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Clinical Trials/EUCTR2006-001090-23-GB
EUCTR2006-001090-23-GB
Active, not recruiting
Phase 1

Testosterone therapy as an adjunct to exercise rehabilitation: effects on exercise capacity, inflammatory markers and quality of life in hypogonadal males with chronic heart failure. - none

Sheffield Teaching Hospitals NHS Foundation Trust0 sites0 target enrollmentMay 15, 2006

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Congestive heart failure
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Status
Active, not recruiting
Last Updated
6 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 15, 2006
End Date
December 18, 2009
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Eligibility Criteria

Inclusion Criteria

  • Symptoms of hypogonadism
  • Blood testosterone level of up to 15 nmol.l\-1
  • Clinically stable CHF (longer than 6 months, prior to recruitment)
  • Evidence of impairment of left ventricular systolic function (defined by echocardiography as ejection fraction less than 35%)
  • Reduced exercise tolerance (limited by fatigue or breathlessness of cardiac origin)
  • Patients must be over 18 years of age
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1\.2 Adults (18\-64 years) yes
  • F.1\.2\.1 Number of subjects for this age range

Exclusion Criteria

  • Unstable angina
  • Recent acute myocardial infarction
  • Decompensated heart failure
  • Haemodynamically significant valvular heart disease
  • Uncontrolled hypertension
  • Renal insufficiency (serum creatinine \>200umol/l)
  • Urologic disorders
  • Any orthopaedic or neurologic illness limiting the ability to exercise
  • Patients with prostate specific antigen (PSA) level above the age adjusted normal range will also be excluded
  • Patients taking sex hormone therapy

Outcomes

Primary Outcomes

Not specified

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