Finding Early Predictors of Myocardial Dysfunction
2 other identifiers
observational
120
1 country
1
Brief Summary
The study objective is to clarify the grounds of heart exertional dyspnoea stenocardia in patients with well-controlled stage I or II hypertension according to European Society of Hypertension, without changes in epicardial coronary arteries in CT coronary angiography and normal resting echocardiography result, and to assess of potential early markers of heart hypertrophy and failure in patients with hypertension.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 31, 2013
CompletedFirst Posted
Study publicly available on registry
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedMay 6, 2014
May 1, 2014
1.3 years
December 31, 2013
May 5, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients with changes in echocardiography during exercise
Echocardiography at rest and during submaxinal exercise on a bicycle ergometer
1 year
Secondary Outcomes (1)
Changes in biomarkers levels according to clinical symptoms and echocardiography results
1 year
Study Arms (1)
A, B, C
Group A- 15 patients without symptoms of heart failure - control group Group B- 30 patients with exertional dyspnoea Group C - 40 patients with overt heart failure
Eligibility Criteria
persons (age 30-70 years old) will be included in the study, patients with stage I or II primary hypertension according to the European Society of Hypertension
You may qualify if:
- persons (age 30-70 years old) will be included in the study, patients with stage I or II primary hypertension according to the European Society of Hypertension
You may not qualify if:
- with coronary artery disease or a history of coronary artery disease (A, B)
- with unstable hypertension
- with a positive stress test
- with NYHA class III-IV heart failure
- after percutaneous or surgical revascularization
- with diabetes
- with GFR \< 60
- with hyperthyroidism and hypothyroidism
- active smokers
- with an implanted pacemaker
- with obesity level II and III
- with ECG-arrhythmia
- pregnant and lactating
- with congenital heart disease
- with hemodynamically significant acquired heart defects
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Hypertension, Medical University of Lodz
Lodz, Poland
Biospecimen
blood plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Agata Bielecka-Dabrowa, PhD
Medical University of Lodz
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD, FESC, cardiologist
Study Record Dates
First Submitted
December 31, 2013
First Posted
January 1, 2014
Study Start
October 1, 2012
Primary Completion
February 1, 2014
Study Completion
March 1, 2014
Last Updated
May 6, 2014
Record last verified: 2014-05