Liothyronine and Heart Failure. The Long Term Effect of Liothyronine on Left Ventricular Ejection Fraction (LVEF)

NCT ID: NCT01481402

Last Updated: 2019-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2014-02-28

Brief Summary

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Purpose: The purpose of the study is to examine if treatment with liothyronine increases left ventricular ejection fraction (LVEF) in patients with stable, chronic heart failure.

Detailed Description

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The patients are examined 3 times. At baseline, after 3 months and after 6 months.After the examination is performed, they begin the study medication while admitted at Dept. of Cardiology, Herlev Hospital, for cardiac monitoring.

Conditions

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Heart Failure Low T3 Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo-liothyronine

3 months of placebo followed by 3 months of Liothyronine treatment.

Group Type PLACEBO_COMPARATOR

Liothyronine

Intervention Type DRUG

Liothyronine 40 microgram per day

Liothyronine-Placebo

3 months of Liothyronine treatment followed by 3 months of Placebo treatment.

Group Type OTHER

Liothyronine

Intervention Type DRUG

3 months of placebo followed by 3 months of Liothyronine 40 microgram per day (oral)

Interventions

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Liothyronine

Liothyronine 40 microgram per day

Intervention Type DRUG

Liothyronine

3 months of placebo followed by 3 months of Liothyronine 40 microgram per day (oral)

Intervention Type DRUG

Other Intervention Names

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T3 T3

Eligibility Criteria

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Inclusion Criteria

* Patients with stable, chronic systolic heart failure
* T3 ≤1.4 nmol/l in two blood samples, TSH is to be normal
* LVEF ≤ 45 % on prior echocardiography

Exclusion Criteria

* Established thyroid illness
* Atrial fibrillation/flutter
* More than 20% ventricular extrasystoles
* Severe chronic obstructive lung disorder
* Pregnancy. Pregnancy testing will be done for fertile women
* Age \< 18 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jens Faber

OTHER

Sponsor Role lead

Responsible Party

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Jens Faber

professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jens Faber, MDSci

Role: STUDY_DIRECTOR

Herlev Hospital, Dept. of Endocrinology

Locations

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Herlev Hospital, Dept. of Endocrinology

Herlev, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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HerlevH

Identifier Type: -

Identifier Source: org_study_id

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