A Longitudinal Observational Study of Self-reported Cardiomyopathy in the Heart Hive
Heart Hive Study: Tracking Cardiomyopathy and Myocarditis
Plain English Summary
The Heart Hive - Cardiomyopathy Study is a Not Applicable clinical trial sponsored by Imperial College London studying Cardiomyopathies, Myocarditis. This study tracks patients with heart muscle conditions like cardiomyopathy and myocarditis. It's for adults (18+) diagnosed with these conditions or with a family history. Participation involves joining an online registry and database, with optional genetic testing. There are no alternative treatments offered within this study; it is purely observational. The trial aims to enroll 10000 participants.
Official Summary
This is an online registry and database of patients with cardiomyopathy and myocarditis, coupled with an observational study of cardiomyopathies.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 and over can join. You must have a confirmed diagnosis of cardiomyopathy or myocarditis, or a family history of these conditions. You must be able to give informed consent. People with severe, uncontrolled high blood pressure, or a history of coronary artery disease, valvular heart disease, or congenital heart disease cannot join. This trial is studying Cardiomyopathies, Myocarditis, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The study will track how many participants experience death from heart-related causes, irregular heartbeats, or major heart failure events over a long period, providing insights into the long-term imp The specific primary outcome measures are: Number of participants with cardiovascular cause of death (90 years); Number of participants with arrhythmic events (90 years); Number of participants with major heart failure events (90 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This study aims to build a comprehensive understanding of cardiomyopathies, a group of diseases that affect the heart muscle, helping to fill a gap in knowledge for these conditions. This research targets Cardiomyopathies, Myocarditis, where improved treatment options are needed.
Investor Insight
This observational study by a leading academic institution aims to gather extensive data on cardiomyopathies, potentially informing future research and treatment development in a significant patient p The large enrollment target of 10000 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor if this study is right for you and how it differs from your regular care. Participation involves joining an online registry and may include optional genetic testing using a saliva sample. The study is observational and does not interfere with your current medical treatment. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 10,000 participants
Interventions
- GENETIC: Research genetic analysis — Genetic analysis of DNA extracted from saliva. Participants can opt in to receive individual results of research genetic analysis for a predefined panel of clinically actionable cardiomyopathy genes.
Primary Outcomes
- Number of participants with cardiovascular cause of death (90 years)
- Number of participants with arrhythmic events (90 years)
- Number of participants with major heart failure events (90 years)
Full Eligibility Criteria
Inclusion Criteria: * Adult (age 18 and over), * Males and Females, * Capacity to provide informed consent, * Patients with a confirmed diagnosis of cardiomyopathy or myocarditis, * People with a family history of cardiomyopathy confirmed in a first or second degree relative. Note: Pregnant women are eligible. This study is observational and entirely separate from clinical care. Exclusion criteria: * Patients who lack capacity to consent for themselves, * Vulnerable groups (e.g. those under 18, prisoners, those in a dependent relationship, the mentally ill). * Patients with a confirmed history of coronary artery disease: * who have been informed by their treating physician that their cardiomyopathy is secondary to their coronary artery disease, or * who have undergone previous percutaneous coronary intervention or coronary bypass surgery * History of primary valvular heart disease or congenital heart disease * Severe, untreated or untreatable hypertension (systolic blood pressures routinely \>180 mm Hg and/or diastolic blood pressures \>120 mm Hg)
Trial Locations
- Imperial College London, London, United Kingdom
Frequently Asked Questions
What is clinical trial NCT04612296?
NCT04612296 is a Not Applicable OBSERVATIONAL study titled "The Heart Hive - Cardiomyopathy Study." It is currently recruiting and is sponsored by Imperial College London. The trial targets enrollment of 10000 participants.
What conditions does NCT04612296 study?
This trial investigates treatments for Cardiomyopathies, Myocarditis. The primary condition under study is Cardiomyopathies.
What treatments are being tested in NCT04612296?
The interventions being studied include: Research genetic analysis (GENETIC). Genetic analysis of DNA extracted from saliva. Participants can opt in to receive individual results of research genetic analysis for a predefined panel of clinically actionable cardiomyopathy genes.
What does Not Applicable mean for NCT04612296?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT04612296?
This trial is currently "Recruiting." It started on 2019-11-09. The estimated completion date is 2027-09.
Who is sponsoring NCT04612296?
NCT04612296 is sponsored by Imperial College London. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT04612296?
The trial aims to enroll 10000 participants. The trial is currently recruiting and accepting new participants.
How is NCT04612296 designed?
This is a observational study.
What are the primary outcomes being measured in NCT04612296?
The primary outcome measures are: Number of participants with cardiovascular cause of death (90 years); Number of participants with arrhythmic events (90 years); Number of participants with major heart failure events (90 years). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT04612296 being conducted?
This trial is being conducted at 1 site, including London (United Kingdom).
Where can I find official information about NCT04612296?
The official record for NCT04612296 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT04612296. This government database provides the most up-to-date and detailed information about the trial.
What is NCT04612296 testing in simple terms?
This study tracks patients with heart muscle conditions like cardiomyopathy and myocarditis. It's for adults (18+) diagnosed with these conditions or with a family history.
Why is this trial significant?
This study aims to build a comprehensive understanding of cardiomyopathies, a group of diseases that affect the heart muscle, helping to fill a gap in knowledge for these conditions.
What are the potential risks of participating in NCT04612296?
The primary risks are related to the optional genetic testing, which may reveal information about your health or family's health. There are no direct physical risks as this is an observational study separate from clinical care. Potential psychological distress from receiving genetic results or learning about disease progression. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT04612296?
Ask your doctor if this study is right for you and how it differs from your regular care. Participation involves joining an online registry and may include optional genetic testing using a saliva sample. The study is observational and does not interfere with your current medical treatment. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT04612296 signal from an investment perspective?
This observational study by a leading academic institution aims to gather extensive data on cardiomyopathies, potentially informing future research and treatment development in a significant patient p This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves joining an online registry and database, with optional genetic testing. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.