An observational study in Hypertension and Heart Failure, sponsored by Medical University of Lodz. Completed at 1 site in Poland. Open to participants aged 30 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-05-06.
Sponsored by Medical University of Lodz · Observational
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.
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:
6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.
This study's enrollment of 120 is below the median of 210 across 1,392 observational studies indexed under Hypertension.
Browse Hypertension studies →Medical University of Lodz is the lead sponsor of 104 studies on the registry; 9 are open to participants now.
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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
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Exclusion Criteria:
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
Number of patients with changes in echocardiography during exercise
Echocardiography at rest and during submaxinal exercise on a bicycle ergometer
Time frame: 1 year
Changes in biomarkers levels according to clinical symptoms and echocardiography results
Time frame: 1 year
The record gives a start of Oct 2012, a primary completion of Feb 2014 and a completion of Mar 2014. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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