How heart rate affects heart pumping strength in people with heart failure and diabetes
The Force Frequency Relationship in Heart Failure: an Expression of a Metabolic Problem Driving Adverse Remodelling?
Researchers will test whether abnormal metabolism in the heart and skeletal muscle explains why people with heart failure, especially those with diabetes, do not increase heart pumping effectively when their heart rate rises.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Leeds Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Leeds, West Yorkshire) |
| Trial ID | NCT07309523 on ClinicalTrials.gov |
What this trial studies
This observational study will recruit patients undergoing pacemaker or defibrillator implantation and take small samples of fat and muscle from the operation site, with thigh muscle taken in a subgroup, plus blood samples from coronary, peripheral venous, and arterial sites during different paced heart rates and modes. Coded tissue and blood samples will be stored for metabolomic analysis to identify metabolic pathways linked to an abnormal force–frequency relationship (FFR). Patients will be followed for six months with cardiac ultrasound and non-invasive cardiac monitoring to chart left ventricular FFR and clinical progression. The goal is to link cardiac and peripheral metabolic changes, and the influence of diabetes, to abnormalities in how the heart increases contraction with higher rates.
Who should consider this trial
Good fit: Adults (>18 years) who have a guideline-based indication for pacemaker or defibrillator implantation, can give informed consent, and are able to attend implantation and follow-up visits are eligible, including those with heart failure with or without diabetes.
Not a fit: People who do not need a device implant, those with acute infections, acute ischemia, severe kidney or liver failure, significant anemia, pregnancy, or other listed exclusions are unlikely to benefit from or be eligible for this protocol.
Why it matters
Potential benefit: If successful, the work could identify metabolic targets that lead to new ways to improve heart performance in people with heart failure and those with diabetes.
How similar studies have performed: Prior research has linked metabolic abnormalities to heart failure, but this specific approach combining intraoperative tissue and multi-site blood sampling with paced FFR measurements is relatively novel and not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Anemia 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 * 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 * Known contrast allergy or eGFR \<20ml/min/1.73m2 * Pregnancy not excluded by bedside pregnancy test in premenopausal women
Where this trial is running
Leeds, West Yorkshire
- Leeds Teaching Hospitals NHS Trust — Leeds, West Yorkshire, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Klaus K Witte, MD
- Email: k.k.witte@leeds.ac.uk
- Phone: 00441133926642
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.