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Valsartan to Prevent Left Ventricle Remodeling in Pacemaker Patients

NCT01805804 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2023-04-12

No results posted yet for this study

Summary

Dual chamber pacing is known to induce left ventricle remodeling and may eventually lead to heart failure. The investigators aim to test hypothesis that valsartan started immediately after dual chamber pacemaker implantation will prevent left ventricle remodeling in twelve months long follow up in comparison with placebo. Echocardiographic assessment of left ventricle remodeling will be correlated with plasma activity of matrix metalloproteinases and their tissue inhibitors, indices of functional capacity such as plasma level of NTproBNP and distance in meters during six minute walking test.

Conditions

  • First Time Dual Chamber Pacemaker Implantation

Interventions

DRUG

placebo/valsartan

Sponsors & Collaborators

  • Polpharma Pharmaceutical Company

    collaborator UNKNOWN

  • Medical University of Silesia

    lead OTHER

Principal Investigators

  • Ewa Nowalany-Kozielska, MD PhD Associate Professor · Medical University of Silesia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2019-01-31
Completion
2019-01-31

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01805804 on ClinicalTrials.gov