Haemodynamic Effects of Dobutamine and Nitrite in LV Dysfunction

Sponsor
King's College London (Other)
Overall Status
Unknown status
CT.gov ID
NCT02888561
Collaborator
(none)
45
1
20
2.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Anticipated Enrollment :
45 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Impact of Dobutamine and Nitrite on Myocardial Supply and Demand in Heart Failure
Study Start Date :
Oct 1, 2016
Anticipated Primary Completion Date :
Jun 1, 2018
Anticipated Study Completion Date :
Jun 1, 2018

Outcome Measures

Primary Outcome Measures

  1. Coronary Flow (average peak velocity) [During procedure.]

  2. left ventricular stroke work [during procedure]

Secondary Outcome Measures

  1. rate pressure product [during procedure]

  2. pressure volume area [during procedure]

  3. coronary microvascular resistance [during procedure]

  4. stroke volume [during procedure]

  5. Distal tissue perfusion [during procedure]

  6. Magnitude of forward compression wave [during procedure]

  7. magnitude of backward expansion wave [during procedure]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 British Heart Foundation Centre of Excellence, The Rayne Institute, KCL, at Guy's and St Thomas' NHS Foundation Trust London United Kingdom SE17EH

Sponsors and Collaborators

  • King's College London

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
King's College London
ClinicalTrials.gov Identifier:
NCT02888561
Other Study ID Numbers:
  • 199826
First Posted:
Sep 5, 2016
Last Update Posted:
Sep 5, 2016
Last Verified:
May 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 5, 2016