NCT01481402

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Jul 2011

Typical duration for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 29, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

July 16, 2019

Status Verified

February 1, 2014

Enrollment Period

2.6 years

First QC Date

November 25, 2011

Last Update Submit

July 12, 2019

Conditions

Heart FailureLow T3 Syndrome

Keywords

Heart failureLiothyronineLow T3 syndrome

Outcome Measures

Primary Outcomes (1)

  • left ventricle ejection fraction

    The effect of liothyronine treatment in low dose in 3 months on LVEF.

    3 months

Secondary Outcomes (6)

  • Body composition

    3 months

  • Quality of Life, questionaire

    3 months

  • YKL-40, YNF-alpha, hsCRP and IL-6

    3 months

  • RBP 4, HBA1C, adiponectin (high and low weight), glucose and HOMA-1

    3 months

  • GDF 8, SHBG, CK and PINP

    3 months

  • +1 more secondary outcomes

Study Arms (2)

Placebo-liothyronine

PLACEBO COMPARATOR

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

Drug: Liothyronine

Liothyronine-Placebo

OTHER

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

Drug: Liothyronine

Interventions

LiothyronineDRUG

Liothyronine 40 microgram per day

Also known as: T3
Placebo-liothyronine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herlev Hospital, Dept. of Endocrinology

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Heart FailureEuthyroid Sick Syndromes

Interventions

Triiodothyronine

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesThyroid DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ThyroninesThyroid HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsThyroxineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Jens Faber, MDSci

    Herlev Hospital, Dept. of Endocrinology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

November 25, 2011

First Posted

November 29, 2011

Study Start

July 1, 2011

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

July 16, 2019

Record last verified: 2014-02

Locations

DK(1)