Heart Failure Clinical Trial
Official title:
Urocortins 2 & 3-Effects on Forearm Arterial Blood Flow in Patients With Heart Failure
Verified date | June 2013 |
Source | University of Edinburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | United Kingdom: Research Ethics Committee |
Study type | Interventional |
Despite modern advances in treatment, heart failure continues to carry a poor prognosis with
high morbidity and mortality rates. Hence, there remains a major interest in the development
of novel therapeutic agents for this debilitating condition. Urocortins have recently shot
into limelight with their potential role in the pathophysiology and treatment of heart
failure.
Recent studies by the investigators group (REC no: 09/S1103/41) have confirmed that
Urocortin 2 and 3 are potent arterial vasodilators, the effects of which are reproducible
and well tolerated in healthy male volunteers. Previous studies using heart failure models
in animals1-7, as well studies in heart failure patients (Urocortin 2), suggest that there
is great scope for Urocortins as novel biomarkers and as potential therapeutic agents in
heart failure. With this in mind, the investigators wish to study the local vasomotor
effects of these peptides in greater detail in patients with heart failure.
Status | Completed |
Enrollment | 22 |
Est. completion date | July 2012 |
Est. primary completion date | July 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: Patients with heart failure: 1. Patients with stable heart failure (NYHA class II-IV) on maximum tolerated doses of an ACE inhibitor and beta-blocker for at least 3 months. 2. Baseline echocardiographic parameters (echo performed within last 12 months) at recruitment: ejection fraction (EF) <35%, left ventricular end dimension >5.5cm and fractional shortening <20% 3. Age 18-80 years (inclusive) at recruitment Healthy volunteers: - Age and sex-matched healthy volunteers Exclusion Criteria: 1. Lack of informed consent 2. Age <18 years and > 80 years 3. Current involvement in a clinical trial 4. Systolic blood pressure >190 mmHg or <90 mmHg, untreated malignant arrhythmias 5. Haemodynamically significant valvular heart disease 6. Severe or significant co-morbidity including bleeding diathesis, renal or hepatic failure 7. History of anaemia 8. Recent infective/inflammatory condition 9. Recent blood donation (prior 3 months) 10. Women of child bearing potential |
Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United Kingdom | Wellcome Trust Clinical Research Facility, Royal Infirmary of Edinburgh | Edinburgh |
Lead Sponsor | Collaborator |
---|---|
University of Edinburgh | NHS Lothian |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Forearm blood flow | Difference between forearm blood flow in response to doses of Ucn2, Ucn3 and Substance P between heart failure patients and healthy controls. | 3 hours | No |
Secondary | Absolute forearm blood flow | Absolute forearm arterial blood flow in response to Ucn2, Ucn3 and Substance P. | 3 hours | No |
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