Clinical trial NCT02026154: Finding Early Predictors of Myocardial Dysfunction
Official title: Finding Early Predictors of Myocardial Dysfunction in Patients With Hypertension - Pilot Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Heart Failure
Keywords: hypertension, biomarkers, echocardiography, heart failure
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
First posted: 2014-01-01
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 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

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.

Detailed description: 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,
* Electrocardiogram
* 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.

Eligibility criteria: Inclusion 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

Exclusion Criteria:

* 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
* with cardiomyopathies (A,B)
* with cancer
* with anemia
* abusing alcohol or drugs
* with chronic inflammatory and other diseases
* or who have not given their informed consent to participate in the study

Primary outcomes:
measure: Number of patients with changes in echocardiography during exercise
timeFrame: 1 year
Secondary outcomes:
measure: Changes in biomarkers levels according to clinical symptoms and echocardiography results
timeFrame: 1 year
Other outcomes:
Locations:
city: Lodz
country: Poland
facility: Department of Hypertension, Medical University of Lodz
Study officials:
affiliation: Medical University of Lodz
name: Agata Bielecka-Dabrowa, PhD
role: PRINCIPAL_INVESTIGATOR
References: