Finding Early Predictors of Myocardial Dysfunction
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Cross-Sectional
|Official Title:||Finding Early Predictors of Myocardial Dysfunction in Patients With Hypertension - Pilot Study.|
- Number of patients with changes in echocardiography during exercise [ Time Frame: 1 year ] [ Designated as safety issue: No ]Echocardiography at rest and during submaxinal exercise on a bicycle ergometer
- Changes in biomarkers levels according to clinical symptoms and echocardiography results [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
|Study Start Date:||October 2012|
|Study Completion Date:||March 2014|
|Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
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
The study is to allow for identification of patients with hypertension, in whom an early introduction of pharmacological treatment of heart failure HF should be considered. Evaluation in the detection of asymptomatic myocardial dysfunction will include potential heart failure markers such as: cardiotrophin 1, cystatin C, serum syndecan-4, collagen III N-terminal propeptide [PIIINP], NT-proBNP, IL1RL1 and modern echocardiography methods in order to increase the effectiveness of prevention, diagnosis and treatment optimalization.
Material and study plan about 100 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: Group A- 15 patients without symptoms of heart failure Group B- 30 patients with exertional dyspnoea Group C - 40 patients with overt heart failure
In group B (patients with exertional dyspnea/stenocardia) we will include only patients who have undergone CT coronary angiography without any identified changes in the epicardial coronary arteries, which will facilitate answering the presented purpose of research. Patients in groups A and B with normal resting echocardiography and treated with a maximum of 2 antihypertensive drugs (an ACE inhibitor or a sartan as therapy base), according to the following regimen:
ACEI/ARB + diuretic ACEI/ARB + calcium channel antagonist Group C - treatment in accordance with the standards for heart failure. Each patient will be informed about the objectives of the study and give written consent to participate.
After signing informed consent patients will have performed the following tests:
- Interview and documentation analysis,
- Physical examination,
- Echocardiography at rest and during submaximal exercise on a bicycle ergometer
- Levels of markers: cystatin C, cardiotrophin-1, Procollagen III N-Terminal Propeptide (PIIINP), Syndecan 4 (SDC4) and NT-proBNP, IL1RL1. Each patient will be informed about the objectives of the study and give written consent to participate.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02026154
|Department of Hypertension, Medical University of Lodz|
|Principal Investigator:||Agata Bielecka-Dabrowa, PhD||Medical University of Lodz|