Novel Vascular Biomarkers Behaviour and Clinical Value in Heart Failure and CRT

NCT02541773 | Unknown

• 1 other identifier: version 10 20 Jan 2016
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to understand the behaviour of certain blood markers in patients with heart failure who undergo a cardiac device implantation procedure called cardiac resynchronization therapy (CRT). CRT is an effective treatment for heart failure, but up to 30% of people do not respond and have poor outcomes (1,2). Despite extensive investigation, identifying these patients continues to be a challenge. The study intends to describe the changes in these blood markers before and after CRT and to examine any potential clinical value. The idea behind the study is that these blood markers alter in heart failure and change with CRT implantation. Furthermore the pattern of marker expression before implant and after may predict response and outcome.

Conditions

Chronic Heart Failure

Keywords

Chronic Heart Failure; Cardiac Resynchronization Therapy; Vascular Biomarker; miRNA; Extracellular Matrix; Brain Natruetic Peptide; Growth Degradation Factor-15; Body Composition

Outcome Measures

Primary Outcomes (1)

• Clinical Response

  Two of three criteria must be fulfilled to be defined as a clinical response: 1. New York Heart Association (NYHA) \> 1 class reduction from baseline 2. Minnesota Living with Heart Failure Questionnaire (MLHFQ) score \< 5 from baseline 3. Six minute walk test (6MWT) increase in baseline distance by 10% Mortality or heart transplantation within 6 months of implant will be defined as a non-response.

  6 months

Secondary Outcomes (2)

• Major Adverse Cardiovascular Outcomes

  12 months

• Echocardiographic Response

  6 months

Study Arms (1)

Chronic Heart Failure Patients

Undergoing CRT implantation, all will be observed for 6 months and will be defined at the end of the observation period as responder or non-responder

Device: Cardiac Resynchronisation Therapy

Interventions

Cardiac Resynchronisation Therapy DEVICE

Routine implantation of CRT - part of standard of care

Chronic Heart Failure Patients

Eligibility Criteria

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

Study Population

Chronic heart failure patients who have been referred for and meet national criteria for Cardiac Resynchronization Therapy implants

You may qualify if:

• Age \> 18 years
• Left ventricular ejection fraction ≤35% on echocardiography
• NYHA Class III/IV symptoms or milder symptoms with:
• NYHA I (LVEF \<35% and QRS\>150msec on resting ECG)
• NYHA II (LVEF \<35% with either QRS\>150msec or QRS 120-149msec with Left Bundle Branch Block on resting ECG)
• Optimal medical therapy for heart failure that the patient tolerates (ACEi, Beta-Blocker, Mineralocorticoid) for \> 3 months
• QRS duration ≥120-149msec with LBBB on resting ECG or QRS duration \>150msec on resting ECG
• Patient consent to participation in the study

You may not qualify if:

• Acute heart failure decompensation \< 6/52 before implant
• Significant cognitive impairment
• Acute coronary syndrome \< 6/52 before implant
• Chronic kidney disease stage V (requiring dialysis)
• Terminal illness with likely survival \< 1 year after implant
• \. Failure of procedure (e.g. coronary sinus anatomy) 2. Complication resulting in poor/ none biventricular pacing (e.g. phrenic nerve stimulation, lead displacement/ damage)

Sponsors & Collaborators

• University Hospitals Coventry and Warwickshire NHS Trust: lead
• Medtronic: collaborator

Study Sites (1)

University Hospital Coventry and Warwickshire

Coventry, Warwickshire, CV2 2DX, United Kingdom

Location

Related Publications (19)

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  PMID: 30364565 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Participants with have peripheral and coronary sinus samples taken for plasma and serum.

MeSH Terms

Interventions

Cardiac Resynchronization Therapy

Intervention Hierarchy (Ancestors)

Cardiac Pacing, Artificial; Electric Stimulation Therapy; Therapeutics

Study Officials

• Faizel Osman, MD FRCP FESC

  University Hospital Coventry and Warwickshire

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiology Research Fellow

Study Record Dates

• First Submitted: September 2, 2015
• First Posted: September 4, 2015
• Study Start: November 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: March 9, 2016

Record last verified: 2015-09

Locations

GB (1)