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ARNI
Optimal Heart Failure Therapy for Heart Failure (COPILOT-HF Trial)
Phase 4
Recruiting
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented diagnosis of heart failure (e.g., ICD-9 codes 428 ICD-10 codes I50 or Problem list in the electronic health record)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-months following randomization
Awards & highlights
COPILOT-HF Trial Summary
This trial tests two strategies for optimizing medical treatments for heart failure patients, regardless of their heart's function.
Who is the study for?
This trial is for heart failure patients who have seen a Mass General Brigham provider in the last 2 years, with an EF assessment in the past 24 months, and speak English or Spanish. It's not for those with severe blood pressure issues, certain heart diseases like amyloidosis or pulmonary hypertension, very low kidney function, active chemotherapy treatment, end-of-life care recipients, transplant-related cases or those on specific heart support treatments.Check my eligibility
What is being tested?
The COPILOT-HF trial tests two remote care strategies to optimize prescriptions of guideline-directed medical therapies (like SGLT2i inhibitors and ARNI) for heart failure patients. The study randomly assigns participants to different treatment approaches and monitors them remotely within the healthcare system.See study design
What are the potential side effects?
Potential side effects from medications such as SGLT2 inhibitors may include urinary infections or dehydration; beta blockers can cause fatigue or dizziness; ARNIs might lead to kidney problems or angioedema; MRAs could increase potassium levels which affects heart rhythm.
COPILOT-HF Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with heart failure.
COPILOT-HF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-months following randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-months following randomization
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Endpoint
Secondary outcome measures
Secondary Endpoint
Side effects data
From 2015 Phase 4 trial • 157 Patients • NCT020033916%
Ocular hyperaemia
5%
Eye pruritus
2%
Nasopharyngitis
2%
Dry eye
1%
Acute tonsillitis
1%
Pharyngitis
1%
Conjunctivitis allergic
1%
Eyelids pruritus
1%
Blepharal pigmentation
1%
Eye irritation
1%
Cataract
1%
Arthritis
1%
Hypersensitivity
1%
Eye pain
1%
Ocular surface disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
DuoTrav
Beta-blocker
COPILOT-HF Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Medication & Education-FirstExperimental Treatment1 Intervention
Patient will immediately begin participation in a remote, pharmacist-driven heart failure clinic that will initiate and titrate medications according to a standardized medical algorithm.
Group II: Education-FirstActive Control2 Interventions
Patient will first receive curated patient education, an alert to providers, and provider education, and then after 3 months begin participation in the remote heart failure clinic.
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Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,616 Previous Clinical Trials
11,470,448 Total Patients Enrolled
40 Trials studying Heart Failure
98,781 Patients Enrolled for Heart Failure
Boehringer IngelheimIndustry Sponsor
2,507 Previous Clinical Trials
11,340,407 Total Patients Enrolled
25 Trials studying Heart Failure
119,628 Patients Enrolled for Heart Failure
Eli Lilly and CompanyIndustry Sponsor
2,620 Previous Clinical Trials
3,216,099 Total Patients Enrolled
13 Trials studying Heart Failure
19,937 Patients Enrolled for Heart Failure
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function is severely reduced.You are receiving care for a terminal illness or are in hospice.I speak English or Spanish.I have a severe narrowing or leakage of the aortic valve in my heart.My heart pumps well and I am either on SGLT2 inhibitors or cannot tolerate them.Your heart function was checked in the last 24 months.I have been diagnosed with amyloidosis affecting my heart.I am currently undergoing chemotherapy.I have been diagnosed with heart failure.Your last measured blood pressure was lower than 90 mmHg.You are currently using a ventricular assist device.I have had a transplant or am being considered for one.I am on medication for Group 1 pulmonary arterial hypertension.My heart's pumping ability is below 50%, and I can't tolerate heart failure medications ARNi and SGLT2i.I am receiving heart medication through an IV at home.
Research Study Groups:
This trial has the following groups:- Group 1: Medication & Education-First
- Group 2: Education-First
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How hazardous is embracing the Medication & Education-First approach?
"Due to being a Phase 4 trial and thus having approval, the safety of Medication & Education-First is rated at 3 on our team's scale."
Answered by AI
Is it feasible to sign up for this clinical experiment at the present time?
"Data sourced from clinicaltrials.gov reveals that this trial is presently enrolling participants. The listed began on May 5th, 2023 and was last revised a fortnight later, on the 19th of the same month."
Answered by AI
Is senior participation permissible in this research endeavor?
"Participants that meet the criteria to be included in this trial must fall between 18-90 years of age. Notably, there are 22 trials for individuals under 18 and 726 targeting those over 65."
Answered by AI
How many individuals have signed up for the experiment thus far?
"Affirmative. According to clinicaltrials.gov, this study is presently searching for test subjects and was first posted on May 5th 2023 with the last update occurring two weeks later on May 19th 2023. 500 patients are being sought from a single trial site."
Answered by AI
May I partake in this clinical exploration?
"In total, 500 individuals with heart failure aged 18-90 have been enlisted in this research. Involved patients must be able to communicate either English or Spanish and are required to provide evidence of their condition (e.g., ICD-9 codes 428 ICD-10 codes I50). Additionally, they must have had an EF assessment within the past two years while having visited a Mass General Brigham provider for any reason during that same period of time."
Answered by AI
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