Progressive Ventricular Dysfunction Prevention in Pacemaker Patients (Prevent-HF)

The purpose of this pilot study is to evaluate the progression of ventricular dysfunction in patients with ventricular dysfunction within the permanent pacing population.

Study Overview

• Status: Completed
• Conditions: Cardiac Pacing Indication classI/IIa According AHA/ACC
• Intervention / Treatment: Procedure: dual-chamber pacemaker implantation; Procedure: biventricular dual-chamber pacemaker implant

Detailed Description

The interventricular synchrony is one of the components of a proper cardiac function. When there is no synchrony -as in left bundle block (LBBB)- the clinic consequences should have little importance in patients with a healthy heart or a great importance in patients suffering heart failure (HF), specially in those with severe grade of HF, the benefit of cardiac resynchronization by pacing both ventricles or left ventricle (LV)should means healthy improvement in patients. All previous studies done in HF, are in patients with symptomatic HF. The importance of stop progression of latent HF in patients with asymptomatic ventricular dysfunction (VD)in permanent pacing indication patients. Pacing may accelerate HF progression by dissincronyzing ventricles. ACE inhibitors studies in asymptomatic VD gave positive results.

The PreVent-HF is an international, multicenter, prospective, randomized, single-blinded pilot trial specifically designed to evaluate as main objective the progression of VD in permanent pacing population.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Alicante, Spain
    • Hospital General de Alicante
  • Badajoz, Spain
    • H. Infanta Cristina
  • Barcelona, Spain
    • H. Clinic i Provincial
  • Madrid, Spain, 28035
    • H. Puerta de Hierro
  • Málaga, Spain
    • H. C. U. Virgen de la Victoria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Meet Class I and/or Class IIa implantation criteria for permanent cardiac pacing according to the guidelines given by the American College of Cardiology (ACC)/American Heart Association(AHA).

Exclusion Criteria:

• Expected ventricle stimulation <80% of the time
• Impossibility of dual chamber stimulation in the absence of AF
• Severe heart failure (NYHA Functional class III-IV) previous to indication for pacing device implant
• Patient needs revascularization within 3 months
• Myocardial infarction in the last 3 months
• Cardiac surgery performed in the last 3 months
• Hypertrophic cardiomyopathy
• Constrictive pericarditis
• Bad echo window
• Previous system implanted (ICD or pacemaker)
• Aortic stenosis
• Patient has a mechanical right heart valve
• Patient <18 years
• Pregnancy
• Patient has medical conditions that would preclude the testing required by the protocol, or limit study participation
• Life expectancy <1year
• Patient is unwilling or unable to cooperate or give written informed consent.
• Patient is or will be inaccessible for follow-up at the study center.
• Patients who are participating or planning to participate in other clinical trials during the clinical study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dual Chamber pacing; conventional dual-chamber pacemaker/ICD implantation with the ventricular lead in the right ventricular apex	Procedure: dual-chamber pacemaker implantation; Dual Chamber pacing via conventional DDD(R) right ventricular pacemaker or in case of ICD indication a standard dualchamber ICD device.; Other Names: DDD pacing, RV
Experimental: Biventricular pacing; Biventricular pacing: dual-chamber biventricular pacemaker/ICD implantation with leads at the right ventricular apex and the left ventricle	Procedure: biventricular dual-chamber pacemaker implant; Biventricular pacemaker system or in case in ICD indication a BIV ICD; Other Names: InSync 8040, InSync III 8042

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evolution of the ejection fraction (EF) of the left ventricle (LV) and the ventricular volumes.	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Combined endpoint of cardiac mortality, appearance of HF and hospitalization due to cardiovascular problems. Morbidity.	12 months

Collaborators and Investigators

• Sponsor: Medtronic Bakken Research Center
• Investigators: Principal Investigator: Eduardo De Teresa, MD, Hospital Clínico Universitario Virgen de la Victoria, Málaga, Spain; Principal Investigator: Javier Alzueta, MD, Hospital Clínico Universitario Virgen de la Victoria, Málaga, Spain; Principal Investigator: Ignacio Fernández Lozano, MD, Hospital Puerta de Hierro, Madrid, Spain; Principal Investigator: Juan José Gómez Doblas, MD, Hospital Clínico Universitario Virgen de la Victoria, Málaga, Spain; Principal Investigator: Francisco Navarro López, MD, Hospital Clinic i Provincial, Barcelona, Spain; Principal Investigator: A. Curnis, MD, Ospedale Civile Brescia, Italy; Principal Investigator: Xavier Navarro Michel, MD, Medtronic Ibérica, S.A., Barcelona, Spain; Principal Investigator: M. Stockburger, MD, Charite, Campus Virchow-Klinikum, Berlin, Germany; Principal Investigator: Gervasio Lamas, MD, Mount Sinai Clinical Center, Miami, FL, USA

Publications and helpful links

General Publications

• de Teresa E, Gomez-Doblas JJ, Lamas G, Alzueta J, Fernandez-Lozano I, Cobo E, Navarro X, Navarro-Lopez F, Stockburger M. Preventing ventricular dysfunction in pacemaker patients without advanced heart failure: rationale and design of the PREVENT-HF study. Europace. 2007 Jun;9(6):442-6. doi: 10.1093/europace/eum064. Epub 2007 Apr 25.
• Stockburger M, Gomez-Doblas JJ, Lamas G, Alzueta J, Fernandez-Lozano I, Cobo E, Wiegand U, Concha JF, Navarro X, Navarro-Lopez F, de Teresa E. Preventing ventricular dysfunction in pacemaker patients without advanced heart failure: results from a multicentre international randomized trial (PREVENT-HF). Eur J Heart Fail. 2011 Jun;13(6):633-41. doi: 10.1093/eurjhf/hfr041.
• Stockburger M, de Teresa E, Lamas G, Desaga M, Koenig C, Habedank D, Cobo E, Navarro X, Wiegand U. Exercise capacity and N-terminal pro-brain natriuretic peptide levels with biventricular vs. right ventricular pacing for atrioventricular block: results from the PREVENT-HF German Substudy. Europace. 2014 Jan;16(1):63-70. doi: 10.1093/europace/eut217. Epub 2013 Jul 16.

Study record dates

Study Major Dates

• Study Start: January 1, 2002
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 15, 2005

Study Record Updates

• Last Update Posted (Actual): April 19, 2017
• Last Update Submitted That Met QC Criteria: April 18, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Permanent Pacing artificial internal
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction
• Other Study ID Numbers: PreVent-HF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No