Haemodynamic Effects of Dobutamine and Nitrite in LV Dysfunction

NCT02888561 | Unknown

• 1 other identifier: 199826
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with poor heart function can, in certain situations, have a further weakening of the heart muscle such that it becomes difficult to provide enough blood to the brain and other organs. In these cases, heart function can be supported by the use of medicines or heart pumps. One of the most widely used medicines is Dobutamine, given as an infusion (a drip). Although Dobutamine has been in use for decades and does improve blood flow to the organs, previous studies have not shown any impact on recovery of heart muscle function and survival. Key to unravelling this discrepancy is to understand the precise effects of Dobutamine on the oxygen supply to, and oxygen usage by, the heart muscle. We also aim to find out whether simultaneous infusion of another drug called Nitrite (naturally occurring substance that is found in beetroot for example, much like GTN) can enhance the beneficial effects of Dobutamine on the oxygen supply-demand balance of the heart. In recent years, major advances in technology mean that it is now possible to obtain this information in patients undergoing coronary angiography procedures by making detailed measurements of heart muscle function and blood flow in the heart arteries using a conductance catheter (measures volume and pressure within the main pumping chamber of the heart) and the Combowire (dual pressure and flow sensor tip angioplasty guidewire). The aim of this study is to understand the effect of a brief infusion of Dobutamine and nitrite on heart muscle function, oxygen supply and oxygen usage through this use of this technology, directly following the patients routine coronary angiogram. Patients will have these measurements taken using the technology described above during the infusion of both dobutamine and nitrite, inserted through blood vessels that reach the heart.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• Coronary Flow (average peak velocity)

  During procedure.

• left ventricular stroke work

  during procedure

Secondary Outcomes (7)

• rate pressure product

  during procedure

• pressure volume area

  during procedure

• coronary microvascular resistance

  during procedure

• stroke volume

  during procedure

• Distal tissue perfusion

  during procedure

Interventions

Dobutamine DRUG

Dobutamine will be infused at the time of coronary angiography while coronary and LV haemodynamics are measured using a Combowire (dual pressure and flow sensor tip guide wire) and left ventricular conductance catheter.

Nitrite DRUG

Nitrite will be infused at the time of coronary angiography while coronary and LV haemodynamics are measured using a Combowire (dual pressure and flow sensor tip guide wire) and left ventricular conductance catheter.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred for diagnostic coronary angiography following a diagnosis of heart failure, with a left ventricular ejection fraction of less than or equal to 40%.

You may qualify if:

• Left Ventricular Ejection Fraction \<40%
• Patients aged \>18 years
• Able to provide written consent

You may not qualify if:

• Known acquired or congenital structural heart disease such as severe valve disease, ventricular/atrial septal defects
• Haemodynamic Instability
• Severe disease in major proximal coronary arteries or planned percutaneous coronary intervention during the index procedure

Sponsors & Collaborators

• King's College London: lead

Study Sites (1)

British Heart Foundation Centre of Excellence, The Rayne Institute, KCL, at Guy's and St Thomas' NHS Foundation Trust

London, SE17EH, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Dobutamine; Nitrites

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Catecholamines; Amines; Organic Chemicals; Phenethylamines; Ethylamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Anions; Ions; Electrolytes; Inorganic Chemicals; Nitrous Acid; Nitrogen Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2016
• First Posted: September 5, 2016
• Study Start: October 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: September 5, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)