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Randomized Arm- Treatment Arm for Heart Failure

N/A
Recruiting
Research Sponsored by Endotronix, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female, at least 18 years of age
HFrEF (EF < 50%): Subject has been on stable medications maximized to the subject's tolerance of ACE-I or ARB or ARNI, MRA, beta-blockers, and SGLT2i as determined by the study investigator for at least 30 days prior to randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months and 24 months
Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of the Cordella Pulmonary Artery Sensor System in patients with heart failure. There are five groups in the study, each with a different approach to using the

Who is the study for?
This trial is for adults with heart failure who've been treated for at least 3 months and are in NYHA Class II or III. They should be on stable heart failure medication as per guidelines, though exceptions can be made if they're intolerant or cannot afford these medications. Recent hospitalization for heart failure and certain levels of NT-proBNP (a heart stress marker) are also required.Check my eligibility
What is being tested?
The PROACTIVE-HF-2 Trial is testing the Cordella™ Pulmonary Artery Sensor System's safety and effectiveness in patients with different severities of heart failure. It includes five groups: some getting the device, others serving as controls, and a group that switches from control to treatment.See study design
What are the potential side effects?
While specific side effects aren't listed here, similar devices may cause complications like infection risk at the implant site, bleeding during implantation procedure, blood vessel damage, arrhythmias (irregular heartbeat), or sensor malfunction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have heart failure with reduced ejection fraction and have been on stable heart medications for at least 30 days.
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I have been on stable heart failure medication as per guidelines for over 30 days.
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I have heart failure with preserved ejection fraction and have been on stable SGLT2 inhibitors for at least 30 days.
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My heart functions well but I have high levels of a heart failure marker.
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I have been on a water pill (like furosemide 40 mg or more) for at least a month.
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I have been diagnosed and treated for heart failure for at least 3 months and am classified as NYHA Class II or III.
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I have been hospitalized or needed urgent care for heart failure within the last 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months and 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months and 24 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
Efficacy- Randomized Arm - A composite of first HF event or death from Cardiovascular Death up to 24 months.
Efficacy- Single Arm- 12 month incidence of HF related Hospitalizations (HFH) or all-cause mortality
Safety- Randomized Arm- Freedom from device/system related complication
+3 more
Secondary outcome measures
Eff-Rando and SA -time to death, # HFH or urgent HF visits, time to first HFH or urgent HF visit, diff >/= 15 KCCQ BSL to 24 mos,diff >/= 10 in KCCQ BSL to 24 mos, diff >/= 5 in KCCQ BSL to 24 mos, diff >/= 30m in 6 MWT BSL to 24 mos
Efficacy - Randomized Arm - Incidence of HF hospitalizations or all-cause mortality
Efficacy - Randomized and SIngle Arm - Various measurements via ECHO and evaluated by ECHO core lab at Baseline, 12, 24, 36, 48 and 60 months.
+23 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: Single Arm- Clinician-Directed Patient Self-Management ArmExperimental Treatment1 Intervention
All subjects will receive the Cordella Sensor. Subjects will self-manage their Loop diuretics per protocol specific Clinician-Directed Patient Self-Management Treatment Guidelines and Clinicians will manage the patients according to Guideline-Directed Medical Therapy.
Group II: Single Arm- Clinician Management ArmExperimental Treatment1 Intervention
All subjects will receive the Cordella Sensor. Clinicians will manage the subjects to target PAP per protocols specific Treatment Guidelines and according to Guideline-Directed Medical Therapy.
Group III: Randomized Arm- Treatment ArmExperimental Treatment1 Intervention
All subjects will receive the Cordella Sensor. Clinicians will manage the subjects to target PAP per protocols specific Treatment Guidelines and according to Guideline-Directed Medical Therapy.
Group IV: Randomized Arm- Crossover ArmExperimental Treatment1 Intervention
All subjects will receive the Cordella Sensor. At least 12 months following implant and following an adjudicated HFH, subjects in the Active Control Arm can qualify to crossover to the Crossover Arm and both patients and clinicians would then be unmasked to PAP. Clinicians will then manage the subjects to target PAP per protocols specific Treatment Guidelines and according to Guideline-Directed Medical Therapy.
Group V: Randomized Arm- Active Control ArmExperimental Treatment1 Intervention
All subjects will receive the Cordella Sensor. Clinicians will manage subjects using the subjects daily data trends (BP, weight, HR, SpO2 symptoms) according to Guideline Directed Medical Therapy.

Find a Location

Who is running the clinical trial?

Endotronix, Inc.Lead Sponsor
4 Previous Clinical Trials
560 Total Patients Enrolled
4 Trials studying Heart Failure
560 Patients Enrolled for Heart Failure
Andrea SauerlandStudy DirectorEndotronix, Inc.
4 Previous Clinical Trials
560 Total Patients Enrolled
4 Trials studying Heart Failure
560 Patients Enrolled for Heart Failure

Frequently Asked Questions

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

Are there any available positions for patients to participate in this clinical trial?

"Indeed, the information available on clinicaltrials.gov indicates that this trial is actively seeking individuals to participate. The initial posting of the trial took place on November 29th, 2023 and it was most recently updated on December 21st, 2023. Across five different locations or sites, a total of 1650 participants are being sought for enrollment in the study."

Answered by AI

In the Canadian region, are there numerous medical facilities currently conducting this study?

"Patients are currently being enrolled at Methodist San Antonio in Texas, Heart Care Centers of Illinois (HCCI) in Palos Park, Illinois, and Ascension Sacred Heart in Pensacola, Florida. Furthermore, the trial is also taking place at five additional undisclosed locations."

Answered by AI

What is the current number of individuals enrolled in this clinical research study?

"To adequately conduct this study, a total of 1650 individuals who meet the eligibility criteria are needed. The trial will be overseen by the sponsor, Endotronix Inc., and conducted at various locations including Methodist San Antonio in San Antonio, Texas and Heart Care Centers of Illinois (HCCI) in Palos Park, Illinois."

Answered by AI

What are the intended results that researchers hope to achieve through this medical study?

"The main objective of this study, spanning approximately 24 months, is to evaluate the safety and freedom from device/system related complications in the randomized arm. Secondary outcomes include assessing efficacy through HF hospitalizations (length of stay), functional status improvement as measured by NYHA classification and 6MWT, and safety with regards to freedom from device/system related complications at 12 months."

Answered by AI
~1100 spots leftby Sep 2027