Finding Early Predictors of Myocardial Dysfunction in Patients With Hypertension

NCT01455714 | Unknown DMC

• 1 other identifier: RNN/446/10/KB
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Finding early predictors of myocardial in patients with hypertension

• Interview and documentation analysis,
• Physical examination,
• Electrocardiogram,
• 24-hour blood pressure monitoring (ABPM),
• 24-hour EKG recording,
• Echocardiography at rest and during submaxinal exercise on a bicycle ergometer,
• Flow-mediated dilatation (FMD),
• Cardiac magnetic resonance imaging,
• Standard labolatory parameters,
• Levels of markers: cystatin C, cardiotrophin-1, metaloproteinases: MMP-2, MMP-7, MMP-8, MMP-9, Procollagen III N-Terminal Propeptide (PIIINP), Syndecan 4 (SDC4) and NT-proBNP Each patient will be informed about the objectives of the study and give written consent to participate.

Conditions

Hypertension

Keywords

hypertenion; exertional dyspnoea; heart failure; biomarkers

Outcome Measures

Primary Outcomes (3)

• Changes in levels of biomarkers

  Levels of markers: cystatin C, cardiotrophin-1, metaloproteinases: MMP-2, MMP-7, MMP-8, MMP-9, Procollagen III N-Terminal Propeptide (PIIINP), Syndecan 4 (SDC4) and NT-proBNP

  two years

• echocardiographical parameters

  Echocardiography at rest and during submaxinal exercise on a bicycle ergometer

  two years

• assessment of perfusion and endothelium function

  * Flow-mediated dilatation (FMD), * Cardiac magnetic resonance imaging,

  two years

Secondary Outcomes (3)

• mortality

  two years

• exertional dyspnoea

  two years

• heart failure aggravation

  two years

Study Arms (1)

A, B, C

Group A- 40 patients without symptoms of heart failure Group B- 40 patients with exertional dyspnoea Group C - 40 patients with overt heart failure

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

120 persons (age 40-60 years old) will be included in the study, patients with stage I or II primary hypertension according to the European Society of Hypertension

You may qualify if:

• persons (age 40-60 years old) will be included in the study, patients with stage I or II primary hypertension according to the European Society of Hypertension

You may not qualify if:

• Following patients will be excluded from the study:
• with coronary artery disease or a history of coronary artery disease
• 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 hip, knee endoprosthesis
• with claustrophobia
• with obesity level II and III
• with ECG-arrhythmia

Sponsors & Collaborators

• Medical University of Lodz: lead

Study Sites (1)

Department of Hypertension MU of Lodz

Lodz, Poland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples

MeSH Terms

Conditions

Hypertension; Heart Failure

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Heart Diseases

Study Officials

• Agata Bielecka-Dabrowa, MD, PhD

  Medical University of Lodz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Agata Bielecka-Dabrowa, PhD

CONTACT

+48606644176; agatbiel7@poczta.onet.pl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, FESC, Principal Investigator, Department of Hypertension

Study Record Dates

• First Submitted: September 21, 2011
• First Posted: October 20, 2011
• Study Start: September 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: September 1, 2014
• Last Updated: October 20, 2011

Record last verified: 2011-10

Locations

PL (1)