Arterial Stiffness and Endothelial Function in Heart Failure

NCT07713719 | Not Yet Recruiting

• 1 other identifier: P185795
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Heart Failure

Keywords

Arterial stiffness; Endothelial Function; Heart failure

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to 12 week

• 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.

  Up to 12 weeks

Secondary Outcomes (2)

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

  Up to 12 weeks

• Change in Voice-derived Biomarkers Obtained From Voice Recordings

  Up to 12 weeks

Study Arms (2)

Heart Failure with reserved ejection fraction

Other: Study Assessment

Heart failure with preserved ejection fraction

Other: Study Assessment

Interventions

Study Assessment OTHER

* 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.

Heart Failure with reserved ejection fraction; Heart failure with preserved ejection fraction

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.
• Able to provide written informed consent.

You may not qualify if:

• 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.
• Severe renal insufficiency.
• Pregnancy (Present or planned).
• Life expectancy less than 12 months

Sponsors & Collaborators

• Coventry University: lead

MeSH Terms

Conditions

Heart Failure

Interventions

Outcome Assessment, Health Care

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Evaluation Mechanisms; Health Care Quality, Access, and Evaluation

Study Officials

• Prithwish Banerjee

  University Hospitals Coventry & Warwickshire NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prithwish Banerjee, MBBS, Dip Card, MD, MRCP, FES

CONTACT

07803711713; Prithwish.Banerjee@uhcw.nhs.uk

Djordje Jakovljevic

CONTACT

07522694321; djordje.jakovljevic@coventry.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 20, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: July 20, 2026

Record last verified: 2026-07