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HCMR - Novel Markers of Prognosis in Hypertrophic Cardiomyopathy
NCT01915615 · View on ClinicalTrials.gov ↗
Study Summary
Hypertrophic cardiomyopathy (HCM) is the most common monogenic heart disease and the most frequent cause of sudden cardiac death (SCD) in the young. It is characterized by unexplained left ventricular hypertrophy (LVH), diffuse and patchy fibrosis, and myofibrillar disarray. While the majority of patients remain asymptomatic, prognosis is poor in a subset who present with SCD or progress to heart failure (HF). Current methods to predict risk of these adverse events and to target therapy are limited. Current medical therapy does not protect against SCD, nor does it prevent development of HF. Therefore, the identification of novel risk markers would help develop therapeutic targets aimed at altering the phenotypic expression to impact the natural history, especially SCD and HF. Cardiovascular magnetic resonance (CMR) is emerging as a powerful tool for diagnosis and risk stratification in HCM including assessment of LV mass and pattern of hypertrophy. Late gadolinium enhancement by CMR is a marker of focal myocardial fibrosis which is thought to underlie the arrhythmogenic substrate as well as promote development of HF. The investigators hypothesize that HCM patients with a higher primary outcome event rate can be identified by novel CMR findings. The majority of cases of HCM are autosomal dominant and about 60% are caused by mutations in genes encoding cardiac sarcomeric proteins. However, the relationship between genetic mutation, disease phenotype, and clinical outcomes remains poorly understood. The investigators hypothesize that HCM patients with sarcomeric HCM mutations will have a higher primary outcome event rate and more marked myocardial pathology on CMR than those without. Furthermore, there may be a link between sarcomeric mutations and fibrosis, as mutation carriers with overt HCM as well as those without hypertrophy have elevated markers of collagen turnover. The investigators therefore hypothesize that serum biomarkers of collagen metabolism in HCM will
Conditions Studied
Interventions
- OTHER None - this is an observational study
Study Locations (20)
Massachusetts
- Tufts Medical Center — Boston
- Brigham & Women's Hospital — Boston
- Beth Israel Deaconess Medical Center — Boston
New York
- NYU Medical Center — New York
- St. Luke's Roosevelt University Hospital of Columbia University — New York
- Weill Cornell - New York Presbyterian — New York
Connecticut
- Yale University — New Haven
Illinois
- Northwestern University Feinberg School of Medicine — Chicago
Maryland
- Johns Hopkins University — Baltimore
Michigan
- University of Michigan Health System — Ann Arbor
Minnesota
- Mayo Clinic — Rochester
North Carolina
- Duke University Medical Center — Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,750 participants |
| Start Date | 2014-04 |
| Est. Completion | 2025-06 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01915615
The ClinicalTrials.gov registry entry for NCT01915615 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,750 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Virginia, which has 392 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Hypertrophic Cardiomyopathy appearing as the primary indexed condition, and to 1 intervention — of which None - this is an observational study is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01915615 reports 20 study locations spanning 16 distinct geographic areas — top geographies include Massachusetts, New York, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01915615 about?
NCT01915615 is a clinical study titled "HCMR - Novel Markers of Prognosis in Hypertrophic Cardiomyopathy". Hypertrophic cardiomyopathy (HCM) is the most common monogenic heart disease and the most frequent cause of sudden cardiac death (SCD) in the young. It is characterized by unexplained left ventricular hypertrophy (LVH), diffuse and patchy fibrosis, and myofibrillar disarray. While the majority of pa...
What is the current status of trial NCT01915615?
This trial is currently active not recruiting. The enrollment target is 2,750 participants. The study started on 2014-04. Estimated completion is 2025-06.
What conditions does trial NCT01915615 study?
This clinical trial studies the following conditions: Hypertrophic Cardiomyopathy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01915615?
The interventions under investigation include: None - this is an observational study (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01915615?
This trial is sponsored by University of Virginia, which has 392 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01915615 being conducted?
This trial has 20 study locations across Connecticut, Illinois, Maryland, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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