Finding Early Predictors of Myocardial Dysfunction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Agata Bielecka-Dabrowa, MD, PhD, Department of Hypertension, Medical Universtity of Lodz
ClinicalTrials.gov Identifier:
NCT02026154
First received: December 31, 2013
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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
Hypertension
Heart Failure

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Finding Early Predictors of Myocardial Dysfunction in Patients With Hypertension - Pilot Study.

Resource links provided by NLM:


Further study details as provided by Medical Universtity of Lodz:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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

blood plasma


Enrollment: 120
Study Start Date: October 2012
Study Completion Date: March 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02026154

Locations
Poland
Department of Hypertension, Medical University of Lodz
Lodz, Poland
Sponsors and Collaborators
Medical Universtity of Lodz
Investigators
Principal Investigator: Agata Bielecka-Dabrowa, PhD Medical University of Lodz
  More Information

No publications provided

Responsible Party: Agata Bielecka-Dabrowa, MD, PhD, Department of Hypertension, MD, PhD, FESC, cardiologist, Medical Universtity of Lodz
ClinicalTrials.gov Identifier: NCT02026154     History of Changes
Other Study ID Numbers: RNN/749/13/KB, grant for young scientist 2012
Study First Received: December 31, 2013
Last Updated: May 5, 2014
Health Authority: Poland: Ethics Committee

Keywords provided by Medical Universtity of Lodz:
hypertension, biomarkers, echocardiography, heart failure

Additional relevant MeSH terms:
Heart Failure
Hypertension
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014