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NCT01915615 · ClinicalTrials.gov registry record

HCMR - Novel Markers of Prognosis in Hypertrophic Cardiomyopathy

A clinical trial of Hypertrophic Cardiomyopathy, sponsored by University of Virginia.

Active
Registry status
2,750
Enrollment target
20
Study locations

NCT01915615 is a study of Hypertrophic Cardiomyopathy that is active but no longer recruiting, run by University of Virginia. The registered enrollment target is 2,750 participants, above the 1,076-participant average among 10 other Hypertrophic Cardiomyopathy trials with a reported enrollment target (156% higher). The trial reports 20 study locations across 16 states.

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The verdict

NCT01915615, a study of Hypertrophic Cardiomyopathy, is active but no longer recruiting, sponsored by University of Virginia.

ACTIVE NOT RECRUITING
Registry status
2,750 participants
Enrollment target
20
Study locations

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

Hypertrophic Cardiomyopathy

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

FieldValue
Enrollment Target 2,750 participants
Start Date 2014-04
Est. Completion 2025-06

Sponsor

University of Virginia

449 total trials

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What the Registry Record Tells You About NCT01915615

The ClinicalTrials.gov registry entry for NCT01915615 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 2,750 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 1,076-participant average among 10 other Hypertrophic Cardiomyopathy trials with a reported enrollment target (156% higher). The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.

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.

NCT01915615 reports 20 study locations spanning 16 distinct geographic areas - top geographies include Massachusetts, New York, Connecticut.

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.

What interventions are being tested in trial NCT01915615?

The interventions under investigation include: None - this is an observational study (OTHER).

Who is sponsoring clinical trial NCT01915615?

This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.