Single centre randomized study to evaluate the effect of Levothyroxine on cardiac function in patients with chronic heart failure and subclinical hypothyroidism - LEVOTHYROXINE
- Conditions
- chronic heart failure and subclinical hypothyroidismMedDRA version: 9.1Level: SOCClassification code 10007541
- Registration Number
- EUCTR2010-020540-34-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA OSPEDALE POLICLINICO CONSORZIALE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
? Age > 18 years; ? Chronic Heart Failure diagnosis; ? Clinical stable conditions; ? NYHA class II-III; ? TSH levels between 4.5 and 10.0 mUI/L; ? Conventional therapy with the maximum tolerated dose of ACE-inhibitors and/or Angiotensin II Receptor Blockers and/or Beta-blockersn in the last 3 months; ? Willing to participate to the trial by providing for written informed consent.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
? Acute CHF; ? Myocardial infarction or coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) in the last 3 months; ? Diagnosis of hyperthyroidism; ? Pregnancy; ? Unable to complete the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine in patients with stable CHF and hypothyroidism (TSH values 4.5-10 mUI/L) the effect of levothyroxine treatment, in comparison with none treatment, on cardiac function evaluated by means of left ventricular ejection fraction.;Secondary Objective: To determine, in the same patients, the effects of levothyroxine, in comparison with those with none treatment: ? supraventricular and ventricular arrhytmias; ? functional parameters (NYHA class, six minutes walking test, peak VO2); ? quality of life; ? CHF progression (death, heart transplantation or hospitalization).;Primary end point(s): left ventricular ejection fraction
- Secondary Outcome Measures
Name Time Method