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Single centre randomized study to evaluate the effect of Levothyroxine on cardiac function in patients with chronic heart failure and subclinical hypothyroidism - LEVOTHYROXINE

Single centre randomized study to evaluate the effect of Levothyroxine on cardiac function in patients with chronic heart failure and subclinical hypothyroidism - LEVOTHYROXINE

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-020540-34-IT
Enrollment
Unknown
Registered
2010-09-10
Start date
2009-11-18
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic heart failure and subclinical hypothyroidism MedDRA version: 9.1 Level: SOC Classification code 10007541

Interventions

Trade Name: EUTIROX Pharmaceutical Form: Tablet INN or Proposed INN: Levothyroxine sodium Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 50-

Sponsors

AZIENDA OSPEDALIERA OSPEDALE POLICLINICO CONSORZIALE
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ? 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

Exclusion criteria

Exclusion criteria: ? 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.

Design outcomes

Primary

MeasureTime frame
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—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026