Differentiation HHD From HCM (EARLY-MYO-HHD)

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertrophic Cardiomyopathy; Hypertensive Heart Disease
• Intervention / Treatment: Diagnostic test: evaluated by the predetermined differentiating formula

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.

• Study Type: Observational
• Enrollment (Actual): 465

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200127
    • Renji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.	Diagnostic test: 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
validation of the algorithm in subgroup patients	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-)	after post-procession and complete the flow chart within 24 hours

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Collaborators: LanZhou University; West China Hospital; Ruijin Hospital; Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University; Beijing Anzhen Hospital; Kunming Medical University
• Investigators: Study Director: Lianming Wu, MD, Renji Hospital, School of Medicine, Shanghai Jiaotong University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: August 21, 2017
• First Submitted That Met QC Criteria: August 31, 2017
• First Posted (Actual): September 5, 2017

Study Record Updates

• Last Update Posted (Actual): November 17, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: cardiac magnetic resonance; hypertrophic Cardiomyopathy; hypertensive Heart Disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Heart Diseases; Hypertension; Hypertrophy; Cardiomyopathies; Cardiomyopathy, Hypertrophic
• Other Study ID Numbers: 20170406J

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No