Differentiation HHD From HCM (EARLY-MYO-HHD)

NCT ID: NCT03271385

Last Updated: 2022-11-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 465 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2021-12-31

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.

Detailed Description

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.

Conditions

Hypertrophic Cardiomyopathy; Hypertensive Heart Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

evaluated by the predetermined differentiating formula

Intervention Type: 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.

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.

evaluated by the predetermined differentiating formula

Intervention Type: 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

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.

evaluated by the predetermined differentiating formula

Intervention Type: 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.

Interventions

evaluated by the predetermined differentiating formula

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Control group: (1) Absence of known systemic diseases; (2)Normal examinations（normal findings in both echocardiography and CMR）.

2. 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.

3. 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

1. Documented coronary artery disease: previous history or CAG>50%;

2. NYHA Ⅳ level;

3. Severe aortic valve stenosis;

4. Standard metallic contraindications to CMR;

5. Systemic diseases or Infiltrative cardiomyopathy;

6. Septal ablation for drug-refractory hypertrophic obstructive cardiomyopathy.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

OTHER

Sponsor Role: collaborator

Ruijin Hospital

OTHER

Sponsor Role: collaborator

LanZhou University

OTHER

Sponsor Role: collaborator

Kunming Medical University

OTHER

Sponsor Role: collaborator

Beijing Anzhen Hospital

OTHER

Sponsor Role: collaborator

West China Hospital

OTHER

Sponsor Role: collaborator

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Meng Jiang, MD

Role: STUDY_CHAIR

RenJi Hospital, School of Medicine, Shanghai Jiaotong University

Lianming Wu, MD

Role: STUDY_DIRECTOR

RenJi Hospital, School of Medicine, Shanghai Jiaotong University

Locations

Renji Hospital

Shanghai, , China

Countries

China

Other Identifiers

20170406J

Identifier Type: -

Identifier Source: org_study_id