Epidemic Profile of Left Ventricular Diastoic Dysfunction in the Community Elderly and Establishing Prediction Model: the Northern Shanghai Study (ELITISM)

This study is one of the largest ongoing prospective population studies to evaluate target organ damages (TODs) and Left Ventricular Diastoic Dysfunction in the community-dwelling elderly Chinese, which is authorised and funded by the Shanghai municipal government.This study was approved by the Shanghai Tenth People's Hospital Institutional Review Board and was conducted under financial support from the Shanghai municipal government (grant ID: 2013ZYJB0902 and 15GWZK1002). The preliminary sample size is expected to be 3000-4000 participants.

Study Overview

• Status: Completed
• Conditions: Left Ventricular Diastoic Dysfunction Cohort Study
• Intervention / Treatment: Other: Diuretic，Betaloc，antiplatelet drugs

Detailed Description

The Northern Shanghai Study is an ongoing prospective community-based study. After enrolment, clinical examination,anthropometric measurement and a questionnaire will be administered to each participant at baseline and patients will be followed up every six months. Our tests and examinations include: blood/urine sample and biochemical measurements, office blood pressure recording, carotid ultrasonograph, echocardiograph, pulse wave velocity, pulse wave analysis, 4-limb blood pressure recording, body mass index, etc. Baseline measurement will also include the assessments on target organ damages(TODs) and the conventional CV risk factors. In the follow-up, the incidence of CV events and mortality will be recorded. The Northern Shanghai Risk Score will be calculated, with considerations on CV risk factors and TODs.

• Study Type: Observational
• Enrollment (Actual): 1920

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Northern Shanghai region has the largest population of elderly adults in Shanghai, with a total population of 1.57 million and an elderly proportion of over 19%. We use a computer-generated list of communities, and 10 communities were randomly selected for the first-phase enrolment. Other communities in the list will be randomly selected for the later enrolment. According to the inclusion and exclusion criteria, we invite all the eligible older people (over 55 years) to participate in this study. The recruitment strategies include: (1) posting study recruitment files in the neighbourhood committees and community hospitals; (2) according to the health file, community hospitals recruit the potential participants Open Accessby telephone; (3) hand out recruitment flyers directly to the potential participants.

Description

Inclusion Criteria:

1. age 55 years or more
2. informed consent should be signed voluntarily
3. local residents from communities in northern Shanghai and available for long-term follow-up

Exclusion Criteria:

1. was diagnosed with serious heart disease (NYHA≥IV) or end-stage renal disease (CKD ≥4 stage)
2. suffered from cancer or his/her life expectancy is <5 years
3. had stroke within 3 months
4. is not willing to participate in the clinical study
5. has to quit the trial due to other diseases
6. violates the protocol or loses contact with the laboratory staff.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Left Ventricular Diastoic Dysfunction Classification; normal diastole pattern：E/A>1，DT 160~220 ms，S/D >1，AR 0.22-0.32m/sec，E/e'< 8 diastolic dysfunction pattern Impaired relaxation pattern：E/A< 1，DT > 220 ms，S/D > 1，AR 0.21-0.28 m/sec，E/e'<10 Pseudo-normalization pattern：E/A> 1，DT 150~210 ms，S/D < 1，AR ≥0.35m/sec，E/e'≥ 10 Restrictive pattern：E/A ≥ 2，DT < 150 ms，S/D <1，AR ≥0.25m/sec，E/e'≥10	Other: Diuretic，Betaloc，antiplatelet drugs; According to international guidelines,we treated patinets who suffered from different disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
left ventricular diastolic dysfunction	All the ultrasonography measurements are performed with a MyLab 30 CV machine (ESAOTE SpA, Genoa, Italy), according to the American Society of Echocardiography (ASE) recommendations.The echocardiography is performed in the left decubitus position. Left ventricular (LV) internal diameter at end-diastole (LVIDd) and septal (SWTd) and posterior wall thickness at end-diastole (PWTd) are measured directly. left ventricular diastolic dysfunction including: Impaired relaxation pattern：E/A< 1，DT > 220 ms，S/D > 1，AR 0.21-0.28 m/sec，E/e'<10 Pseudo-normalization pattern：E/A> 1，DT 150~210 ms，S/D < 1，AR ≥0.35m/sec，E/e'≥ 10 Restrictive pattern：E/A ≥ 2，DT < 150 ms，S/D <1，AR ≥0.25m/sec，E/e'≥10	From July 2014 to August 2019

Collaborators and Investigators

• Sponsor: Ya-Wei Xu

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2014
• Primary Completion (Actual): July 10, 2014
• Study Completion (Actual): August 10, 2014

Study Registration Dates

• First Submitted: November 7, 2018
• First Submitted That Met QC Criteria: November 7, 2018
• First Posted (Actual): November 8, 2018

Study Record Updates

• Last Update Posted (Actual): April 26, 2021
• Last Update Submitted That Met QC Criteria: April 22, 2021
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Left Ventricular Diastoic Dysfunction Cohort study
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Natriuretic Agents; Sympatholytics; Adrenergic beta-1 Receptor Antagonists; Metoprolol; Diuretics; Platelet Aggregation Inhibitors
• Other Study ID Numbers: ELITISM

Drug and device information, study documents

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