Health TrialsbyHealthPanel

Arterial Stiffness and Endothelial Function in Heart Failure

ConditionHeart Failure
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorCoventry University

About this trial

Heart Failure (HF) is a global condition affecting at least 26 million people worldwide. Despite advances in treatment, HF patients continue to experience poor health outcomes. This study aims to improve understanding of the role of blood vessels in people with heart failure.

The study will assess how arterial stiffness (how stiff blood vessels are) and endothelial function (how well the lining of blood vessels functions) change over time and respond to treatments received as part of routine clinical care. Blood vessel function and heart performance will be assessed at three time points:

* At baseline (when Patients are first diagnosed with heart failure). * After completing 4 ± 2 weeks of heart-failure medicines prescribed to patients as part of their routine clinical care. * After completion of cardiac rehabilitation program as a part of their routine clinical care.

All assessments are non-invasive.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male and female ≥ 18 years old.

Have a confirmed de-novo diagnosis of Heart failure with preserved ejection fraction or Heart failure with reserved ejection fraction. Common HF phenotypes (e.g., hypertension, diabetes, obesity) will be recorded as part of routine baseline data but will not influence recruitment or sampling. .

Have stable Heart failure in the opinion of the investigator.

Have ability, in the opinion of the investigator, to participate in study activities.

Disqualifiers

• Inability to provide verbal informed consent.

Presenting with severe symptoms; major co-morbidity or other alternative diagnoses (e.g., malignancy, severe respiratory disease, severe mental health problem/s).

Recent acute coronary syndrome (within 60 days).

Severe physical disability preventing independence.

Trial population

Potential participants will be identified through the Heart failure service at University Hospitals Coventry \& Warwickshire. Members of the patient's existing direct clinical care team will review clinic lists and the participant's medical history to identify potentially eligible patients.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Study Assessment

    Other intervention

    * Collection of demographic details (age, sex, ethnicity, alcohol consumption, and smoking status) * Collection of previous/existing results from the participants medical records will include the following: * Medical History: Documented diagnoses, comorbidities, and history of cardiovascular conditions. * Concomitant Medications: Details of all current prescribed and over-the-counter medications relevant to their clinical care. * Physical Examination and Vital Signs: Blood pressure, pulse rate, and any other routinely recorded cardiovascular parameters available within their clinical record. All data will be collected only from information already recorded as part of routine clinical care. In addition to these, the participant will undergo the study assessments: Arterial stiffness, endothelial function, Cardiac output response to stress test and Voice recognition.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Heart Failure with reserved ejection fraction1 intervention
Group B: Heart failure with preserved ejection fraction1 intervention

Trial outcomes

Primary outcomes

1

Change in Arterial stiffness measured by Pulse wave velocity (PWV) using SphygmoCor

Change in arterial stiffness measured using pulse wave velocity (PWV) obtained with the SphygmoCor device from baseline to completion of pharmacological treatment and cardiac rehabilitation.

Time frame
Up to 12 week
2

Change in Endothelial Function Measured by Laser Doppler Flowmetry (LDF)

Change in endothelial function measured using Laser Doppler Flowmetry from baseline to completion of pharmacological treatment and cardiac rehabilitation.

Time frame
Up to 12 weeks

Secondary outcomes

1

Change in Cardiac Output Measured Using the Cardiac Output Response to Stress (CORS) Test

Change in cardiac output measured during the Cardiac Output Response to Stress (CORS) test from baseline to completion of cardiac rehabilitation..

Time frame
Up to 12 weeks
2

Change in Voice-derived Biomarkers Obtained From Voice Recordings

Change in voice-related parameters derived from digital voice recordings from baseline to completion of cardiac rehabilitation.

Time frame
Up to 12 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Coventry University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: