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AC6 Gene Transfer in Patients With Reduced Left Ventricular Ejection Fraction Heart Failure | Clinical Trials | Clareo Health

WITHDRAWNPHASE3

AC6 Gene Transfer in Patients With Reduced Left Ventricular Ejection Fraction Heart Failure

Randomized, Phase 3, Placebo-Controlled Double-Blind, Multicenter Trial of a One Time Intracoronary Administration of Ad5.hAC6 Gene Transfer for Patients With Reduced Left Ventricular Heart Failure

NCT03360448•Renova Therapeutics

View on ClinicalTrials.gov

Summary

To determine the safety and efficacy of an intracoronary injection of adenovirus 5 encoding human adenylyl cyclase 6 (RT-100) in patients with heart failure with reduced left ventricular ejection fraction (HFrEF) in a Phase 3 clinical trial.

Detailed Description

This is a randomized, placebo-controlled, double-blinded Phase 3 clinical trial using a one-time intracoronary injection of Ad5.hAC6 (or placebo) to determine safety and efficacy in patients with documented HFrEF.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age 18 to 80 years, inclusive, with history of heart failure (HF).
•2. Current HF symptoms with NYHA Functional Classification Class II to IV (inclusive) at Screening (Visit 1).
•3. Currently receiving optimally tolerated standard of care HF medical therapy as defined by the American Heart Association (AHA)/American College of Cardiology (ACC) Heart Failure guidelines and Focused Update along with an angiotensin converting enzyme inhibitor (ACEi)/angiotensin II receptor blockers (ARB), diuretics and sacubitril/valsartan for 4 weeks or longer, without change in drug therapy or dosage regimen, prior to Visit 1 (and continued same HF therapy through Visit 2).
•4. Left Ventricular Ejection Fraction (LVEF) ≥ 10 to ≤ 35% as determined by Screening echocardiogram (ECHO).
•5. NT pro BNP ≥ 400 pg/mL.
•6. If subject has had coronary artery bypass surgery, then at least one conduit must be patent and therefore be amendable for test article.
•7. Women of child bearing capacity must have a negative pregnancy test before 2 days of test article administration and must not be currently breastfeeding or nursing, and female and male patients must be willing to use birth control for 12 weeks after test article administration if the female partner is of child bearing capacity. Acceptable methods of effective birth control include total sexual abstinence; a condom with spermicide (men) in combination with barrier methods (diaphragm, cervical cap or cervical sponge); hormonal birth control (oral or injectable contraceptives); intrauterine devices; or surgical sterilization (vasectomy and testing that shows there is no sperm in the semen for men and bilateral tubal ligation +/- oophorectomy for women).
•8. Willing to provide informed consent consistent with International Conference on Harmonisation Good Clinical Practices.

Exclusion Criteria

•1. Use of intravenous (IV) vasodilatory or inotropic therapy within 24 hours prior to Visit 2.
•2. Unstable angina within 3 months of Visit 1.
•3. Coronary revascularization planned or predicted within 6 months prior to Visit 1.
•4. Subjects who are candidates for revascularization are not considered appropriate for this trial; therefore, if a subject has Ischemia of viable myocardium \> 15% and is a candidate for revascularization, this subject would not be eligible to participate in this trial.
•5. Myocardial infarction within 6 months prior to Screening (Visit 1). Myocardial infarction is defined by documented evidence of a rise and/or fall of cardiac biomarker values (preferably cardiac troponin) with at least one value above the 99th percentile upper reference limit, and either ischemic symptoms, electrocardiogram changes, imaging evidence of loss of viable myocardium or new regional wall motion abnormality, or identification of an intracoronary thrombus by coronary angiography.
•6. Thrombocytopenia (\< 100,000 platelets/µL) or bleeding diathesis.
•7. Stroke or transient ischemic attack within 6 months prior to Screening (Visit 1).
•8. Use of sodium-glucose co-transporter 2 inhibitors used to treat type 2 diabetes mellitus.
•9. Cardiac:
•1. Biopsy documenting reversible cause of cardiomyopathy within 6 months of Visit 1 (Screening) if available as part of patient's prior cardiac history.
+33 more criteria

Key Dates

Start Date

June 1, 2019

Primary Completion Date

June 1, 2020

Completion Date

June 1, 2023

Last Updated

June 7, 2019

Conditions

Heart Failure

Interventions

Ad5.hAC6

DRUG

Placebo

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 7, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

AC6 Gene Transfer in Patients With Reduced Left Ventricular Ejection Fraction Heart Failure

Inclusion Criteria

Exclusion Criteria

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