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Differentiation HHD From HCM (EARLY-MYO-HHD)

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03271385
Enrollment
465
Registered
2017-09-05
Start date
2017-07-01
Completion date
2021-12-31
Last updated
2022-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertensive Heart Disease, Hypertrophic Cardiomyopathy

Keywords

hypertrophic Cardiomyopathy, hypertensive Heart Disease, cardiac magnetic resonance

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.

Interventions

DIAGNOSTIC_TESTevaluated 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.

Sponsors

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

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
validation of the algorithm in all patientsafter post-procession and complete the flow chart within 24 hoursEvaluate the area under the curve of our algorithm compared with single parameter (wall thickness, strain) in all patients

Secondary

MeasureTime frameDescription
validation of the algorithm in subgroup patientsafter post-procession and complete the flow chart within 24 hoursEvaluate 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-)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026