Clinical trial NCT00170326: Progressive Ventricular Dysfunction Prevention in Pacemaker Patients
Official title: Progressive Ventricular Dysfunction Prevention in Pacemaker Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Pacing Indication classI/IIa According AHA/ACC
Keywords: Permanent Pacing artificial internal
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evolution of the ejection fraction (EF) of the left ventricle (LV) and the ventricular volumes.
timeFrame: 12 months
Secondary outcomes:
measure: Combined endpoint of cardiac mortality, appearance of HF and hospitalization due to cardiovascular problems. Morbidity.
timeFrame: 12 months
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Hospital General de Alicante
city: Badajoz
country: Spain
facility: H. Infanta Cristina
city: Barcelona
country: Spain
facility: H. Clínic i Provincial
city: Madrid
country: Spain
facility: H. Puerta de Hierro
city: Málaga
country: Spain
facility: H. C. U. Virgen de la Victoria
Study officials:
affiliation: Hospital Clínico Universitario Virgen de la Victoria, Málaga, Spain
name: Eduardo De Teresa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clinico Universitario Virgen de la Victoria, Málaga, Spain
name: Javier Alzueta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Puerta de Hierro, Madrid, Spain
name: Ignacio Fernández Lozano, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínico Universitario Virgen de la Victoria, Málaga, Spain
name: Juan José Gómez Doblas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clinic i Provincial, Barcelona, Spain
name: Francisco Navarro López, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale Civile Brescia, Italy
name: A. Curnis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medtronic Ibérica, S.A., Barcelona, Spain
name: Xavier Navarro Michel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Charite, Campus Virchow-Klinikum, Berlin, Germany
name: M. Stockburger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mount Sinai Clinical Center, Miami, FL, USA
name: Gervasio Lamas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.