How heart rate and metabolism relate in heart failure and diabetes
Studies blood and tissue samples from adults having a pacemaker or defibrillator fitted.
Key facts
- Who runs it
- University of Leeds
- Where
- Leeds, United KingdomSee the site
- Trial code
- Registry title
- The Force Frequency Relationship in Heart Failure and Diabetes Mellitus: a Metabolic Aetiology?
- Status
- Recruiting
- People taking part
- 160 people, planned
- Started
- 1 Sept 2024
- Expected to end
- 30 Aug 2034
- Type of study
- Observational, 4 groups
- Record updated
- 5 January 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who have a medical reason for a pacemaker implant. Blood and tissue samples are taken during the procedure, then heart function is checked over 6 months.
- Age
- Over 18 years
- Sex
- All sexes
- Disease stage
- A guideline-based clinical reason for a pacemaker implant. The record's conditions are heart failure and diabetes.
- Earlier treatment
- Cannot have taken a study drug (investigational drug) in the 30 days before the study starts.
Main reasons for not taking part
- Anemia with Hb <8 mg/dl
- Acute infection such as pneumonia, or heart failure due to sepsis
- Acute heart muscle ischemia, or acute liver or kidney failure
- Pregnant or breastfeeding women
- Known contrast allergy or eGFR <20ml/min/1.73m2
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- Guideline-compliant, clinical indication for pacemaker implantation
- 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
Who cannot take part
- Taking study medication (of an investigational drug) 30 days before the start of the study
- 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
- Anemia Hb <8 mg/dl
- Known contrast allergy or eGFR <20ml/min/1.73m2
- Pregnant and breastfeeding women
- People who are institutionalized on official or court orders
- People who are dependent or employed by the sponsor or investigator
- Pregnancy not excluded by bedside pregnancy test in premenopausal women
Where in United Kingdom
- Leeds Teaching Hospitals NHS TrustLeeds, United KingdomContact: Klaus Witte, MDTaking people
About the trial
What the trial wants to find out
The present investigation is a non-randomised, observational study involving an unselected but highly phenotyped cohort of patients undergoing pacemaker or defibrillator implantation from whom a small sample of fat and muscle will be taken from the operation site, and, in a subgroup, from the thigh muscle. A sample of blood wil also be taken from the vein of the heart, a peripheral vein and the artery at the wrist during the procedure at different heart rates and pacing modes, to describe how heart rate and heart contraction power relate to cardiac and peripheral metabolism.
Read full original descriptionShow less
The coded blood and tissue samples and anonymised clinical data will be stored in a Human Tissue Authority-approved freezer until analysis.
Following the procedure, during routine visits, patients' left ventricular force frequency relationship will be assessed using cardiac ultrasound and a non-invasive cardiac monitor to further phenotype the severity and progression of their heart function over 6 months. For most patients, their involvement will end at that point although they will be monitored through electronic health records on an annual basis from that point forward for up to 5 years after the end of the study (for up to ten years after that point) to gain information on the prognostic value of the metabolic and haemodynamic testing.
The present investigation will allow the investigators to advance the understanding of heart-muscle crosstalk with the goal of developing targeted interventions that could open new treatment avenues.
The 4 groups in the trial
- HFrEF without DM
People with heart failure due to reduced ejection fraction
- HFrEF with DM
People with heart failure due to reduced ejection fraction who also have diabetes mellitus
- No HF, no DM
People without heart failure who also do not have diabetes mellitus
- No HF but with DM
People without heart failure but who do have diabetes mellitus
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The Force Frequency Relationship in Heart Failure: an Expression of a Metabolic Problem Driving Adverse Remodelling?
- Plain-language title
- How heart rate and metabolism relate in heart failure and diabetesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 5 January 2026