Clinical trial NCT03271385: Differentiation HHD From HCM (EARLY-MYO-HHD)
Official title: EARLY Differentiation of MYOcardial Hypertrophy Between Hypertensive Heart Disease and Hypertrophic Cardiomyopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertrophic Cardiomyopathy
Hypertensive Heart Disease
Keywords: hypertrophic Cardiomyopathy
hypertensive Heart Disease
cardiac magnetic resonance
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: Ruijin Hospital
name: LanZhou University
name: Kunming Medical University
name: Beijing Anzhen Hospital
name: West China Hospital
First posted: 2017-09-05
Enrollment: 465
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

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.

Primary outcomes:
measure: validation of the algorithm in all patients
timeFrame: after post-procession and complete the flow chart within 24 hours
Secondary outcomes:
measure: validation of the algorithm in subgroup patients
timeFrame: after post-procession and complete the flow chart within 24 hours
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
Study officials:
affiliation: RenJi Hospital, School of Medicine, Shanghai Jiaotong University
name: Meng Jiang, MD
role: STUDY_CHAIR
affiliation: RenJi Hospital, School of Medicine, Shanghai Jiaotong University
name: Lianming Wu, MD
role: STUDY_DIRECTOR
References: