How heart rate affects heart pumping strength in people with heart failure and diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.