Predictors of Response to Biventricular Pacing in Heart Failure

NCT00156390 | Completed Results

• 1 other identifier: 0504006
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 1

Brief Summary

Heart Failure (HF) is a disease of epidemic proportion in the U.S. affecting over 5 million individuals. It is estimated that in the next year nearly 400,000 new cases will be diagnosed, 1 million individuals will be hospitalized and 300,000 deaths will occur because of HF. Approximately half of the deaths will be attributed to worsening pump function while the remainder will be attributable to sudden cardiac death. Biventricular (BIV) pacing has recently emerged as an exciting new treatment of advanced HF with dramatic benefits to some patients. Current candidates include those with ventricular conduction abnormalities and reduced ejection fraction who continue to suffer from severe HF symptoms despite optimal pharmacological therapy. Recent clinical trials have demonstrated that BIV pacing improves myocardial function, functional capacity, quality of life, as well as reduces the incidence of hospitalization and even prolongs life. Despite all this, about one third of patients with HF do not benefit from BIV pacing, the so-called 'non-responders'. Our group and others have shown that there are direct genetic effects of BiV pacing in an animal model, however, there are gaps in existing knowledge about the effects of left ventricular (LV) pacing site or genetic influences on the degree of response to this novel therapy. This proposal aims at identifying predictors of benefit from Biventricular (BIV) pacing with the goal of optimizing the degree of benefit and increasing the proportion of patients who respond to this therapy. Patients who fulfill current indications for BIV pacing will undergo and echocardiography (echo) with regional tissue Doppler analysis and cardiac imaging consisting of a myocardial perfusion imaging(EGC rest gated Spect scan using Sestamibi) prior to implantation of a BIV pacing device. They will then be randomly assigned to empiric versus echo and Spect scan-guided LV lead positioning. In this latter group, optimal LV pacing site will be defined as the site of latest peak tissue velocity by tissue Doppler echo and Spect scan testing. In the empiric group, the LV lead position will be chosen by the masked operator based on the coronary sinus venous anatomy, on electrocardiographic (ECG) criteria, or other as per standard of care. Blood would be collected from all patients at the time of the procedure for analysis of genetic polymorphisms.

Conditions

Heart Failure, Wide QRS Complex

Outcome Measures

Primary Outcomes (1)

• Minnesota For Living With Heart Failure Questionnaire

  Quality of Life Questionnaire List of 21 Questions; each question has a Scale 0-5 with 0 = "no" heart failure did not prevent one from living as they want and 5= "yes"heart failure prevented one very much from living as they want. Overall scores between 0-105, with 105 being the worse quality of life.

  1 year

Secondary Outcomes (1)

• Echocardiographic Changes

  1 year

Study Arms (2)

1

EXPERIMENTAL

echo-guided LV lead placement

Device: echo-guided left ventricular lead placement

2

OTHER

LV lead placement as per standard of care (without echo-guidance)

Other: LV lead placement as per standard of care (without echo guidance)

Interventions

echo-guided left ventricular lead placement DEVICE

placement of the LV lead of the biventricular pacing device under echocardiographic guidance

1

LV lead placement as per standard of care (without echo guidance) OTHER

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age greater than 18 years Heart Failure Ejection fraction\<35% QRS complex\>120 ms

You may not qualify if:

• pregnant unable to consent

Sponsors & Collaborators

• Samir Saba: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• Saba S, Marek J, Schwartzman D, Jain S, Adelstein E, White P, Oyenuga OA, Onishi T, Soman P, Gorcsan J 3rd. Echocardiography-guided left ventricular lead placement for cardiac resynchronization therapy: results of the Speckle Tracking Assisted Resynchronization Therapy for Electrode Region trial. Circ Heart Fail. 2013 May;6(3):427-34. doi: 10.1161/CIRCHEARTFAILURE.112.000078. Epub 2013 Mar 8.

  PMID: 23476053 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Samir Saba
• Organization: University of Pittsburgh

sabas@upmc.edu

412-802-3372

Study Officials

• Samir Saba, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Cardiac Electrophysiology, UPMC

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: June 1, 2005
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: November 6, 2019
• Results First Posted: November 24, 2014

Record last verified: 2019-11

Locations

US (1)