Impact of Cardiac Resynchronization Therapy on Right Ventricular Function

Status Withdrawn

Clinical Trial Summary

Left Ventricular Assist Devices (LVAD) are mechanical heart pumps that are increasingly being implanted in patients with severe heart failure which have failed medical therapy. In patients with LVADs, right ventricular failure, which is not supported by the LVAD pump, is a major problem that affects quality-of-life and survival. Cardiac Resynchronization Therapy (CRT) aims to restore the synchronized contraction of the heart and has proven to be beneficial for improving ejection fraction of both right and left ventricle as well as quality of life in selected heart failure patients. The role of CRT in patients with LVADs is unknown. We hypothesize that CRT can exert a beneficial impact on right ventricular function in LVAD patients and improve their quality-of-life.

The specific questions that this study aims to answer are:

1. What are the effects of CRT on the function of the non-supported right ventricle in patients with an implanted LVAD?

2. Can the effects of CRT on cardiac function positively impact quality-of-life and exercise capacity in LVAD recipients?

In this study patients with a previously implanted CRT device, who later receives an LVAD, will be randomly assigned to have the CRT turned off (CRT-off) or on (CRT-on). The patients will be followed for an 8-week period, and then switched over to the opposite CRT status. The total participation in this study will last for 16 ± 1 weeks, and will involve 3 clinic visits of approximately 3 hour duration (initial visit, 8 week visit, and 16 week final visit), plus 2 quick checks of the pacemaker/defibrillator in-between the visits. Heart function will be assessed with comprehensive echocardiographic studies during the CRT "on" and CRT "off" periods. Quality-of-life and exercise capacity will be assessed with a standardized questionnaire and a 6-Minute Walk Test.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Heart Failure

Clinical Trial Details

NCT number	NCT02169076
Study type	Interventional
Source	University of Louisville
Contact
Status	Withdrawn
Phase	N/A
Start date	September 2014
Completion date	May 2016

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05196659` - Collaborative Quality Improvement (C-QIP) Study	N/A
Recruiting	`NCT05654272` - Development of CIRC Technologies
Recruiting	`NCT05650307` - CV Imaging of Metabolic Interventions
Active, not recruiting	`NCT05896904` - Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction	N/A
Completed	`NCT05077293` - Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
Recruiting	`NCT05631275` - The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
Enrolling by invitation	`NCT05564572` - Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology	N/A
Enrolling by invitation	`NCT05009706` - Self-care in Older Frail Persons With Heart Failure Intervention	N/A
Recruiting	`NCT04177199` - What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
Terminated	`NCT03615469` - Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY)	N/A
Recruiting	`NCT06340048` - Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure	Phase 1/Phase 2
Recruiting	`NCT05679713` - Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
Completed	`NCT04254328` - The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure	N/A
Completed	`NCT03549169` - Decision Making for the Management the Symptoms in Adults of Heart Failure	N/A
Recruiting	`NCT05572814` - Transform: Teaching, Technology, and Teams	N/A
Enrolling by invitation	`NCT05538611` - Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
Recruiting	`NCT04262830` - Cancer Therapy Effects on the Heart
Completed	`NCT06026683` - Conduction System Stimulation to Avoid Left Ventricle Dysfunction	N/A
Withdrawn	`NCT03091998` - Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support	Phase 1
Recruiting	`NCT05564689` - Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Impact of Cardiac Resynchronization Therapy on Right Ventricular Function in Left Ventricular Assist Device Patients — CRT-LVAD

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms