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Differentiating Hypertrophic Cardiomyopathy From Hypertensive Heart Disease

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ClinicalTrials.gov Identifier: NCT03271385
Recruitment Status : Recruiting
First Posted : September 5, 2017
Last Update Posted : November 13, 2017
Sponsor:
Collaborators:
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Ruijin Hospital
LanZhou University
Kunming Medical University
Beijing Anzhen Hospital
West China Hospital
Information provided by (Responsible Party):
RenJi Hospital

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.


Condition or disease Intervention/treatment
Hypertrophic Cardiomyopathy Hypertensive Heart Disease 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.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Differentiating Hypertrophic Cardiomyopathy From Hypertensive Heart Disease: a Multi-center, Prospective, Controlled Clinical Trial
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : July 1, 2020


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.




Primary Outcome Measures :
  1. validation of the algorithm in all patients [ Time Frame: after post-procession and complete the flow chart within 24 hours ]
    Evaluate the area under the curve of our algorithm compared with single parameter (wall thickness, strain) in all patients


Secondary Outcome Measures :
  1. validation of the algorithm in subgroup patients [ Time Frame: after post-procession and complete the flow chart within 24 hours ]
    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-)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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 >81 g/m2 (Male) or >61 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03271385


Contacts
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Contact: Meng Jiang, MD 13788912766 ext 58752445 jiangmeng0919@163.com
Contact: Xiaoying Ying, MD 18621517838 ext 58752445 akoma78@hotmail.com

Locations
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China
Renji Hospital Recruiting
Shanghai, China, 200127
Contact: Zi Wang, postgraduate       wangziz10@126.com   
Contact: Xuan Su, postgraduate       18817560226@163.com   
Sponsors and Collaborators
RenJi Hospital
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Ruijin Hospital
LanZhou University
Kunming Medical University
Beijing Anzhen Hospital
West China Hospital
Investigators
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Study Chair: Meng Jiang, MD RenJi Hospital, School of Medicine, Shanghai Jiaotong University
Study Director: Lianming Wu, MD RenJi Hospital, School of Medicine, Shanghai Jiaotong University

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Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT03271385     History of Changes
Other Study ID Numbers: 20170406J
First Posted: September 5, 2017    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by RenJi Hospital:
hypertrophic Cardiomyopathy
hypertensive Heart Disease
cardiac magnetic resonance
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Hypertrophic
Heart Diseases
Hypertension
Hypertrophy
Cardiovascular Diseases
Vascular Diseases
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases