Heart Failure in Patients With Diabetes: Cells, Crosstalk and Consequences
3 other identifiers
observational
600
1 country
1
Brief Summary
This will be an observational study to explore differences in pathophysiology between groups of people with and without heart failure (HF) (reduced and preserved ejection fraction) and with and without diabetes mellitus (DM) with a particular focus on cross-talk (fat, muscle, vascular tissue and the heart). The investigators will invite 600 people to partcipate (100 with HFrEF+DM, 100 with HFpEF+DM, 100 with HFpEF-DM, 100 with HFrEF-DM, 100 with DM, 100 without either HR or DM). Special heart scans, exercise testing, blood testing, testing of the automatic nervous system will be performed and in some, samples of fat and muscle and endothelial cells will be collected. These data will be used to create a cohort of well phenotyped patients with a variety of comprehensively collected clinical information, a cell atlas, and a comprehensive assessment of metabolomics, proeomics and cross-talk in between tissues, allowing comparisons between each group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2025
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 8, 2025
CompletedFirst Posted
Study publicly available on registry
January 14, 2025
CompletedStudy Start
First participant enrolled
February 26, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2030
February 28, 2025
February 1, 2025
4.9 years
January 8, 2025
February 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Study primary endpoint
Are there differences in skeletal muscle cellular metabolism assessed by mass spectrometry-based metabolomics and lipidomics between the two phenotypes of heart failure compared with controls and what influence does diabetes mellitus have?
5 years
Secondary Outcomes (9)
Secondary outcome 1
5 years
Secondary outcome 2
5 years
Secondary outcome 3
5 years
Secondary outcome 4
5 years
Secondary outcome 5
5 years
- +4 more secondary outcomes
Study Arms (6)
HFrEF-DM
People with heart failure due to reduced ejection fraction without diabetes mellitus
HFrEF+DM
People with heart failure due to reduced ejection fraction who also have diabetes mellitus
HFpEF-DM
People with heart failure with preserved ejection fraction without diabetes mellitus
HFpEF+DM
People with heart failure with preserved ejection fraction who also have diabetes mellitus
DM
People who have diabetes mellitus but do not have heart failure
Control
People who have neither heart failure nor diabetes mellitus
Eligibility Criteria
People attending heart failure clinics, diabetes clinics (either secondary or primary care) or control subjects attending hospital with relatives or accumulated from the community by word of mouth or advertisement.
You may qualify if:
- Age \>18 years
- Ability to provide written informed consent
- Persons who are legally competent and mentally able to follow the instructions of the study staff
You may not qualify if:
- Anaemia Hb \<8 mg/dl
- Patients with acute infectious diseases (e.g. pneumonia)
- Patients with heart failure due to sepsis
- People with acute myocardial ischemia, which is manifested, for example, by angina pectoris or ECG changes under stress
- Patients with acute liver or kidney failure or severe COPD (FEV1\<1.0)
- Pregnant and breastfeeding women
- People who are institutionalized on official or court orders
- People who are dependent or employed by the sponsor or investigator
- Taking study medication (of an investigational drug) 30 days before the start of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, LS16 5AR, United Kingdom
Biospecimen
Blood, fat, muscle, endothelial cells
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Lecturer in Cardiology
Study Record Dates
First Submitted
January 8, 2025
First Posted
January 14, 2025
Study Start
February 26, 2025
Primary Completion (Estimated)
January 31, 2030
Study Completion (Estimated)
January 31, 2030
Last Updated
February 28, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- 6 months after the end of the study
- Access Criteria
- Requests to be made to the Trial Management Group
An anonymised version of the database and the samples will be available to other researchers including outside of the University of Leeds in response to a reasonable request and confirmation of appropriate data protection policies and a mutual data sharing agreement.