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Completed

NCT Number: NCT03271385

Differentiation HHD From HCM (EARLY-MYO-HHD)

Differentiating hypertrophic cardiomyopathy (HCM) from hypertensive heart disease (HHD) unavoidably encounters diagnostic challenges especially in patient of suspected HCM with history of hypertension. Diverse and overlapping forms of HCM can often lead to ambiguity when diagnosis is based on a single genetic or morphological index.

The investigators have deduced a integrated formula based on cardiac magnetic resonance (CMR) imaging and established a differentiating flow-chart between HCM and HHD, the investigators aim to identify their method in the current multi-center trial.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Renji Hospital

Shanghai, 200127, China

About this study

Both hypertrophic cardiomyopathy (HCM) and hypertensive heart disease (HHD) present left ventricular hypertrophy (LVH), but the prognosis varies. Nevertheless, the feasibility of distinguishing these two conditions is limited by the fact that overlapping LVH and diverse forms of HCM can often lead to diagnostic ambiguity when diagnosis is based on a single morphological index. Diagnosis is more difficult in a patient with a history of hypertension and with left ventricular wall thickness between 11 and 15 mm. It also puzzles the situation when hypertrophy without outflow-track obstruction was found in hypertensive subjects which might not be explained solely by the history of hypertension.

The investigators have deduced an integrated formula based on cardiac magnetic resonance (CMR) imaging and established a differentiating flow-chart between HCM and HHD. In this study, the investigators aim to explore the applicability of the quantifying scheme for distinguishing HCM from HHD in the multi-center trial.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Control group: (1) Absence of known systemic diseases; (2)Normal examinations(normal findings in both echocardiography and CMR).
  • Hypertrophic cardiomyopathy: 1) genetic determination of a pathogenic mutation or 2) left ventricular hypertrophy (LVH) (end-diastolic wall thickness >15 mm) with resting left ventricular outflow tract obstruction or 3) hypertrophy in a recognizable pattern, i.e., ventricular bulge in apical-variant HCM; Of note, patients with documented HCM were divided into subgroups based on whether concomitant with hypertension or left ventricular outflow tract (LVOT) obstruction.
  • Hypertensive Heart Disease: (1) Long durations of uncontrolled hypertension (systolic blood pressure≥150 mm Hg or diastolic blood pressure ≥90 mm Hg); Echocardiography: left ventricular wall thickness in diastolic >11mm; Absence of other cardiac or systemic diseases; (2) left ventricular mass/body surface area >115 g/m2 (Male) or >95 g/m2 (Female).

Exclusion criteria

  • Documented coronary artery disease: previous history or CAG>50%;
  • NYHA Ⅳ level;
  • Severe aortic valve stenosis;
  • Standard metallic contraindications to CMR;
  • Systemic diseases or Infiltrative cardiomyopathy;
  • Septal ablation for drug-refractory hypertrophic obstructive cardiomyopathy.

Treatment and study plan

evaluated by the predetermined differentiating formula

Diagnostic Test

After recruiting patients, collecting the baseline data, a CMR scan will be carried out and post-processed, a predetermined differentiating formula (including left ventricular morphology, ejection fraction, presence of late gadolinium enhancement, T1 value and strain data) will be used to produce a cardiac values, which is to be input into our differentiating flow.

Primary outcomes

  1. validation of the algorithm in all patients

    Time frame: after post-procession and complete the flow chart within 24 hours

    Evaluate the area under the curve of our algorithm compared with single parameter (wall thickness, strain) in all patients

Secondary outcomes

  1. validation of the algorithm in subgroup patients

    Time frame: after post-procession and complete the flow chart within 24 hours

    Evaluate the area under the curve of our algorithm compared with single parameter (wall thickness, strain) in subgroup patients (HHD and HCM/HBP-; HHD and HCM/HBP+; HHD and HCM/OBSR-; HHD and HCM/HBP+/OBSR-)

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Collaborators

  • Beijing Anzhen Hospital
  • Kunming Medical University
  • LanZhou University
  • Ruijin Hospital
  • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
  • West China Hospital

Registry information

Official study title

EARLY Differentiation of MYOcardial Hypertrophy Between Hypertensive Heart Disease and Hypertrophic Cardiomyopathy

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Sep 5, 2017
Registry last updated
Nov 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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