Differentiation HHD From HCM (EARLY-MYO-HHD)

NCT03271385 | Completed DMC

• 1 other identifier: 20170406J
• Study Type: observational
• Target: 465
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertrophic Cardiomyopathy; Hypertensive Heart Disease

Keywords

hypertrophic Cardiomyopathy; hypertensive Heart Disease; cardiac magnetic resonance

Outcome Measures

Primary Outcomes (1)

• validation of the algorithm in all patients

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

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

Secondary Outcomes (1)

• validation of the algorithm in subgroup patients

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

Study Arms (3)

hypertrophic cardiomyopathy group

The hypertrophic cardiomyopathy was diagnosed by left ventricular hypertrophy via echocardiography (wall thickness \>15 mm) with either genetic determination of a pathogenic mutation or ) left ventricular hypertrophy (LVH) (end-diastolic wall thickness \>15 mm) with resting left ventricular outflow tract obstruction or hypertrophy in a recognisable pattern, i.e., ventricular bulge in apical-variant HCM. And then patients with hypertrophic cardiomyopathy were evaluated by the predetermined differentiating formula.

Diagnostic Test: evaluated by the predetermined differentiating formula

hypertensive heart disease group

The diagnosis of hypertensive heart disease was based on medical history and conventional echocardiography. Long durations of uncontrolled hypertension for at least 5 years with systolic blood pressure \[BP\] ≥150 mm Hg or diastolic BP ≥90 mm Hg or both in the absence of other cardiac or systemic diseases were used as criteria. And then patients with hypertensive heart disease were evaluated by the predetermined differentiating formula.

Diagnostic Test: evaluated by the predetermined differentiating formula

control group

The healthy age-matched controls were generally volunteers with a normal electrocardiogram, normal echocardiographic examination, and overall normal CMR findings. And then patients with normal findings were were evaluated by the predetermined differentiating formula.

Diagnostic Test: evaluated by the predetermined differentiating formula

Interventions

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.

control group; hypertensive heart disease group; hypertrophic cardiomyopathy group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive subjects were prospectively enrolled into 3 cohorts between July 2017 and June 2020. The cohorts were divided as follows: the hypertrophic cardiomyopathy, hypertensive heart disease and control groups

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Renji Hospital

Shanghai, 200127, China

Location

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Officials

• Meng Jiang, MD

  RenJi Hospital, School of Medicine, Shanghai Jiaotong University

  STUDY CHAIR

• Lianming Wu, MD

  RenJi Hospital, School of Medicine, Shanghai Jiaotong University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: September 5, 2017
• Study Start: July 1, 2017
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: November 17, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)