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Clinical Trials/NCT02888561
NCT02888561UnknownNot Applicable

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

King's College London1 site in 1 country45 target enrollmentStarted: October 2016Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Enrollment
45
Locations
1
Primary Endpoint
Coronary Flow (average peak velocity)

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 100 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Coronary Flow (average peak velocity)

Time Frame: During procedure.

left ventricular stroke work

Time Frame: during procedure

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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