Effects of Testosterone on Myocardial Repolarization

NCT03126656 | Completed Phase 4

• 1 other identifier: TECHF001
• Study Type: interventional
• Target: 123
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main of the study is to evaluate the effect of testosterone on ventricular repolarization in patients with mild heart failure, at risk for sudden cardiac death. The electrocardiographic markers studied are QT variability index, the short term variability index.

Conditions

Hypogonadism; Chronic Heart Failure

Keywords

testosterone; chronic heart failure

Outcome Measures

Primary Outcomes (1)

• QT duration reduction

  Reduction of the absolute QT interval value and its space and time dispersion

  baseline (before testosterone administration), after 1 month and after 6 months of follow up

Secondary Outcomes (1)

• hypogonadism treatment

  baseline (before testosterone administration), after 1 month and after 6 months of follow up

Study Arms (3)

Hypogonadic with chronic heart failure

EXPERIMENTAL

patients suffering from mild to moderate heart failure (LVEF ≥ 40%, NYHA I-II), and hypogonadism (plasma testosterone levels \<11.4 nmol / L);

Drug: Testosterone Undecanoate

Hypogonadic

EXPERIMENTAL

patients just with hypogonadism (testosterone \<11.4 nmol / L) in the absence of documented cardiovascular disease

Drug: Testosterone Undecanoate

chronic heart failure

NO INTERVENTION

patients suffering from mild to moderate heart failure (LVEF ≥ 40%, NYHA I-II) with normal testosterone levels(plasma testosterone levels \> 11.4 nmol / L), in optimized standard therapy for heart failure

Interventions

Testosterone Undecanoate DRUG

just hypogonadic patients enrolled received hormone replacement therapy with testosterone undecanoate 1000 mg/4ml intramuscular (IM) at baseline, after 6 weeks and 12 weeks after the first evaluation

Hypogonadic; Hypogonadic with chronic heart failure

Eligibility Criteria

• Age: 40 Years - 70 Years
• Gender Eligibility Details: just male patients with hypogonadism or chronic heart failure or both are eligible
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 40 and 70 aa with blood testosterone values \<11.4 nmol / L;
• Sinus rhythm at 12-lead ECG;
• Hypogonadism: Total Testosterone \<3.5 ng / ml or Free testosterone \<250 pmol / L (10 pg / mL) detected (8: 00-11: 00 am) in two successive measurements taken baseline and confirmed at 7 days apart, reduced libido and / or at least two symptoms of hypogonadism evaluated AMS questionnaire
• previous myocardial infarction and relief echocardiographic fraction of left ventricular ejection greater than or equal to 40% (in chronic heart failure patients);
• stable clinical and hemodynamic conditions for more than three months;
• No therapeutic changes in the last 3 months;
• signing the informed consent.

You may not qualify if:

• therapy with testosterone undertaken within 6 months of enrollment or other therapy with steroids undertaken within 3 months thereafter
• Clinical history of prostate cancer
• elevated PSA values (adjusted for age)
• digital rectal exploration (DRE) suggestive of prostate cancer
• Symptoms of benign prostatic hypertrophy (BPH) with severe obstructive symptoms
• Hematocrit\> 52% at baseline
• History of clinically significant hepatic, hematological, renal pathology
• Clinical history of breast cancer
• Hyperprolactinemia or other endocrine diseases (empty sella syndrome and pituitary expansive diseases measured by MRI)
• Age less than 40 or older than 70 years;
• Severe left ventricular systolic dysfunction (left ventricular ejection fraction \<40%) and / or echocardiographic evidence of severe valvular disease;
• chronic atrial fibrillation or frequent extrasystoles (\> 1 extrasystole / min);
• Presence of complete branch block;
• Unstable clinical and hemodynamic conditions and / or changes in therapy over the last three months;
• Presence of prostatic hyperplasia decisive severe obstruction to uroflow study;

Sponsors & Collaborators

• University of Roma La Sapienza: lead

MeSH Terms

Conditions

Hypogonadism

Interventions

testosterone undecanoate

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Syncope Unit I Clinica Medica, Policlinico Umberto I, Rome, Italy, Clinical Professor

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: April 24, 2017
• Study Start: September 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: May 8, 2017

Record last verified: 2017-05