Finding Early Predictors of Myocardial Dysfunction

Sponsor

Medical University of Lodz (Other)

Overall Status

Completed

CT.gov ID

NCT02026154

Collaborator

(none)

120

Enrollment

Location

Duration (Months)

7.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension Heart Failure

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.

Study Design

Study Type:

Observational

Actual Enrollment :

120 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Finding Early Predictors of Myocardial Dysfunction in Patients With Hypertension - Pilot Study.

Study Start Date :

Oct 1, 2012

Actual Primary Completion Date :

Feb 1, 2014

Actual Study Completion Date :

Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Number of patients with changes in echocardiography during exercise [1 year]
Echocardiography at rest and during submaxinal exercise on a bicycle ergometer

Secondary Outcome Measures

Changes in biomarkers levels according to clinical symptoms and echocardiography results [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Hypertension, Medical University of Lodz	Lodz		Poland

Sponsors and Collaborators

Medical University of Lodz

Investigators

Principal Investigator: Agata Bielecka-Dabrowa, PhD, Medical University of Lodz

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Agata Bielecka-Dabrowa, MD, PhD, Department of Hypertension, MD, PhD, FESC, cardiologist, Medical University of Lodz

ClinicalTrials.gov Identifier:

NCT02026154

Other Study ID Numbers:

RNN/749/13/KB
grant for young scientist 2012

First Posted:

Jan 1, 2014

Last Update Posted:

May 6, 2014

Last Verified:

May 1, 2014

Keywords provided by Agata Bielecka-Dabrowa, MD, PhD, Department of Hypertension, MD, PhD, FESC, cardiologist, Medical University of Lodz

hypertension, biomarkers, echocardiography, heart failure

Additional relevant MeSH terms:

Hypertension

Heart Failure

Study Results

No Results Posted as of May 6, 2014