Haemodynamic Effects of Dobutamine and Nitrite in LV Dysfunction

The Impact of Dobutamine and Nitrite on Myocardial Supply and Demand in Heart Failure

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure
• Intervention / Treatment: Drug: Dobutamine; Drug: Nitrite

• Study Type: Observational
• Enrollment (Anticipated): 45

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE17EH
    • British Heart Foundation Centre of Excellence, The Rayne Institute, KCL, at Guy's and St Thomas' NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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%.

Description

Inclusion Criteria:

1. Left Ventricular Ejection Fraction <40%
2. Patients aged >18 years
3. Able to provide written consent

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Coronary Flow (average peak velocity)	During procedure.
left ventricular stroke work	during procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
rate pressure product	during procedure
pressure volume area	during procedure
coronary microvascular resistance	during procedure
stroke volume	during procedure
Distal tissue perfusion	during procedure
Magnitude of forward compression wave	during procedure
magnitude of backward expansion wave	during procedure

Collaborators and Investigators

• Sponsor: King's College London

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (ANTICIPATED): June 1, 2018
• Study Completion (ANTICIPATED): June 1, 2018

Study Registration Dates

• First Submitted: August 30, 2016
• First Submitted That Met QC Criteria: August 30, 2016
• First Posted (ESTIMATE): September 5, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): September 5, 2016
• Last Update Submitted That Met QC Criteria: August 30, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Adrenergic Agonists; Cardiotonic Agents; Adrenergic beta-Agonists; Sympathomimetics; Adrenergic beta-1 Receptor Agonists; Dobutamine
• Other Study ID Numbers: 199826

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO