Nutritional Screening in Cardiovascular Disease | NCT07409519

Studies
Nutritional Screening in Cardiovascular Disease

NCT07409519

Sponsor

Hull University Teaching Hospitals NHS Trust

Status

Recruiting

Last Update Posted

Jun 23, 2026Actual

Enrollment

250Estimated

Phase

Not provided

Conditions

Cardiovascular Diseases

Interventions

Nutritional Screening

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 20, 2025Actual

Primary Completion Date

Dec 18, 2026Estimated

Completion Date

Jan 10, 2027Estimated

First Submitted Date

May 21, 2025

First Submission Date that Met QC Criteria

Feb 12, 2026

First Posted Date

Feb 13, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2026

Last Update Posted Date

Jun 23, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a nutritional screening and assessment study conducted prior to heart surgery. The nutritional status of patients will be assessed by a series of questionnaires, blood/urine biomarkers and measurement of grip strength and body composition. The investigators will then evaluate of any of the assessments are linked with clinical outcomes following surgery. For example, how long do patients stop in the intensive care unit (ICU), in hospital and how many complications patients experience.

The investigators hope to use this important clinical data to understand how medical staff can identify a poor nutritional status and which patients may need nutritional support prior to surgery.

Detailed Description

This is a cross sectional nutritional screening and assessment study conducted prior to cardiac surgery . The investigators will focus on comparing aspects of nutritional status with robust and validated clinical outcomes (mechanical ventilation, ICU time, hospital stay and Society of Cardiothoracic Surgery (SCTS) complications). The investigators will utilise various nutritional screening questionnaires and assessments, including routine clinical malnutrition tools (i.e. MUST, NRS), plus more nutritional quality assessments such as the NOVA ultra-processed food intake, mediterranean diet and blood biomarker panels such as the Prognostic Nutritional Index (PNI), Controlling Nutritional Status (CONUT).

The investigators will also undertake a functional grip strength test and measure body composition including fat mass (FM) & fat-free mass (FFM), segmental analysis, sarcopenic obesity and visceral fat. The study will also conduct questionnaires regarding other lifestyle related factors (sleep, recent physical activity, stress, anxiety, depression) which might also influence surgical outcomes.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

250Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Surgical- Group 1			Behavioral: Nutritional Screening

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nutritional Screening	Behavioral	To identify which nutritional screening approaches (nutritional questionnaires, biomarkers, sarcopenic obesity or grip strength are most strongly linked to surgical outcomes following cardiac surgery.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time in ICU	The total time in hours spent in the ICU, calculated from ICU admission following cardiac surgery to ICU discharge to the general cardiology ward	From ICU admission until ICU discharge, up to 30 days
Complications post cardiac surgery	The number of Society of Cardio-thoracic Surgery register of complications	Number of complications following cardiac surgery, up to 30 days
Length of Hospital Stay	Length of hospital stay from admission to medical discharge	From hospital admission until hospital discharge, up to 30 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

• No pre-specified inclusion criteria to ensure we recruit a representative group of patients.

Exclusion Criteria:

All patients without proficiency in English that allows completion of questionnaires
Unable to provide written consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing routine NHS cardiac surgery

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mahmoud M Loubani, MD	Contact	+44 (1482) 624379		mahmoud.loubani@nhs.net
James P Hobkirk, PhD	Contact	+44 (0)7894 264660		james.hobkirk3@nhs.net

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hull University Teaching Hospitals NHS Trust	Recruiting	Hull	E. Riding Yorkshire	HU16 5JQ	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All collected anonymised data will be shared if the proposal is deemed to be of sufficient standard.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002318	Cardiovascular Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided