The Force Frequency Relationship in Heart Failure and Diabetes Mellitus: a Metabolic Aetiology?

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Leeds

About this trial

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.

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

People having an implantable cardiac device procedure

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

160 Participants
are grouped into 4 trial groups
Group A: HFrEF without DM
Group B: HFrEF with DM
Group C: No HF, no DM
Group D: No HF but with DM

Trial outcomes

Primary outcomes

1

Relationship between FFR and cardiac metabolomics

Is cardiac metabolism in patients with diabetes and diabetes with heart failure as assessed by mass spectrometry-based metabolomics and lipidomics abnormal at higher heart rates and is the degree of the impairment correlated with the heart rate at which peak contractility occurs?

Time frame
At baseline

Secondary outcomes

Other outcomes

Sponsors and contacts

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