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NITRATE-OCT-CIN (Sub-Study of NITRATE-OCT)

NCT05544981 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2023-06-05

No results posted yet for this study

Summary

The NITRATE-OCT:- Contrast Nephropathy Sub-study is a proof-of concept single center, randomized, clinical trial designed to ascertain whether a dietary NO3- approach might prove useful adjunctive therapy improving renal function and reducing CIN in patients with stable angina undergoing elective angioplasty.

Objectives: To determine whether dietary NO3- ingestion exerts any effect on the glomerular filtration rate (GFR) after the exposure to contrast media.

To determine if dietary NO3- ingestion will decrease the incidence of contrast induced nephropathy.

Setting: The patients will be recruited from an on-going clinical trial NITRATE-OCT. This is a study assessing whether the use of dietary NO3- may reduce the incidence of restenosis following elective angioplasty. This study is recruiting patients with stable angina and single/multiple coronary artery stenosis undergoing elective PCI who are haemodynamically stable (systolic BP\>100 mmHg). These patients will be recruited at The Barts Heart Centre at St Bartholomew's Hospital. This is one of the biggest centres in the UK, serving a population of almost two million people from The City of London and The North East up to the M25 and is a 24/7 centre performing approximately 3000 angioplasties a year.

The study will take place in the Clinical Trials Unit, William Harvey Heart Centre.

Target population: A total of 246 patients (male and female, age 18-85) with stable angina as per requirements indicated above. Follow-up will take place in the Clinical Trials Unit, William Harvey Research Institute.

Treatment: Patients will be randomised (using an on line randomisation database) to receive 70 ml of a beetroot juice concentrate containing 4-5 mmol nitrate or nitrate-depleted placebo juice concentrate. This intervention will be taken by the patient daily from one day prior to re-establishment of flow with PCI and stent implantation.

Conditions

Interventions

DIETARY_SUPPLEMENT

Beetroot Juice

70 ml of beetroot juice containing \~5 mmol of inorganic nitrate

DIETARY_SUPPLEMENT

Beetroot Juice

70 ml of beetroot juice which is nitrate-depleted

Sponsors & Collaborators

  • Queen Mary University of London

    lead OTHER

Principal Investigators

  • Daniel A Jones, MBBS, PhD · Queen Mary University of London

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-02
Primary Completion
2022-12-02
Completion
2022-12-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05544981 on ClinicalTrials.gov