failure
4,725 Patients Enrolled for Heart Failure
Wendy Bottinor, MDPrincipal Investigator
Virginia Commonwealth University

Media Library

Sacubitril-valsartan (Angiotensin Receptor-Neprilysin Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05194111 — Phase 1 & 2
Heart Failure Research Study Groups: Arm 1: Sacubitril-valsartan, Arm 2: Valsartan
Heart Failure Clinical Trial 2023: Sacubitril-valsartan Highlights & Side Effects. Trial Name: NCT05194111 — Phase 1 & 2
Sacubitril-valsartan (Angiotensin Receptor-Neprilysin Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05194111 — Phase 1 & 2

Frequently Asked Questions

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

Is enrollment still available for participants of this research?

"According to clinicaltrials.gov, this research endeavour is actively signing up participants; it was originally posted on March 9th 2022 and recently updated on May 6th 2022."

Answered by AI

In what medical conditions is Sacubitril-valsartan most commonly prescribed?

"Sacubitril-valsartan is typically prescribed to treat certain types of ventricular dysfunction, as well as essential hypertension that cannot be successfully managed using a single therapy. It can also serve prophylactically against cardiovascular events."

Answered by AI

Is participation in this medical study open to those under the age of 25?

"To be eligible for this research, potential participants must fall between the age of 18 and 120. Concomitantly, 23 clinical trials are available to those under 18 years old, while 720 studies can accomodate individuals over 65."

Answered by AI

What is the current participation rate of this research project?

"Indeed, according to the clinicaltrials.gov website, this medical trial is still in need of volunteers. It was first advertised on March 9th 2022 and has been recently updated as of May 6th 2022. The study requires 30 individuals from one location."

Answered by AI

What criteria must be fulfilled to join this medical research trial?

"The requirements for admission into this heart failure trial necessitate that patients are between 18 and 120 years old. The investigators hope to admit a total of 30 individuals."

Answered by AI

Have researchers conducted any prior research into the efficacy of Sacubitril-valsartan?

"At present, there are 37 studies being conducted pertaining to Sacubitril-valsartan. Of those active clinical trials, 8 have reached phase 3 status. While a majority of these investigations can be found in Montreal, Quebec, global participation serves as a testament to the reach and efficacy of this medication with 826 sites running related experiments."

Answered by AI
~10 spots leftby Jun 2024