BuspiRon for chEmoreflex modulation and central Apnea treatment in Heart failure patients

Phase 1

• Conditions: patient with central apneas syndrome and heart failure; MedDRA version: 20.0Level: LLTClassification code 10011949Term: Decompensation cardiacSystem Organ Class: 100000004849; MedDRA version: 20.0Level: HLTClassification code 10040978Term: Sleep apnoeasSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-005383-42-IT
• Lead Sponsor: FONDAZIONE TOSCANA GABRIELE MONASTERIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-07
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1) Age between 18 and 80 years; 2) Heart failure (diagnosed according to Framingham criteria) with a left ventricular dysfunction (ejection fraction-EF <50%), New York Heart Association (NYHA) classes I-III; 3) Chemoreflex activation to hypercapnia (cut point = 0.79); 4) Central apneas at the cardiorespiratory monitoring, with an AHI= 15 events/hour (moderatesevere central apneas); 5) Capability and possibility to follow and complete the study; 6) Informed consent signature.
Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1) Participation in the previous 3 months to other clinical studies;
2) Pregnant, breast-feeding women or fertile women that do not follow and adequate contraception (every woman must consent to abstinence from sexual intercourse, or adopt any two of the following contraception measures considered efficacious as: bilateral tube ligation, male sterilization, use of hormonal contraceptives that inhibit ovulation, copper intrauterine devices; every barrier device must be used together with a spermicide cream);
3) Recent acute heart failure or acute coronary syndrome (in the last 3 months);
4) Chronic severe renal insufficiency (creatinin clearance <20 ml/min/1.72 m2);
5) Chronic obstructive pulmonary disease (FEV1/FVC<70% and FEV1< 70%);
6) Hepatic insufficiency (transaminases AST/ALT > 100 U/L and/or gamma GT > 150 U/L);
7) Major unstable psychiatric disorders and/or use of psychoactive agents and agents that can influence respiratory drive (ATC: N02A (opiates), N02CC (serotonin agonists), N03 (antiepileptic agents), N04A (anticholinergic agents), N04B (dopaminergic agents), N05 (psycholeptic agents), N06 (antidepressants), S01EC01 (acetazolamide), R03DA (xanthine),
R03DB (xanthine and adrenergic agents);
8) Concomitant use of drugs that inhibit or induce hepatic metabolism, in light of buspiron hepatic
metabolism;
9) History of drug or alcohol dependence;
10) Administration of any experimental drug within 30 days of the enrollment in the present study;
11) Active malignancies;
12) Known or suspected allergy to the drugs subjected to investigation or to one or more of the excipients;
13) Lactose intolerance;
14) Incapability to sign the informed consent form;
15) Closed angle glaucoma;
16) Miastenia gravis;
17) Hereditary galactose intolerance, lactase deficieny or glucose-galactose malabsorption;
18) Any other condition or disease that, to the investigator judgment, may interfere with the present study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified