Differentiation HHD From HCM (EARLY-MYO-HHD)

Hypertrophic Cardiomyopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03271385
• Other study ID #: 20170406J
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: September 2021
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 465
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 ? 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.

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Heart Diseases
• Hypertension
• Hypertensive Heart Disease
• Hypertrophic Cardiomyopathy
• Hypertrophy

Intervention

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.

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai

Sponsors (7)

Lead Sponsor	Collaborator
RenJi Hospital	Beijing Anzhen Hospital, Kunming Medical University, LanZhou University, Ruijin Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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