---
title: Haemodynamic Effects of Dobutamine and Nitrite in LV Dysfunction
nct_id: NCT02888561
overall_status: UNKNOWN
sponsor: "King's College London"
study_type: OBSERVATIONAL
primary_condition: Heart Failure
countries: United Kingdom
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02888561.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02888561"
ct_last_update_post_date: 2016-09-05
last_seen_at: "2026-05-12T06:17:20.814Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Haemodynamic Effects of Dobutamine and Nitrite in LV Dysfunction

**Official Title:** The Impact of Dobutamine and Nitrite on Myocardial Supply and Demand in Heart Failure

**NCT ID:** [NCT02888561](https://clinicaltrials.gov/study/NCT02888561)

## Key Facts

- **Status:** UNKNOWN
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 45
- **Lead Sponsor:** King's College London
- **Conditions:** Heart Failure
- **Start Date:** 2016-10
- **Completion Date:** 2018-06
- **CT.gov Last Update:** 2016-09-05

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 100 Years
- **Sex:** ALL
- **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
```

## 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.

## Primary Outcomes

- **Coronary Flow (average peak velocity)** _(time frame: During procedure.)_
- **left ventricular stroke work** _(time frame: during procedure)_

## Secondary Outcomes

- **rate pressure product** _(time frame: during procedure)_
- **pressure volume area** _(time frame: during procedure)_
- **coronary microvascular resistance** _(time frame: during procedure)_
- **stroke volume** _(time frame: during procedure)_
- **Distal tissue perfusion** _(time frame: during procedure)_
- **Magnitude of forward compression wave** _(time frame: during procedure)_
- **magnitude of backward expansion wave** _(time frame: during procedure)_

## Locations (1)

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

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.british heart foundation centre of excellence, the rayne institute, kcl, at guy's and st thomas' nhs foundation trust|london||united kingdom` — added _(2026-05-12)_

---

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